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Reported trial results for Leukaemia

Every Leukaemia trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.

176 trials have reported results.

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

  • NCT03573024 · results posted 11 June 2026

    According to the results reported on ClinicalTrials.gov, this trial enrolled 36 adults who received a combination of two medicines — azacitidine and venetoclax. All 36 participants completed the study. The trial was measuring how many people responded to the treatment combination, using a set of response categories defined by a group called the European LeukemiaNet (which includes things like complete remission — meaning no signs of leukaemia were detectable in standard tests). It also measured how many people achieved what is called "MRD-negative" status, which means that even very sensitive laboratory tests (able to detect as few as 1 in 1,000 leukaemia cells) could not find any remaining leukaemia cells. The reported data shows that out of 36 participants, 25 met the criteria for a positive response according to the European LeukemiaNet definitions. Additionally, 23 out of 36 participants achieved MRD-negative status — meaning highly sensitive testing found no detectable leukaemia cells in those individuals. These are the two figures reported for the main (primary) outcomes of the trial. The trial also planned to measure three additional outcomes — how long any remission lasted, survival free from key disease events at one year, and overall survival (how long participants lived after starting treatment). However, the reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of these three secondary outcomes, so those figures are not available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04161885 · results posted 4 June 2026

    According to the results reported on ClinicalTrials.gov, this trial (NCT04161885) was conducted in two parts. Part 1 involved 35 people and was designed to look at whether certain side effects — called dose-limiting toxicities — occurred when participants received a combination of two medicines, venetoclax and azacitidine, at different dosing schedules. Part 2 was a larger, randomised phase involving 430 people (216 in the best supportive care group and 214 in the venetoclax plus azacitidine group), and its main goal was to measure overall survival — that is, how long participants lived from the time they were enrolled. The reported data shows that in Part 1, 3 out of 30 participants on the 28-day venetoclax schedule experienced dose-limiting toxicities, while 0 out of 5 participants on the 14-day schedule did. For the main question in Part 2 — overall survival — the reported data shows "not available" (NA) for both groups, meaning a final survival figure was not reported in this submission. For one of the secondary measures, a combined outcome tracking how long participants lived without disease relapse or a complication called graft-versus-host disease (GvHD, a condition where transplanted immune cells can attack the body), the reported median time was 11.1 months for the best supportive care group and 12.2 months for the venetoclax plus azacitidine group. A separate measure looking at the percentage of participants who did not develop more serious forms of GvHD at 90 days was reported as 63.4% in the best supportive care group and 58.9% in the venetoclax plus azacitidine group. Several other secondary outcomes, including additional relapse-free survival measures, were also listed as not available in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT05583552 · results posted 12 May 2026

    According to the results reported on ClinicalTrials.gov, this trial (NCT05583552) looked at a drug called imetelstat sodium in people with certain blood cancers (MDS – a bone marrow condition – and AML, a type of leukaemia). A total of 46 people took part, split evenly into two groups of 23: one group received the drug once per treatment cycle, and the other received it twice per cycle. The main thing the trial was measuring was whether participants' blood counts showed a recognised response to treatment, using standard international criteria. A secondary measure tracked how many people experienced side effects (called adverse events) after starting the drug. The reported data shows that when looking at the main measure – an overall blood-count response – zero out of 23 participants in the once-per-cycle group met the response criteria, and one out of 23 participants in the twice-per-cycle group met them. For the side-effects measure, all 23 participants in each group (46 out of 46 total) were reported to have experienced at least one treatment-emergent adverse event (meaning a side effect that appeared or got worse after the first dose). Regarding how long people stayed on treatment, the once-per-cycle group averaged about 54 days and the twice-per-cycle group averaged about 77 days. Compliance – meaning the percentage of planned doses that were actually received – was reported at 70% for the once-per-cycle group and 60% for the twice-per-cycle group. The average total amount of drug received was approximately 1,502 mg in the once-per-cycle group and 2,565 mg in the twice-per-cycle group. It is also worth noting that, according to the reported data, none of the participants in the once-per-cycle group and only 3 out of 23 in the twice-per-cycle group completed the study, with the remainder not completing it; the reasons for this were not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03150004 · results posted 30 March 2026

    According to the results reported on ClinicalTrials.gov, this trial (NCT03150004) enrolled 53 people in total — 40 in the CLAG-M treatment group and 13 in the CLLDAC treatment group. All participants who started the trial were recorded as having completed it. The trial was measuring whether patients achieved a very deep type of remission (called "MRD complete remission," meaning no detectable signs of disease could be found using sensitive tests), as well as how long participants lived overall and how long they remained in remission without their disease coming back. The reported data shows that in the CLAG-M group, 4 out of 40 participants reached this deep level of remission after one cycle of treatment. In the CLLDAC group, 0 out of 13 participants reached that same level after one cycle, and 2 of those 13 went on to receive a second cycle of CLLDAC treatment. For overall survival (how many patients were still alive at up to 4 years), the reported figure was 28.3% for the CLAG-M group and 0% for the CLLDAC group. For progression-free survival in the CLAG-M group (meaning the percentage of those who had achieved remission who had not relapsed or died at up to 4 years), the reported figure was 55.6%. Progression-free survival data for the CLLDAC group was not reported in the submitted results. It is worth noting that these two groups were quite different in size — 40 people versus 13 — so direct comparisons between them should be interpreted with care. The reported numbers simply reflect what was observed in this particular group of trial participants and do not on their own tell us whether one treatment is better than another. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT05115630 · results posted 19 December 2025

    According to the results reported on ClinicalTrials.gov, this trial enrolled 24 participants who were undergoing a stem cell transplant (a procedure where healthy blood-forming cells from a donor are given to a patient). The trial was looking at a treatment approach that combined an infusion of specialised immune cells called NK (natural killer) cells with a preparatory regimen of three medicines/treatments — fludarabine, melphalan, and low-dose radiation (TBI) — given before the transplant. Of the 24 people who started, 21 completed the study and 3 did not. The reported data shows that the main thing the trial was measuring was whether participants experienced "graft failure" — meaning the donated cells failed to take hold and grow in the body within 28 days. According to the results reported on ClinicalTrials.gov, 0 out of the 24 participants experienced this type of graft failure. For the secondary measures, the reported data shows that 4 participants died within 100 days of the transplant from causes other than their disease coming back (this is referred to as "non-relapse mortality"). The data also notes that 10 of the 24 participants had previously undergone a separate donor stem cell transplant before joining this study. It is worth noting that this was a small, single-group study — meaning everyone received the same treatment and there was no comparison group — so the numbers reflect only what was observed in this particular group of participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04266301 · results posted 12 December 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT04266301) enrolled 530 people in total — 265 in each group. One group received a medicine called sabatolimab combined with azacitidine, while the other group received a placebo (an inactive dummy treatment) combined with azacitidine. The main thing the trial was measuring was overall survival — that is, how long participants lived from the time they were enrolled in the study until death from any cause. The trial also measured several secondary things, including how long it took for fatigue to get noticeably worse, how many days per year participants went without needing a red blood cell transfusion, and whether participants reported improvements in fatigue and physical functioning on standardised questionnaires. The reported data shows that, for overall survival, participants in the sabatolimab plus azacitidine group had a reported median survival time of around 22.2 months, compared with around 18.8 months in the placebo plus azacitidine group. (Median means the point at which half the participants in that group had passed away and half had not.) For the secondary measures, the reported data shows that the time before fatigue meaningfully worsened was around 13.4 months in the sabatolimab group versus 11.8 months in the placebo group. The average number of days per year spent free from red blood cell transfusions was reported as approximately 184 days in the sabatolimab group and 176 days in the placebo group. Around 39.6% of participants in the sabatolimab group reported a meaningful improvement in fatigue scores, compared with 40.8% in the placebo group. For physical functioning, approximately 30.2% of the sabatolimab group reported a meaningful improvement, compared with 22.6% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04150029 · results posted 17 November 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT04150029) enrolled 90 people in total — 5 in a lower-dose group receiving MBG453 400 mg combined with two other medicines (venetoclax and azacitidine), and 85 in a higher-dose group receiving MBG453 800 mg with the same two medicines. The trial was looking at a combination treatment for a blood cancer condition and measured two main things: first, how many participants in the lower-dose "safety check" phase experienced certain serious side effects during the early part of the study (called dose-limiting toxicities); and second, how many participants in the higher-dose group achieved a full remission (meaning no detectable signs of the disease by specific medical criteria). The reported data shows that in the safety check phase, 0 out of 5 participants in the 400 mg group experienced a dose-limiting toxicity, while 1 out of 85 participants in the 800 mg group did. For the main effectiveness measure, the reported data shows that approximately 47% of participants in the 800 mg group achieved a complete remission. The trial also measured several secondary outcomes: around 69% of participants in the 800 mg group (and 80% in the 400 mg group) achieved either a full remission or a remission where blood counts had not fully recovered. When looking at participants who achieved remission and had their disease measured at a very detailed level, the reported data shows that approximately 74% in the 800 mg group and 100% in the 400 mg group showed no detectable trace of disease by that sensitive test. For the 800 mg group, the reported average length of time people stayed in full remission was about 10.3 months; this figure was not reported for the 400 mg group. It is worth noting that no participants formally "completed" the study as defined by the trial's own criteria, and the groups were very different in size, which can make direct comparisons between them difficult to interpret. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03263936 · results posted 16 October 2025

    According to the results reported on ClinicalTrials.gov, this trial enrolled 37 people in total across three groups, each receiving a different dose of a drug called decitabine combined with a chemotherapy regimen known as FLAG (which includes the drugs fludarabine, high-dose cytarabine, and G-CSF, plus vorinostat). The main thing the trial was measuring was how much decitabine could be given alongside this combination — specifically, by looking at whether participants experienced what researchers call a "dose-limiting toxicity" (a serious side effect severe enough to prevent increasing the dose further). Three participants were in the lowest dose group (7.5 mg/m²), 22 were in the middle dose group (10 mg/m²), and 12 were in the highest dose group (15 mg/m²). The reported data shows that no dose-limiting toxicities were recorded in any of the three dose groups during the first cycle of treatment. Of the 37 participants who started the study, 35 completed it — two participants in the middle dose group did not complete the study, though the data does not report the reasons why. No further outcome measures beyond this primary one appear to have been submitted to ClinicalTrials.gov, so additional details about how participants responded overall are not available from this record. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT05168202 · results posted 25 September 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT05168202) enrolled 56 people in total across seven treatment groups (called Part A, Treatments 1 through 7), with group sizes ranging from 5 to 10 participants. The trial was an early-phase study, meaning its main focus was on closely monitoring participants for any unwanted medical events rather than testing whether the treatment produced a particular health benefit. Notably, the reported data shows that zero participants were recorded as having "completed" the study in any group — the reasons for this were not detailed in the submitted data. The reported data shows the following counts of medical events across the seven groups. Regarding serious dose-limiting reactions (unexpected or severe events occurring early in treatment): 0, 1, 0, 0, 0, 2, and 4 participants experienced these across the seven groups respectively. When it came to any unwanted medical event arising during treatment, nearly all participants across every group were recorded as having at least one — ranging from 5 to 10 people per group. Severe laboratory test abnormalities (graded at level 3 or higher on a standard medical scale) were reported in 4, 6, 7, 8, 7, 10, and 5 participants across the groups. Heart-tracing (ECG) abnormalities reported as medical events were recorded for 1 participant in Treatment 1 and 2 participants in Treatment 6, with zero in the remaining groups. Changes in vital signs (such as blood pressure or pulse) flagged as medical events were reported in small numbers across most groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02752035 · results posted 12 September 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT02752035) looked at treatments for a type of blood cancer called acute myeloid leukaemia (AML). It tested a drug called gilteritinib, either on its own or combined with another drug called azacitidine (AZA), compared to azacitidine alone. A total of 15 people took part in an initial safety testing phase, and then 168 people were randomly assigned to one of three groups: gilteritinib combined with AZA (89 people), AZA alone (57 people), or gilteritinib alone (22 people). The main thing the trial was measuring was overall survival — that is, how long participants lived from the time they were enrolled. The reported data shows that for overall survival, the median time — meaning the point at which half the participants in each group had passed away — was approximately 9.82 months for the gilteritinib plus AZA group, 9.23 months for the AZA-alone group, and 5.24 months for the gilteritinib-alone group. For a secondary measure called "event-free survival" (the time until the disease worsened, treatment failed, or death occurred), the reported median figure was 0.03 months across all three groups, suggesting that for most participants this point was reached very early. The reported data also shows that the proportion of participants achieving a full remission (where the disease could no longer be detected by standard measures) was 25.8% in the gilteritinib plus AZA group, 17.5% in the AZA-alone group, and 9.1% in the gilteritinib-alone group. When broader remission categories were combined, the figures were 61.8%, 28.1%, and 54.5% respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04102020 · results posted 20 August 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT04102020) enrolled 112 people across five groups. The trial was testing two different drug combinations in people with a blood cancer condition. One part of the trial (Part 1) looked at the drug venetoclax combined with an injected form of azacitidine at three different doses — 20, 36, or 50 mg/m² — with 23, 23, and 20 participants respectively. Another part (Part 3) tested venetoclax combined with a tablet form of azacitidine (called CC-486) at two dose levels — 200 mg or 300 mg — with 30 and 16 participants respectively. The main thing being measured was how many people in each group experienced what are called "dose-limiting toxicities" — that is, serious side effects significant enough to signal that a dose may be too high. The reported data shows that in Part 1, a total of 3 participants in the lowest azacitidine dose group, 4 in the middle dose group, and 4 in the highest dose group experienced these dose-limiting toxicities. In Part 3, the reported data shows 1 participant in the lower CC-486 dose group and 2 in the higher dose group experienced dose-limiting toxicities overall. The data also breaks these down into subcategories (such as blood-related versus non-blood-related toxicities), with small numbers reported across each subgroup. Notably, the reported data shows that no participants were recorded as having "completed" the study — all participants across every group were listed as "not completed," though the reasons for this were not detailed in the structured results provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02719574 · results posted 26 June 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT02719574) tested a drug called FT-2102 (also known as olutasidenib) in people with certain blood cancers, including acute myeloid leukaemia (AML) and a condition called myelodysplastic syndrome, that carried a specific gene change called an IDH1 mutation. The trial ran in two main stages: a Phase 1 stage to explore different doses and combinations (either FT-2102 alone or paired with other medicines called azacitidine or cytarabine), and a Phase 2 stage testing several groups of patients. In total, across all groups and stages, several hundred participants were enrolled — roughly 37 people in the Phase 1 dose-escalation stage, 41 in the Phase 1 dose-expansion stage, and 258 in the Phase 2 stage, giving an overall total of around 336 participants. The reported data shows that in Phase 1, one of the main things measured was how many participants experienced adverse events (unwanted medical events that occurred during treatment) and serious adverse events (those involving hospitalisation, life-threatening situations, or death). Among participants taking FT-2102 alone across both Phase 1 stages, 31 out of 31 participants experienced at least one adverse event during treatment, and 23 out of 31 experienced a serious adverse event. Among those taking FT-2102 combined with azacitidine, 39 out of 46 experienced at least one adverse event and 30 out of 46 experienced a serious adverse event. For Phase 2, the main thing measured was the percentage of patients who achieved a complete remission (meaning their cancer showed no detectable signs in bone marrow tests and their blood counts recovered) or a near-complete remission with partial blood count recovery. The reported data shows that in Cohort 1 (patients with relapsed or treatment-resistant AML taking FT-2102 alone), 35% of participants met this combined response measure. Results for other Phase 2 cohorts were also reported, though the full figures for all cohorts were not completely captured in the available data extract. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗

  • NCT02521493 · results posted 13 June 2025

    According to the results reported on ClinicalTrials.gov, this trial enrolled 280 people in total across three groups: 114 in the "Standard Risk" group (Arm A), 44 in the "High Risk" group (Arm B), and 122 in a "No Risk Stratification" group. The trial was measuring how well participants fared over time after treatment for what appears to be a blood cancer, specifically looking at something called "event-free survival" — that is, how many people went for at least two years without their illness coming back, failing to respond to treatment, developing a second cancer, or dying. The reported data shows that, among the Standard Risk group (Arm A), approximately 89.4% of participants were event-free at the two-year mark, while in the High Risk group (Arm B), that figure was approximately 80.5%. These percentages were estimated using a statistical method called Kaplan-Meier, which is a standard way of tracking how many people in a group remain free of a particular event over time. The trial also planned to report on a number of other outcomes — including overall survival, early deaths, treatment-related deaths, length of time on treatment, and relapse rates — however, no numbers for those outcomes were included in the data submitted to ClinicalTrials.gov, so those results cannot be described here. It is also worth noting that while 89 of the 114 Standard Risk participants and 38 of the 44 High Risk participants were recorded as having completed the study, none of the 122 participants in the "No Risk Stratification" group were recorded as completing it, and no outcome results were reported for that group. The reasons for this were not included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03286114 · results posted 11 May 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT03286114) enrolled 16 people, all of whom received a drug called pembrolizumab. The trial was looking at a type of blood cancer (leukaemia), and its main goals were to find out how many participants showed a "clinical benefit" — meaning their disease either stabilised or reduced — and how many had a measurable response to treatment. The trial also tracked serious immune-related side effects, including a condition called Graft Versus Host Disease (GvHD), where the immune system attacks the body's own tissues. The reported data shows that 6 out of 16 participants showed some form of clinical benefit (stable disease, partial remission, or complete remission). Of those, 3 participants had a measurable response — meaning their disease showed a partial or complete remission. Regarding immune-related side effects, the reported data shows that 9 participants experienced GvHD or other significant immune-related reactions, and 2 participants experienced a separate recorded measurement in this same category (the data does not provide further detail to distinguish between these two figures). It is also worth noting that 9 of the 16 participants did not complete the study, though the reasons were not broken down in the submitted data. The reported data shows that for secondary outcomes, 37.5% of participants were recorded as alive at one year, and 31.3% were recorded as alive and free from disease at one year. Seven participants completed the study in full. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04285567 · results posted 17 April 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT04285567) enrolled 80 people in one group receiving a combination called VEN+G (venetoclax plus obinutuzumab) and 86 people in a comparison group receiving either FCR or BR (established chemotherapy-based regimens). The trial was looking at a type of blood cancer called chronic lymphocytic leukaemia (CLL). The main thing being measured was something called "minimal residual disease" (MRD) negativity in the blood — in plain terms, this means whether very sensitive testing could detect any remaining cancer cells after treatment, with a finding of "MRD-negative" meaning fewer than 1 cancer cell detected in every 10,000 white blood cells. The reported data shows that none of the participants were recorded as having formally "completed" the study, which may reflect how the trial's milestones were recorded rather than meaning everyone dropped out. The reported data shows that for the main outcome — MRD negativity in the blood at a key assessment point — 81.3% of participants in the VEN+G group and 54.7% in the FCR/BR group had results below the detection threshold. For secondary outcomes, the proportion of participants showing an overall response (meaning their disease met criteria for at least a partial improvement) was reported as 88.8% in the VEN+G group and 79.1% in the FCR/BR group. The proportion reaching a complete response (the deepest level of response measured) was 50.0% versus 32.6% respectively. MRD negativity measured in bone marrow (a more intensive test done in certain participants) was reported as 70.0% for VEN+G and 38.4% for FCR/BR. For the secondary outcome measuring progression-free survival — that is, how long participants went without their disease worsening or dying — the reported figure for the FCR/BR group was 53.3 months, while the figure for the VEN+G group was listed as "NA" (not available/not reported), meaning a median could not yet be calculated from the data submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT05079230 · results posted 4 April 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT05079230) enrolled 378 adults with acute myeloid leukaemia (a type of blood cancer). Participants were randomly assigned to one of two groups of 189 people each: one group received a combination of three medicines — magrolimab, venetoclax, and azacitidine — while the other group received the same two medicines (venetoclax and azacitidine) plus a placebo (a dummy version of magrolimab). The trial was primarily measuring how long participants lived overall, and also tracked several secondary measures including how many people's cancer went into remission (meaning signs of the disease became undetectable) and how long that remission lasted. No participants were recorded as having completed the study, meaning the trial ended or was stopped before all participants finished their planned treatment course. The reported data shows that the median overall survival — that is, the midpoint time at which half of participants in each group had died — was 10.7 months in the magrolimab combination group and 14.1 months in the placebo combination group. For the secondary outcomes, the reported data shows that 47.6% of people in the magrolimab group and 53.4% in the placebo group achieved a full or near-full remission within six treatment cycles. Looking at full remission alone, the figures were 41.3% and 46.0% respectively. Among those who did reach remission, the median duration of that remission was reported as 9.4 months in the magrolimab group and 9.2 months in the placebo group (or 8.1 months when counting full remission only). The reported event-free survival — the median time before the disease returned, failed to respond, or a participant died — was reported as 0.0 months for the magrolimab group and 1.7 months for the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03953898 · results posted 30 March 2025

    According to the results reported on ClinicalTrials.gov, this trial looked at a drug called olaparib in people with certain blood cancers (myelodysplastic syndrome or acute myeloid leukaemia). Fourteen people were enrolled, and 12 of those went on to start treatment. The trial was measuring how many participants had their cancer respond to the treatment over up to six cycles, as well as how long people lived without their disease getting worse, how long they survived overall, and how many experienced unwanted side effects. The reported data shows that, out of the 12 participants who started treatment, none (zero) met the criteria for a response to the drug — meaning no one achieved any of the defined response categories (such as complete remission or partial response) at any point during the six cycles. For the secondary measures, the reported median progression-free survival — that is, the midpoint time before the disease got worse — was 2.3 months, and the reported median overall survival was 3.4 months. All 12 participants who started therapy experienced at least one non-serious unwanted side effect, according to the reported data. No figures were reported for duration of response, as that data was not submitted. It is worth noting that no participants were recorded as having formally "completed" the study, and 14 were listed as not completing it — the reasons for this were not detailed in the submitted data. The small number of people involved (12 who received treatment) means these figures come from a very limited group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04284787 · results posted 13 March 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT04284787) enrolled 60 people in total — 31 in one group receiving two drugs (azacitidine and venetoclax, sometimes called AZA and VEN), and 29 in a second group receiving those same two drugs plus a third drug called pembrolizumab. The trial was mainly measuring how many participants achieved a specific type of deep remission — known as "MRD-negative complete remission" — which broadly means that very sensitive testing could no longer detect signs of the disease in the blood or bone marrow after treatment. None of the participants formally "completed" the trial as defined by the study protocol, and all were recorded as not having completed it, though the reported data shows that 29 people in each group did receive the trial therapy. The reported data shows that for the primary outcome — that deep remission measure — 13 participants in each group reached the target response. The data also includes figures of 7 and 9 participants in each group across what appear to be different response sub-categories within the same primary outcome, though the labels distinguishing these sub-groups were not fully detailed in the submitted data. For the secondary outcome, which tracked how many people in the pembrolizumab group developed severe side effects (called "severe toxicity"), the reported number was zero participants. It is worth noting that the biomarker-related outcomes (additional measurements looking at biological markers in the blood and tissue) had no numerical results submitted — the data for those outcomes was not reported on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04971226 · results posted 10 March 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT04971226) enrolled 405 people in total across four groups. Participants were split based on which type of leukaemia medicine they had previously taken, and then randomly assigned to receive either asciminib or a medicine chosen by their doctor (called an "investigator selected TKI" — a type of targeted cancer tablet). The trial's main goal was to measure how many people in each group achieved something called a "Major Molecular Response" (MMR) by week 48. MMR means that the amount of a specific leukaemia-related signal detected in a person's blood had fallen to a very low level — specifically, to no more than one-thousandth of a reference starting point. Around 85–88 people in the asciminib groups and 63–77 people in the comparator groups completed the study. The reported data shows that, when looking at all participants who received asciminib together, 136 people were reported as having achieved MMR at week 48. In the group receiving the investigator-selected medicine, 100 people were reported as having achieved MMR at the same point. It is important to note that these are raw counts of participants, not percentages, and the total number of people evaluated in each combined group is not separately stated in the submitted data. For the secondary outcomes — including MMR at week 96, MMR at other scheduled time points, a deeper level of response called MR4.0, and time to stopping treatment due to side effects — the reported data shows that no numerical results were submitted to ClinicalTrials.gov for these measures, so those figures cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04666038 · results posted 7 March 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT04666038) enrolled 119 participants in each of two groups — 238 people in total — with a type of blood cancer called chronic lymphocytic leukaemia or small lymphocytic lymphoma. One group received a medicine called pirtobrutinib, while the other received one of two established combination treatments (idelalisib plus rituximab, or bendamustine plus rituximab). The trial's main goal was to measure how long participants went without their disease getting worse or dying — a timeframe known as "progression-free survival." The reported data shows that, for the primary measure, the pirtobrutinib group went a median of about 14.0 months without disease progression or death, compared with about 8.7 months in the comparison group, as assessed by an independent review committee. When the treating doctors made the same assessment themselves, the reported figures were approximately 15.3 months for the pirtobrutinib group and 9.2 months for the comparison group. For overall survival (the time from entering the trial until death from any cause), the pirtobrutinib group had a reported median of around 29.7 months; a comparable figure for the other group was not reported in the data. The reported data also shows that participants in the pirtobrutinib group went a median of about 24.0 months before needing a further cancer treatment, versus about 10.9 months in the comparison group. For the remaining secondary measures, the reported data shows that the pirtobrutinib group had a median of around 14.1 months before experiencing disease progression, starting a new treatment, stopping due to unacceptable side effects, or dying — compared with about 7.6 months in the comparison group. Regarding the proportion of participants whose disease responded to treatment, approximately 66.4% of the pirtobrutinib group and 48.7% of the comparison group were reported to have had a measurable response, as assessed by their treating doctors. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04745676 · results posted 10 February 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT04745676) looked at whether a telehealth-based advance care planning program — helping people plan ahead for future medical decisions — was practical to run and easy to use. A total of 36 people took part across three groups: 20 patients (of whom 21 were approached and agreed to join), 6 caregivers, and 10 clinicians. The trial measured how many people stayed in the study, how many signed up, and how easy the telehealth platform was to use. It also tracked changes in participants' anxiety, depression, and distress scores before and after the program. The reported data shows that nearly all participants who enrolled finished the study — 19 out of 20 patients, all 6 caregivers, and all 10 clinicians completed everything. For ease of use, the telehealth platform was rated using a questionnaire scored from 1 to 7, where a score above 5 is considered usable. Both patients and caregivers reported an average score of 5.9; no usability score was reported for clinicians. For the secondary measures, anxiety scores (on a 0–21 scale, where higher means more anxiety) changed by an average of +0.1 for patients and −2.8 for caregivers from before to after the program. Depression scores (0–27 scale) changed by +0.4 for patients and −1.0 for caregivers. Distress scores (0–10 scale) changed by +0.3 for patients and −1.3 for caregivers. No secondary outcome figures were reported for clinicians. It is important to note that this was a small study primarily designed to test whether this kind of program could be run smoothly and whether the technology was usable — it was not designed to draw firm conclusions about any broader effects. The reported changes in anxiety, depression, and distress scores are descriptive numbers from this small group only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT05447663 · results posted 14 January 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT05447663) was testing a drug called siremadlin (also known as HDM201) in people with acute myeloid leukaemia (a type of blood cancer) who had undergone a stem cell transplant. The trial was designed in two parts: the first part looked at siremadlin on its own to find a tolerable dose, and the second part was planned to test siremadlin combined with a treatment called donor lymphocyte infusion (a transfusion of immune cells from the original stem cell donor). Eight participants were enrolled in the first part of the trial, receiving a 30mg dose of siremadlin. No participants were recorded as having completed the study. The reported data shows that, for the main question asked in Part 1 — how many participants experienced a "dose-limiting toxicity" (meaning a serious side effect severe enough to potentially affect the dose used) — the answer was 1 out of 8 participants. For all other outcome measures, including those planned for Part 2 (such as how long it took for a dose-limiting toxicity to occur in the combined treatment group, and how many participants remained in remission), no numerical results were reported on ClinicalTrials.gov. This likely reflects the fact that the trial did not progress to Part 2, as zero participants were recorded as completing the study overall. The reported data also notes that one participant was switched to a lower 10mg dose due to a medication interaction. Because Part 2 of the trial does not appear to have taken place, the majority of the planned measurements — including those looking at remission rates, relapse-free survival, and longer-term leukaemia relapse rates at one and two years — were listed as outcome measures but have no figures attached to them in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02890329 · results posted 7 January 2025

    According to the results reported on ClinicalTrials.gov, this trial looked at a combination of two drugs — decitabine and ipilimumab — given to people with certain blood cancers (acute myeloid leukaemia or myelodysplastic syndrome). The trial had two main groups: people who had already received a bone marrow transplant (Arm A), and people who had not (Arm B). Across three rounds of testing at increasing doses, a total of 54 people took part. The trial was primarily trying to find the highest dose of ipilimumab that could be given alongside decitabine without too many serious dose-related side effects — this is known as the "maximum tolerated dose." The reported data shows that for both groups — those who had received a prior bone marrow transplant and those who had not — the maximum tolerated dose of ipilimumab was identified as 10 mg/kg (milligrams per kilogram of body weight). This was the highest dose level tested in the trial. In practical terms, this means that at this dose level, no more than one in six participants in each group experienced what the researchers defined as a significant dose-limiting reaction, meeting the trial's pre-set threshold. The trial also planned to measure a number of other things, including how participants' cancers responded to treatment, how long they lived without their cancer getting worse, how long they survived overall, and whether transplant recipients developed a complication called graft-versus-host disease (where transplanted cells attack the body). However, the reported data shows that no numerical results for any of these secondary outcomes were submitted to ClinicalTrials.gov, so those figures are not available to describe here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02488408 · results posted 19 December 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT02488408) tested a drug called bemcentinib (also known as BGB324) in people with certain blood cancers, specifically acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS). The trial ran in two stages. In the first stage (Part A), 36 people took part across five groups, each receiving different doses of bemcentinib on its own, to find out what the highest tolerable dose was. In the second stage (Part B), 86 people took part across five groups, receiving bemcentinib either alone or combined with other medicines (cytarabine or decitabine). The trial was measuring things like what dose could be used, what unwanted medical events (called adverse events) occurred after starting treatment, and whether participants' cancer showed any measurable response. The reported data shows that in Part A, the highest dose identified through the dose-finding process was 600 mg (as a starting or "loading" dose), with 200 mg as the ongoing maintenance dose. Regarding unwanted medical events that emerged during treatment, all participants in every group experienced at least one such event — the reported numbers matched the total number of participants in each group across both Part A and Part B. For physical examination findings, vital signs, lab tests, and heart tracing (ECG) results, the reported data shows zero participants in any group had notable abnormal trends recorded by investigators. Regarding measurable cancer response, the reported data shows that in Part A, between 0% and 33.3% of participants in different dose groups showed an objective response. In Part B, the reported response percentages ranged from 0% (in the bemcentinib plus decitabine group) to 35.7% (in one of the bemcentinib plus cytarabine groups), with other groups reporting figures of approximately 17–19%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02397720 · results posted 4 November 2024

    According to the results reported on ClinicalTrials.gov, this trial enrolled 156 participants across six treatment groups, though one group (Arm 3B) did not end up including any participants. The trial tested different combinations of medicines — azacitidine paired with nivolumab alone, or with the addition of either ipilimumab or venetoclax — in people with a blood cancer. The trial was looking at things like the highest dose that could be given without too many serious side effects in the early "lead-in" phases (6 participants each), as well as how many people showed a response to treatment, and how long participants lived or stayed free from disease progression. The reported data shows that for the dose-finding part of the trial, the starting doses tested — 75 mg/m² for azacitidine and 3 mg/kg for nivolumab — were identified as the maximum tolerated doses across all three lead-in groups, meaning fewer than 2 out of 6 participants in each group experienced a serious dose-limiting reaction in the first 28 days. For the number of participants who showed a measurable response to treatment, the reported figures were: 2 out of 6 in the azacitidine-nivolumab lead-in group, 34 out of 85 in the larger azacitidine-nivolumab group, 2 out of 6 and 13 out of 47 in the two ipilimumab groups, and 4 out of 6 in the venetoclax lead-in group (no participants were enrolled in the sixth group, so no data was reported for it). The reported data shows that for time-based measurements, disease-free survival (the time from starting treatment until signs of disease returning) ranged from 2.0 to 4.1 months across the groups. The time until disease got worse or death from leukaemia (called progression-free survival) ranged from 1.3 to 3.6 months. Overall survival — the time from starting treatment until death from any cause or last follow-up — ranged from 1.4 to 8.3 months across the groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04277442 · results posted 22 October 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT04277442) enrolled only one participant, who was assigned to receive a combination of three medicines: nivolumab, decitabine, and venetoclax. The trial was designed to test whether this combination was feasible — meaning whether patients could get through three full rounds ("cycles") of treatment — and to track any unwanted side effects. The original plan had been to enrol 13 people, with the goal considered met if at least 10 of them completed three cycles. The reported data shows that the single participant who started the trial did not complete it. On the primary outcome of completing three cycles of therapy, the reported number was zero out of one. Similarly, zero participants achieved a remission response by cycle three, as defined by the trial's criteria. Regarding side effects (called "adverse events"), the data shows that across twelve categories of side effects that were tracked, the one participant registered a count of one in each category — meaning side effects were recorded, though the data does not break down further detail about their nature or severity beyond this count. For the secondary outcomes — which looked at how long the disease took to progress, how long the participant survived overall, and anti-tumour activity — the reported figures were zero participants for progression-free survival and overall survival. No measurements were reported for the anti-tumour activity outcome. Given that only one person participated and the trial did not reach its intended size, the reported data is very limited in what it can show. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03541369 · results posted 10 October 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT03541369) tested a drug called emirodatamab — given alone or in combination with another medicine called etanercept — in a total of 74 people across 18 different dosing groups. Participants were assigned to receive different dose levels or combinations, and the trial was primarily a "first-in-human" study, meaning it was an early-stage trial designed to explore how the drug behaves in the body at various dose levels and to track any serious medical events that occurred within a defined window after dosing. The trial also measured how the drug moved through the body over time (its blood concentration levels). According to the results reported on ClinicalTrials.gov, the primary outcome tracked two things: first, whether participants experienced a "dose-limiting toxicity" (a pre-defined serious medical event occurring within a set timeframe after dosing); and second, whether participants experienced any medical events that arose during or after treatment. The reported data shows that, out of the 12 dosing groups for which data was provided, 1 participant in Cohort 7a and 1 participant in Cohort 11 were recorded as having experienced a dose-limiting toxicity. All participants across every reported group for whom data was available experienced at least one medical event during the treatment period. The reported data also shows that the peak blood concentration of emirodatamab — how much of the drug was detected in the blood at its highest point — varied considerably across the different dose groups, ranging from very low levels (0.00 ng/mL in some lower-dose groups) up to 124 ng/mL in one group. Data for several other outcome measures, including some of the blood concentration figures for certain cohorts, was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01838395 · results posted 19 September 2024

    According to the results reported on ClinicalTrials.gov, this trial enrolled 42 people in total across six dose groups. Participants received a combination of two treatments: BL-8040 (given as an injection under the skin) and a chemotherapy drug called Ara-C. The trial tested increasing doses of BL-8040 — starting at 0.5 mg per kilogram of body weight and going up to 2.0 mg per kilogram — to measure how well the combination was tolerated and to track what happened in participants' blood and bone marrow. Most participants completed the study, with three people across all groups not finishing. The reported data shows that the primary focus was on tracking adverse events (unwanted medical occurrences) across all 42 participants combined and within each dose group. The full breakdown of those adverse events was only partially reported in the submitted data, so complete figures for all categories are not available here. For the secondary outcome measuring response in the bone marrow, the reported data shows that in the 1.5 mg/kg dose group (the largest group, with 23 participants), 4 people met criteria for a full response and 5 met criteria for a partial response. Smaller numbers of partial responses were recorded in the 1.0 mg/kg and 1.25 mg/kg groups (2 and 1 participants respectively), and no responses were reported in the other dose groups. The trial also tracked how quickly BL-8040 was absorbed and cleared from the blood; the reported data shows that the peak blood concentration of BL-8040 increased with each higher dose, ranging from 380 ng/mL at the lowest dose to 4,020 ng/mL at the highest dose. No numerical data for the measure of changes in leukaemic cell death was reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03735875 · results posted 19 September 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT03735875) looked at a combination of two medicines — venetoclax and quizartinib — in people with a type of blood cancer (leukaemia). The trial had two planned stages: a Phase I (dose-finding) stage and a Phase II stage. The reported data shows that 8 participants were enrolled into the Phase I dose-finding group, and all 8 completed that stage. No participants were enrolled into the Phase II group, so all results below relate only to the Phase I stage. The reported data shows that the highest dose of venetoclax that participants could tolerate alongside quizartinib — known as the "maximum tolerated dose" — was recorded as 30 milligrams. For the time-based measurements, the reported figures were: the average length of time a response lasted (duration of response) was 1.5 months; the time from starting treatment until the disease got worse or death from leukaemia (progression-free survival) was 2.3 months; the time from starting treatment until treatment failure or death from any cause (event-free survival) was also 2.3 months; and the time from starting treatment until death from any cause or last check-in (overall survival) was 3.7 months. The reported data also shows that none of the 8 participants went on to receive a stem cell transplant — a procedure where a person receives healthy blood stem cells — following their treatment on this trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02997202 · results posted 19 September 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT02997202) enrolled 178 participants in the gilteritinib group and 178 in the placebo group — 356 people in total. The trial was looking at people who had received a stem cell transplant for a type of blood cancer called acute myeloid leukaemia (AML) that carried a specific gene change known as FLT3. The main thing the trial was measuring was how long participants went without their disease coming back (called "relapse-free survival"). It also tracked a number of other things, including how long participants lived overall, their general ability to carry out everyday activities, deaths that occurred for reasons other than the disease returning, and any unwanted medical events that happened during the study. The reported data shows that the numbers for the two main time-based measures — relapse-free survival and overall survival — were listed as "not available" (NA) in the data submitted to ClinicalTrials.gov, meaning those figures were not reported in this structured dataset. For the other outcomes, the reported data shows that 175 out of 178 participants in the gilteritinib group and 162 out of 177 in the placebo group experienced at least one unwanted medical event during or shortly after treatment. Regarding deaths that occurred for reasons other than the disease returning, the reported figures were 13.6% of participants in the gilteritinib group and 6.6% in the placebo group. A general wellbeing score (the Karnofsky scale, where 100 means feeling completely normal and 0 means death) was also recorded; the reported data shows scores of around 84 for both groups at one time point, and around 93 and 92 respectively at another time point — though the specific timing of these measurements was not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04023526 · results posted 30 July 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT04023526) enrolled 103 adults in total — 51 received a lower dose of cusatuzumab (10 mg/kg) combined with azacitidine, and 52 received a higher dose (20 mg/kg) combined with azacitidine. The trial was measuring how often participants with acute myeloid leukaemia (a type of blood cancer) achieved what doctors call a "complete remission" — meaning that by certain blood and bone marrow tests, signs of the leukaemia had fallen below a defined threshold. By the end of the study period, 46 participants in the lower-dose group and 42 in the higher-dose group had completed the study. The reported data shows that for the main outcome — the proportion of participants reaching complete remission — approximately 11.8% of those in the lower-dose group and 26.9% of those in the higher-dose group met that measure. For the secondary outcomes, the reported data shows that when a slightly less strict version of remission (called "complete remission with partial blood-count recovery") was added to the full remission figures, the combined rate was about 21.6% in the lower-dose group and 34.6% in the higher-dose group. Looking at the broadest measure of response — which included all three remission categories — the reported figures were approximately 29.4% for the lower-dose group and 40.4% for the higher-dose group. A smaller subset was also assessed for whether any detectable leukaemia cells remained after remission: 1 participant in the lower-dose group and 4 in the higher-dose group were reported to have reached full remission with no detectable remaining leukaemia cells by that measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04703192 · results posted 22 July 2024

    According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called valemetostat tosylate and was carried out in two separate groups of patients. The first group (Cohort 1) included 133 people with a type of blood cancer called relapsed or refractory peripheral T-cell lymphoma (PTCL) — meaning their cancer had come back or stopped responding to previous treatment. The second group (Cohort 2) included 22 people with a related blood cancer called adult T-cell leukemia/lymphoma (ATCL). The trial measured how many participants showed a measurable response to the medicine, as well as tracking unwanted side effects that appeared during treatment. The reported data shows that in Cohort 1, the main thing being measured was the proportion of participants whose cancer showed a response — either a complete response (cancer no longer detectable) or a partial response (cancer reduced but still present) — as judged by an independent review team who did not know which treatment patients received. According to the results reported on ClinicalTrials.gov, 43.7% of eligible Cohort 1 participants fell into this category. For Cohort 2, the main measure was how many participants experienced side effects that appeared or worsened after starting the medicine; the reported data shows all 22 participants in that group recorded at least one such side effect. Several other planned measurements — including how long responses lasted, the rate of complete responses, and drug levels in the blood — were listed but no numerical results were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04629443 · results posted 6 June 2024

    According to the results reported on ClinicalTrials.gov, this was a Phase I dose-escalation trial (NCT04629443) testing an investigational drug called S64315 (also known as MIK665) given together with another medicine called azacitidine. The trial enrolled 17 people in total, split across three groups receiving different doses of S64315: 5 people received 50 mg, 7 people received 100 mg, and 5 people received 190 mg. The trial was primarily measuring how the body tolerates increasing doses of the drug — looking at serious dose-limiting reactions, unwanted side effects (called adverse events), and how consistently the drug could be delivered over time. No participants were recorded as having completed the study. The reported data shows that when it came to dose-limiting toxicities — that is, side effects serious enough to prevent increasing the dose — none occurred in the 50 mg group, while 1 was recorded in each of the 100 mg and 190 mg groups. For general adverse events (unwanted health events of any kind), the reported numbers were 72 events in the 50 mg group, 56 in the 100 mg group, and 41 in the 190 mg group. Of these, severe adverse events numbered 39, 22, and 13 respectively. Serious adverse events — a more specific medical category meaning hospitalisation or life-threatening events — were recorded as 16, 14, and 5 across the three groups, with fatal serious adverse events reported as 2, 2, and 0. The reported data also shows that dose interruptions and reductions occurred across all groups, and the actual average weekly dose delivered was lower than the target in each group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03426605 · results posted 3 May 2024

    According to the results reported on ClinicalTrials.gov, this trial tested a drug called LAM-003 in 17 people with a blood cancer (acute myeloid leukaemia, or AML). Participants were split into four groups, each receiving a different daily dose: 200 mg (6 people), 300 mg (3 people), 450 mg (4 people), and 600 mg (4 people). The main goal was to find the highest dose that could be given without causing serious dose-related side effects — known as the "maximum tolerated dose." The trial also tracked how the drug moved through the body (its blood levels over time) and whether participants' tumours showed any measurable response. Notably, none of the participants completed the study; all 17 did not finish, though the reasons for this are not detailed in the reported data. The reported data shows that no dose-limiting side effects were recorded in any of the four dose groups during the first treatment cycle, meaning the primary measure returned zero events across all groups. For the secondary measure looking at side effects (adverse events) more broadly, all participants in every group — that is, all 17 people — experienced at least one adverse event of any kind, and smaller numbers in each group experienced more serious ones (3 out of 6 in the 200 mg group, 2 out of 3 in the 300 mg group, 1 out of 4 in the 450 mg group, and 2 out of 4 in the 600 mg group). For tumour response, the reported data shows that zero participants in any group met the criteria for a complete or partial response; small numbers — 3, 1, 2, and 3 participants across the four groups respectively — were recorded under a third response category, though the specific label for that category is not detailed in the submitted data. The reported data also shows how drug levels built up in participants' blood, with the peak concentration (the highest level measured) and the overall exposure (the total amount of drug detected over time) both varying across dose groups, but the data does not follow a straightforward pattern where higher doses always produced higher blood levels. These blood-level measurements are used by researchers to understand how the body processes the drug, rather than to judge whether it works. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02283177 · results posted 2 February 2024

    According to the results reported on ClinicalTrials.gov, this trial looked at how people with a type of blood cancer (leukaemia) responded when a drug called crenolanib was given alongside standard chemotherapy. A total of 44 people took part — 29 who were aged 60 or under, and 15 who were older than 60. Of these, 42 completed the study (28 in the younger group and 14 in the older group), with one person from each group not completing it. The reported data shows that the main thing being measured was how many participants' leukaemia went into remission (meaning signs of the cancer were greatly reduced or undetectable in bone marrow tests). Out of 38 participants whose responses were assessed across both age groups, 34 reached full remission (where blood counts also fully recovered), and 4 reached a remission where blood counts had not fully recovered. One participant had a partial response (some improvement but not full remission), and the data does not report a figure for those whose disease did not respond. For the secondary measure — how many participants were still alive three years after starting treatment — the reported data shows 71.4% of those aged 60 and under, 33.3% of those over 60, and 58% of all patients combined were recorded as still alive at that point. It is important to note that these figures simply describe what was measured and counted in this particular group of trial participants, and should not be read as a guarantee of what any individual might experience. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04800510 · results posted 5 December 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT04800510) enrolled 9 participants in total, all of whom completed the study. It was a crossover-style trial, meaning each participant tried multiple conditions in different orders. The conditions tested were: no custom device (NoCDO) and three different custom device options labelled A, B, and C (CDOA, CDOB, CDOC). The main thing the trial was measuring was joint contact stress-time exposure at the ankle — essentially, how much load or pressure builds up inside the ankle joint with each step during walking. Several secondary measurements were also taken, including ankle movement, ankle forces, and pressure under the foot. The reported data shows that the main measurement — joint contact stress-time exposure — was 3.9 units (MPa-s per gait cycle) with no device, 3.5 with device A, 4.1 with device B, and 2.7 with device C. For ankle range of motion (how far the ankle bends during walking), the figures were 17.8 degrees with no device, 16.0 with device A, 16.3 with device B, and 15.5 with device C. Peak ankle moment (a measure of rotational force at the ankle) was 1.5 for no device, 1.5 for device A, 1.5 for device B, and 1.4 for device C. Peak ankle power was 2.9 with no device, 1.8 with device A, 1.6 with device B, and 2.4 with device C. For pressure across the whole foot, the figures were 406.5, 415.1, 428.6, and 424.7 respectively, and for pressure under the front part of the foot specifically, they were 199.0, 165.7, 135.2, and 149.9. No measure of spread or variability around these figures was reported in the submitted data. It is worth noting that only 9 people took part, which is a very small number, and no information about statistical significance (that is, whether the differences between conditions are likely to be meaningful or just due to chance) was reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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  • NCT01823198 · results posted 7 November 2023

    According to the results reported on ClinicalTrials.gov, this trial involved people receiving a stem cell transplant who were also given an infusion of specialised immune cells called NK (natural killer) cells. The trial ran in two stages — a Phase I stage to test different dose levels of NK cells (from lowest to highest), and a Phase II stage that focused on two of those dose levels. In total, 42 patients took part across all groups, along with 21 cell donors. The trial was primarily measuring whether the NK cell infusions caused serious side effects (called "dose-limiting toxicities") and also tracked how many participants survived and how many experienced serious (Grade 3) side effects within 42 days. The reported data shows that in the Phase I stage, 2 out of 6 participants at the lowest dose level, and 1 out of 6 at the next dose level, experienced a dose-limiting toxicity. No dose-limiting toxicities were reported at the two higher dose levels tested in Phase I, nor in either group during Phase II (which included 1 and 21 participants respectively). For overall survival, the reported data shows that across all groups, a number of participants did not survive: 2 deaths were recorded at the lowest Phase I dose level, and smaller numbers (0–1) at each of the other Phase I levels, with 7 deaths reported in the larger Phase II group at the highest dose level. The reported data on Grade 3 side effects within 42 days followed a broadly similar pattern — higher numbers were seen in the larger groups, with 11 out of 21 participants in the biggest Phase II group recorded as having experienced such side effects. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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  • NCT04055844 · results posted 7 November 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT04055844) enrolled 14 participants, all of whom received a combination treatment of three agents — decitabine, ruxolitinib, and donor lymphocyte infusion (DLI, which involves giving immune cells from the original stem cell donor). The trial was studying people whose blood cancer (either AML — a type of leukaemia — or MDS — a bone marrow disorder) had come back after a stem cell transplant from a donor. The trial was measuring how many participants were still alive over time, whether the disease progressed, and whether participants developed a complication called graft-versus-host disease (where donor immune cells attack the recipient's body). Notably, the data shows that none of the 14 participants were recorded as having "completed" the study, and all 14 were listed as "not completed," though the reasons for this were not detailed in the submitted data. The reported data shows that 36% of participants were alive at the primary overall survival time point measured, and 14% were alive at a later secondary overall survival time point. Regarding how long participants lived without their disease getting worse (called progression-free survival), the reported figures were 14% at one time point and 7% at another. The data also shows that 71% of participants experienced a relapse — meaning their cancer returned or worsened. It is important to note that the specific time points at which these percentages were measured (for example, 6 months or 1 year) were not included in the submitted data, so direct comparison between figures is not possible based on what was reported. The reported data also shows that 43% of participants developed moderate-to-severe acute graft-versus-host disease (rated Grade II–IV, meaning ranging from noticeable symptoms to life-threatening). This was measured as a secondary outcome. No other outcome figures beyond those listed above were included in the submitted data, so no further numbers can be described. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03067571 · results posted 21 September 2023

    According to the results reported on ClinicalTrials.gov, this trial enrolled 7 participants, all of whom were in a single treatment group receiving a medicine called daratumumab. All 7 participants completed the study. The trial was measuring whether the treatment could produce a measurable response in people's disease — specifically, improvements in blood cell counts and bone marrow test results, using standard criteria set by an international medical working group. The reported data shows that out of the 7 participants, **0 participants** met the criteria for a measurable response to the treatment. For the secondary measurements, the reported data shows that participants spent an average of **1.1 months** on the treatment, and the time before signs of disease progression was also reported as an average of **1.1 months**. Overall survival — meaning the time from the start of treatment until death from any cause or the last recorded follow-up — was reported as an average of **4.2 months**. It is worth noting that with only 7 participants, these figures reflect a very small group of people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03224819 · results posted 1 September 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT03224819) tested a medicine called emerfetamab in a total of 47 people across 14 groups. Each group received a different dose or dosing schedule of emerfetamab, ranging from very small amounts (0.05 micrograms) up to 110 micrograms. The trial was primarily measuring how many participants experienced unwanted medical events (called adverse events) after receiving the treatment, and how many experienced particularly serious unwanted events called dose-limiting toxicities — a term meaning side effects severe enough that the dose could not be increased further. It also measured how the drug moved through the body over time (for example, how high the drug level in the blood got, and how quickly it was reached). The reported data shows that across the 12 groups for which adverse event numbers were recorded, every participant in those groups experienced at least one treatment-emergent adverse event (that is, an unwanted medical event that appeared after receiving the medicine). Regarding dose-limiting toxicities, the reported data shows that most groups had zero or very few participants affected: no dose-limiting toxicities were reported in the lowest-dose groups, while 1 was reported in the 4.5 µg group, 1 in the 18 µg group, 3 in the 36 µg group, and 2 in the 110 µg group. Notably, the figures for the two Schedule B groups (72 µg and 110 µg) were not reported for either primary outcome measure. For the drug level measurements, the reported data shows that the peak level of emerfetamab in the blood generally rose as the dose increased, and that peak levels were typically reached within about half an hour to just over one hour after dosing. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03734016 · results posted 27 July 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT03734016) compared two medicines — zanubrutinib and ibrutinib — in people with a type of blood cancer called chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). A total of 327 people were assigned to the zanubrutinib group and 325 to the ibrutinib group, with 324 in each group actually receiving their assigned medicine. The trial's main goal was to measure how many participants showed a response to treatment (meaning their disease showed signs of reducing), and it also tracked how long that response lasted and how long participants went without their disease getting worse. The reported data shows that, when doctors running the trial assessed responses, 83.5% of participants in the zanubrutinib group and 74.2% in the ibrutinib group showed a response. When an independent review committee assessed the same participants (a separate check done for regulatory purposes), the figures were 86.2% for zanubrutinib and 75.7% for ibrutinib. For the secondary measure of how long participants went without their disease progressing, the median time (the point by which half the group had experienced progression or death) was not yet reached for the zanubrutinib group at the time of reporting, while it was reported as 34.2 months for the ibrutinib group based on the treating doctors' assessments, and 35.0 months based on the independent committee's assessments. Similarly, how long responses lasted had not yet reached a median for the zanubrutinib group, while it was reported as 33.9 months for the ibrutinib group. The trial also tracked a heart rhythm irregularity called atrial fibrillation or flutter, reporting it in 5.2% of the zanubrutinib group and 13.3% of the ibrutinib group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01614197 · results posted 27 July 2023

    According to the results reported on ClinicalTrials.gov, this trial enrolled 16 people in total across four groups, each receiving a different dose level of the study treatment (3 people in Dose Level 1, 4 in Dose Level 2, 6 in Dose Level 3, and 3 in Dose Level 4). The trial was studying a treatment for a blood cancer condition, and its main goal was to find out how many participants experienced a "dose-limiting toxicity" (a serious side effect severe enough to set an upper limit on the dose) during the first round of treatment. It also looked at how participants' disease responded after one cycle of treatment. The reported data shows that, for the primary measure, out of the participants assessed at each dose level, no dose-limiting toxicities were recorded in Dose Levels 1, 2, or 4 (0 out of 3 participants each), while 1 out of 5 assessed participants experienced one in Dose Level 3. For the secondary measure looking at disease response after one cycle, the reported data shows that across the four dose groups: complete remission (disease appearing to clear with blood count recovery) was recorded in 0, 1, 1, and 0 participants respectively; complete remission without full blood count recovery was recorded in 1, 0, 0, and 1 participants; and partial remission was recorded in 1, 1, 1, and 0 participants. Some response category breakdowns (such as stable disease and progressive disease) were not reported in the submitted data. For the measure of remaining detectable disease at the end of cycle one, the reported data shows most participants across dose levels still had detectable disease remaining, with smaller numbers (0, 1, 1, and 1 across the four groups) recorded as having undetectable levels. It is worth noting that this was a very small, early-phase trial, and the reported data describes only what was observed and measured in these 16 participants — it was not designed to draw broad conclusions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗

  • NCT02842827 · results posted 11 July 2023

    According to the results reported on ClinicalTrials.gov, this trial tested a drug called bomedemstat, given at different daily doses, either on its own or combined with another drug called tretinoin. A total of 45 people took part, spread across eight different dosing groups ranging from lower to higher doses. The trial was primarily designed to track what unwanted effects (called adverse events) participants experienced during treatment, and to look for a specific type of serious reaction known as a dose-limiting toxicity — meaning a reaction severe enough that the dose could not safely be continued. The reported data shows that across all eight groups, every single participant who received treatment experienced at least one adverse event. Serious adverse events — meaning reactions that led to hospitalisation, were life-threatening, or had other major consequences — were also reported in nearly all participants: 3 out of 3 in the lowest-dose group, and similarly high numbers across all other groups, with 9 out of 9 in one of the higher-dose combination groups. The number of participants who stopped treatment because of an adverse event ranged from 0 to 3 depending on the group. Notably, the reported data shows that no participant in any group experienced a dose-limiting toxicity during the first 28 days of treatment. A smaller number of participants experienced what the trial called "medical events of interest" — specific concerns such as bleeding or infection — ranging from 0 to 3 participants per group. Only 3 out of 45 participants were recorded as having formally completed the study. The reported data does not include secondary outcome results beyond these adverse event measurements, so no further figures are available to describe here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03512197 · results posted 18 June 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT03512197) enrolled 501 people — 250 in the midostaurin plus chemotherapy group and 251 in the placebo plus chemotherapy group. Participants had a type of blood cancer (acute myeloid leukaemia, or AML) and were randomly assigned to receive standard chemotherapy together with either midostaurin (a targeted medicine) or a placebo (an inactive treatment). The trial was primarily measuring "event-free survival" — that is, how long participants went before experiencing a treatment setback such as failing to reach remission, having the disease return, or dying. The reported data shows that the median event-free survival — meaning the point in time by which half the participants had experienced one of those setbacks — was approximately 5.98 months in the midostaurin group and 5.88 months in the placebo group. For overall survival (how long participants lived after joining the trial), the reported median was 19.22 months in the placebo group; a corresponding figure for the midostaurin group was listed as "not available" in the submitted data. The reported data also shows that around 59% of the midostaurin group and 61% of the placebo group reached complete or near-complete remission. Roughly 41% of participants in both groups achieved what is called "MRD-negative status" — meaning that sensitive tests could no longer detect cancer cells below a certain threshold — at some point during the trial. During a later phase of treatment (post-consolidation), that figure was 33.3% in both groups. The time from joining the trial to first reaching MRD-negative status was reported as approximately 2.27 months (midostaurin group) and 2.07 months (placebo group). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03634228 · results posted 15 June 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT03634228) tested a combination of two medicines — a low dose of a chemotherapy drug called cytarabine and an experimental drug called DS-3032b (an MDM2 inhibitor) — in people with a blood cancer. The trial had a Phase I part, focused on finding a safe dose, and a planned Phase II part. A total of 16 people took part across three dose-level groups in Phase I (3 people in Cohort 0, 6 in Cohort 1, and 7 in Cohort 2). The reported data shows that no participants were enrolled into the Phase II part of the trial. The reported data shows that the primary goal of Phase I — finding the maximum tolerated dose, meaning the highest dose at which no more than one in six participants experienced serious side effects in the first treatment cycle — resulted in a figure of 260 milligrams for DS-3032b. For the secondary question of how many participants showed a measurable response to treatment (based on specific blood and bone marrow criteria), the numbers reported were: 0 out of 3 participants in Cohort 0, 1 out of 6 in Cohort 1, and 1 out of 7 in Cohort 2. The reported data also shows figures for how long participants survived overall and how long before their disease showed signs of returning. For overall survival, the reported median (middle) values were 2.1 months for Cohort 0, 4.3 months for Cohort 1, and 7.6 months for Cohort 2. For the time before disease relapse, the reported median figures were 1.9 months, 2.4 months, and 1.8 months respectively. It is worth noting that these groups were very small, so these figures reflect only the participants in this trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03173248 · results posted 23 March 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT03173248) enrolled 146 people with a type of blood cancer, randomly divided into two groups: 72 people received a combination of a drug called AG-120 (ivosidenib) plus azacitidine, and 74 people received a placebo (an inactive substance) plus azacitidine. The trial's main goal was to measure "event-free survival" — that is, how long participants went without their treatment failing to produce a full remission, without their cancer returning, or without dying. None of the participants were recorded as having completed the study in the conventional sense, meaning all had either left the study early or experienced one of these defined events before the study ended. The reported data shows that for the primary measure — event-free survival — the median time (the point at which half of participants had experienced an event) was reported as 0.03 months in both the AG-120 plus azacitidine group and the placebo plus azacitidine group. This is an extremely short figure, and it likely reflects that a large proportion of participants in both groups experienced a defined "event" (such as not achieving full remission by week 24) very early on. For all of the secondary outcome measures — including complete remission rate, overall survival, response rates, and combined remission rates — no numerical results were reported in the data submitted to ClinicalTrials.gov. Because the secondary outcome data was not reported in the submitted results, it is not possible to describe what those measures found. The reported primary outcome numbers are presented here exactly as submitted, without interpretation of what they mean clinically. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02980731 · results posted 22 February 2023

    According to the results reported on ClinicalTrials.gov, this trial enrolled 210 participants, all of whom received a treatment called venetoclax. The trial was focused on measuring how participants *felt* during treatment — specifically, whether their self-reported quality of life changed over time. Participants completed a standard questionnaire called the EORTC QLQ-C30, which asks people to rate various aspects of their health and wellbeing. Scores on this questionnaire range from 0 to 100, where a higher score means better functioning or quality of life. The reported data shows that none of the 210 participants were recorded as having "completed" the study in the formal sense, meaning all were counted under "not completed" — though this does not necessarily mean they all dropped out, as this can reflect how the trial's data was recorded. The reported data shows that the main (primary) thing being measured was the change in participants' overall sense of health and quality of life from the start of the trial to Week 48. At that point, the average score on the overall quality-of-life scale had changed by +9.3 points compared to where participants started. According to the questionnaire's own guidelines, a change of 5–10 points is considered a small change. The secondary measurements tracked this same score at multiple earlier time points, with reported changes ranging from +3.9 points (early in the trial) up to +11.2 points at one stage, before sitting at +4.8 points at the last recorded time point. Other aspects of wellbeing were also tracked across multiple time points — including physical functioning (changes ranged from +1.2 to +6.1), ability to carry out daily roles (+2.6 to +11.6), emotional wellbeing (+1.4 to +6.1), and thinking and memory (+1.1 to +5.6). All of these remained largely within the "small change" range across the time points reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02049515 · results posted 21 February 2023

    According to the results reported on ClinicalTrials.gov, this trial enrolled 99 people in total — 90 in the IPI-145 (duvelisib) group and 9 in the ofatumumab group. Both groups received at least one dose of their assigned study drug. The trial was measuring how often participants' cancer showed signs of responding to treatment, and how long those responses lasted. The reported data shows that for the primary measure — the overall response rate, meaning the percentage of participants whose disease showed a defined level of improvement — 76.7% of people in the IPI-145 group met the response criteria, while 0% of people in the ofatumumab group did. For the secondary measures, the reported data shows that among IPI-145 participants who had a documented response, the median duration of that response (the midpoint time before the disease progressed or the person died) was reported as 14.9 months. The median progression-free survival — meaning the midpoint time that participants went without their disease worsening or dying — was reported as 15.3 months for the IPI-145 group. Duration of response and progression-free survival figures for the ofatumumab group were not reported in the submitted data. It is worth noting that the two groups were very different in size (90 versus 9 participants), and no one in the IPI-145 group was recorded as having completed the study, which may reflect how the trial's endpoint or stopping rules were defined — however, the submitted data does not explain this further. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02993523 · results posted 27 January 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT02993523) enrolled participants with a blood cancer (acute myeloid leukaemia) who were not suitable for standard intensive chemotherapy. The main group studied consisted of 145 people who received a placebo plus a drug called azacitidine, and 286 people who received a drug called venetoclax combined with azacitidine. A smaller separate group of 10 people in China received venetoclax plus azacitidine in an open-label arrangement (meaning everyone knew which treatment was being given). The trial was primarily measuring how long participants lived overall, and how many achieved a strong reduction in cancer cells in their bone marrow (called complete remission, or CR/CRi). The reported data shows that, for overall survival, participants in the placebo plus azacitidine group had a median survival (meaning half lived longer and half lived shorter than this point) of 9.6 months, while those in the venetoclax plus azacitidine group had a median survival of 14.7 months. For the remission measure, the reported data shows that approximately 17.9% of participants in the placebo plus azacitidine group achieved complete remission (CR), compared with 38.8% in the venetoclax plus azacitidine group, and 60.0% in the open-label China cohort. A related but slightly less strict measure of remission (CRi) was reported at 11.0%, 28.0%, and 20.0% for those same three groups respectively. For the secondary outcomes — including event-free survival, quality of life, and additional remission measures — no numerical results were included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02869633 · results posted 20 January 2023

    According to the results reported on ClinicalTrials.gov, this trial enrolled 23 people across two groups. Sixteen participants had either Chronic Lymphocytic Leukaemia (CLL) or Mantle Cell Lymphoma (MCL) — these are types of blood cancer — and were placed in Cohort A. Seven participants had Follicular Lymphoma or Hodgkin Lymphoma and were placed in Cohort B. The trial was looking at what happened to participants after a stem cell transplant, including how long they went without their disease getting worse, as well as detailed measurements of immune system cells in their blood. The reported data shows that the main outcome measured was "progression-free survival probability at 12 months" for Cohort A — in plain terms, this is the estimated likelihood that a patient's disease had not worsened or returned, and that they had not died from non-disease causes, within a year of their transplant. The reported figure for this group was 0.80, which means 80 out of every 100 people in that group were estimated to have reached the 12-month point without their disease progressing or dying from other causes. This figure applied only to Cohort A participants who were treated with a drug called ibrutinib alongside their transplant. For all of the secondary outcomes — which included immune cell measurements and tests looking for tiny traces of remaining disease — the reported data shows that no numerical results were submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02101853 · results posted 6 December 2022

    According to the results reported on ClinicalTrials.gov, this trial enrolled children and young people who had been diagnosed with a type of blood cancer called B-cell acute lymphoblastic leukaemia (B-ALL) that had come back after previous treatment (known as a relapse). A total of 669 participants entered the first stage of the trial (an initial chemotherapy phase called Block 1 Induction). After that, participants were sorted into risk groups — high/intermediate risk or low risk — and then randomly assigned to one of two treatment approaches to compare outcomes. A separate group of 27 participants received a salvage (rescue) therapy called blinatumomab. The trial was mainly measuring how long participants stayed free of their disease returning or worsening, which is called "disease-free survival." The reported data shows the following figures for the two main groups in the high/intermediate-risk category, measured over two years: roughly 39% of those in the standard chemotherapy group (Arm A) remained disease-free, compared with around 54% of those who received blinatumomab instead (Arm B). For the low-risk group, measured over three years, approximately 59% of those receiving chemotherapy alone (Arm C) remained disease-free, compared with around 67% of those who received chemotherapy plus blinatumomab (Arm D). These percentages represent the proportion of participants who had not experienced a setback such as relapse, treatment failure, or death during the follow-up period. The reported data also includes figures for overall survival — that is, the percentage of participants still alive at the follow-up point. For the high/intermediate-risk group, the two-year overall survival figure was reported as approximately 58% for Arm A and 71% for Arm B. For the low-risk group, the three-year overall survival figure was approximately 88% for Arm C and 90% for Arm D. Results for two other planned measures (relating to minimal residual disease and remission rates in salvage patients) were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03268954 · results posted 22 September 2022

    According to the results reported on ClinicalTrials.gov, this trial enrolled 454 people in total — 227 in each group. Participants had certain blood and bone marrow conditions, including myelodysplastic syndromes (MDS), a related condition called chronic myelomonocytic leukaemia (CMML), or a form of acute myeloid leukaemia with a low number of abnormal cells. One group received a chemotherapy medicine called azacitidine on its own, while the other group received azacitidine combined with an investigational medicine called pevonedistat. The main thing the trial measured was "event-free survival" — the length of time before a participant either died or their condition progressed to a more advanced form of leukaemia. The reported data shows that, for the main measure (event-free survival), the azacitidine-only group had a median of 15.7 months, while the combination group had a median of 17.7 months. (Median here means the point at which half the participants in each group had experienced an event and half had not.) For overall survival — time from the start of the trial until death from any cause — the reported median was 16.8 months for the azacitidine-only group and 20.3 months for the combination group. The reported data also shows that an estimated 82.5% of the azacitidine-only group and 81.0% of the combination group were alive at six months. At the one-year mark, those estimated figures were 69.3% and 64.6% respectively. Within the first 30 days of starting treatment, 6 participants in the azacitidine-only group and 5 in the combination group died; within 60 days, those numbers were 15 and 14 respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02577406 · results posted 10 September 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT02577406) enrolled 319 people in total — 158 in the AG-221 group and 161 in the Conventional Care Regimens (CCRs) group. The trial was comparing these two approaches in people with a particular type of blood cancer (acute myeloid leukaemia), and the main thing it was measuring was overall survival — that is, how long participants lived after being randomly assigned to one of the two groups. The reported data shows that the median overall survival (the point at which half the participants in each group had died) was 6.5 months for the AG-221 group and 6.2 months for the CCRs group. For the secondary measures, the number of participants who showed a meaningful response to treatment was reported as 64 out of 157 in the AG-221 group, compared with 16 out of 141 in the CCRs group. The reported median event-free survival — meaning the time before disease worsening or death — was 4.9 months for AG-221 and 2.6 months for CCRs. Among those who did respond, how long that response lasted (duration of response) was reported as 7.4 months for AG-221 and 33.3 months for CCRs, though it should be noted the numbers of participants who responded in each group were quite different. The time it took for a response to first appear was similar in both groups — around 58 days for AG-221 and 56 days for CCRs. The number of deaths within the first 30 days of starting treatment was reported as 10 in the AG-221 group and 13 in the CCRs group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02287233 · results posted 29 August 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT02287233) looked at a combination of two medicines — venetoclax and low-dose cytarabine (LDAC) — in people with a type of blood cancer called acute myeloid leukaemia (AML). The trial had two stages: a smaller Phase 1 stage to check dosing, involving 8 people receiving a 600 mg dose of venetoclax and 10 people receiving an 800 mg dose; and a larger Phase 2 stage involving 76 people all receiving the 600 mg dose. Notably, zero participants were recorded as having "completed" the study across all three groups, meaning all participants left the study before its formal end — the reasons for this are not broken down further in the reported data. The reported data shows that in Phase 1, the trial measured whether participants experienced what are called "dose-limiting toxicities" (DLTs) — meaning serious or life-threatening side effects during the first treatment cycle that would indicate a dose was too high. In the 600 mg group, zero out of 8 participants had a DLT recorded. In the 800 mg group, 1 out of 10 participants had a DLT recorded. The trial also tracked how the medicines moved through the bloodstream. For venetoclax, the reported peak blood concentration reached roughly 2.04–2.92 µg/mL in the 600 mg group and 2.26–2.36 µg/mL in the 800 mg group, with peak levels occurring somewhere between 4 and 8 hours after dosing. For cytarabine, peak blood concentrations were similar across both groups (around 166–175 ng/mL) and were reached very quickly, at approximately 0.3 hours after dosing. The reported data covers only these Phase 1 measurements; detailed outcome numbers for the larger Phase 2 group were not reported in the structured results data available on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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  • NCT02795182 · results posted 1 July 2022

    According to the results reported on ClinicalTrials.gov, this trial enrolled 75 people in total across four groups, each receiving different dose combinations of two medicines — zanubrutinib (a tablet taken daily) and tislelizumab (an infusion given every three weeks). The trial was testing what doses of these two medicines could be used together, and then looked at how participants' cancers responded. All participants had types of B-cell blood cancers, including various forms of lymphoma. Notably, none of the participants were recorded as having "completed" the study in the formal sense — all 75 either withdrew, progressed, or were still in follow-up when the data was recorded. The reported data shows that one of the main goals of the early part of the trial was to find a "recommended Phase 2 dose" (that is, the dose considered suitable to carry forward into larger studies) for tislelizumab when used alongside zanubrutinib. The reported recommended dose was 200 mg. A separate measure — the "maximum tolerated dose" (the highest dose before too many people experience significant side effects) — was recorded as "not applicable," meaning it was not formally reached or reported. Regarding unwanted side effects, the reported data shows that across the four dosing groups, between 7 and 40 participants experienced treatment-related side effects (called treatment-emergent adverse events), and between 4 and 23 participants in each group experienced serious adverse events. The reported data shows that when looking at how participants' cancers responded — broken down by cancer type — the proportion of people whose cancer showed a complete or partial response ranged from about 25% to 43% depending on the cancer group. For how long those responses lasted, the reported figures ranged from approximately 6.8 months to 22.4 months across the cancer subgroups (one subgroup's figure was not reported). The reported time from starting treatment until the cancer progressed or death occurred — called progression-free survival — ranged from approximately 1.4 months to about 16.9 months across the different cancer types. These numbers describe what was measured in this specific group of trial participants and do not tell us how any individual might respond. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01177540 · results posted 28 June 2022

    According to the results reported on ClinicalTrials.gov, this trial enrolled 25 people in total — 11 in the group that received decitabine combined with standard induction chemotherapy (Treatment A), and 14 in the group that received standard induction chemotherapy alone (Treatment B). One person in Treatment A did not complete the study; everyone in Treatment B did. The trial was primarily measuring how many participants achieved what is called a "complete remission" (CR) — meaning their bone marrow showed no detectable leukaemia and their blood counts recovered to certain levels. It also tracked a number of secondary measures, including changes in DNA methylation (chemical tags on DNA that can affect how genes behave), survival outcomes, and signs of remaining disease after treatment. The reported data shows that 27.3% of participants in Treatment A (the decitabine combination group) achieved a complete remission, compared with 50.0% in Treatment B (chemotherapy alone). Among those who did reach complete remission, the reported median time to get there was 43 days in Treatment A and 37 days in Treatment B. For leukemia-free survival and overall survival, the data was not reported (recorded as "NA" in the submission). Regarding minimal residual disease — tiny amounts of leukaemia that may remain after treatment — 75% of participants in Treatment A had detectable residual disease at baseline, dropping to 25% after treatment; for Treatment B, the baseline figure was not reported, and 11% had detectable residual disease after treatment. For DNA methylation, the reported data shows that 4,134 genetic loci (specific locations on DNA) showed changes in Treatment A, compared with 785 in Treatment B, with a further 2,856 and 305 loci respectively showing a separate category of methylation change. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03850535 · results posted 21 June 2022

    According to the results reported on ClinicalTrials.gov, a total of 23 people took part in this trial across four groups: three groups received increasing doses of the study treatment during an induction phase (4, 9, and 6 participants respectively), and a fourth group of 4 participants took part in a post-consolidation phase. The trial was primarily measuring how many participants experienced certain side effects — specifically serious side effects, and side effects severe enough to require a change in dosing (called "dose-limiting toxicities") — at different dose levels. It is worth noting that the sponsor ended the trial early, before a planned second phase could begin. According to the reported data, this decision was not related to safety concerns but was instead due to the company's broader strategy regarding the condition being studied (a type of blood cancer in adults). The reported data shows the following numbers across the four groups. For dose-limiting toxicities during the first treatment cycle, 2 participants in the lowest-dose group and 4 participants in the middle-dose group experienced these, while none were reported in the highest-dose group or the post-consolidation group. For serious side effects (graded at level 3 or above on a standard medical scale, meaning relatively severe), the reported numbers were 4, 9, 5, and 4 participants across the four groups respectively — which, for the first two groups, represents every person who enrolled. The reported data also shows that at least one adverse event (any unwanted health occurrence) was recorded for all 23 participants across all four groups. Several other planned measurements — including tracking nausea over time using a patient self-reporting tool — were not analysed. According to the results reported on ClinicalTrials.gov, the sponsor noted that the small number of participants and limited follow-up time meant those analyses were not considered meaningful to carry out. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03151408 · results posted 10 March 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT03151408) enrolled 406 people in total — 203 in each group. One group received a combination of pracinostat and azacitidine (a chemotherapy medicine), while the other received a placebo (inactive pill) plus azacitidine. The trial's main goal was to measure overall survival — that is, how long participants lived from the time they were randomly assigned to a group. The reported data shows that no participants were recorded as having formally "completed" the study, and all were listed as "not completed," which may reflect how the trial tracked its endpoint rather than dropout. The reported data shows that for the primary measure — overall survival — both groups had a median (middle value) of 303 days. For the secondary measures, 24 people in the pracinostat-plus-azacitidine group achieved a full remission (cancer going into a very low or undetectable state) compared with 35 in the placebo-plus-azacitidine group. When looking at remission with no detectable remaining disease cells, 12 people were recorded in the pracinostat group versus 20 in the placebo group. For a return to normal chromosome patterns at remission, 7 versus 8 participants were reported respectively. The reported data shows that 81 participants in each group reached a point where they no longer needed blood or platelet transfusions for at least eight consecutive weeks. For an additional pre-specified measure — a broader category combining several types of remission responses — the reported data shows 73 participants in the pracinostat group and 64 in the placebo group met those combined criteria. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02112916 · results posted 23 February 2022

    According to the results reported on ClinicalTrials.gov, this trial (AALL1231) enrolled 847 young people with either T-cell acute lymphoblastic leukaemia (T-ALL) — a cancer of the blood — or T-cell lymphoblastic lymphoma (T-LLy) — a related cancer of the lymph system. Participants were randomly placed into one of two treatment groups: one received a standard combination chemotherapy regimen (Arm A), and the other received the same chemotherapy plus an additional medicine called bortezomib (Arm B). The trial's main goal was to measure "event-free survival" over three years — that is, the percentage of participants who did not experience a setback such as the cancer returning, a new cancer, treatment failure, or death during treatment. The reported data shows that, looking at the primary measure across all participants, 81.7% of those in the standard chemotherapy group (Arm A) and 85.1% of those in the chemotherapy-plus-bortezomib group (Arm B) were event-free at three years. For a secondary measure comparing participants in this trial who did not receive brain radiation therapy against similar participants from an earlier trial (AALL0434) who did receive it, the three-year event-free survival figures were reported as 88.3% and 88.8% respectively. The reported data also shows that 78% of all participants experienced a side effect graded as serious (Grade 3 or higher) according to a standard medical rating scale. Among a smaller subgroup of very high-risk T-ALL patients, those whose cancer became undetectable at a microscopic level after intensive treatment blocks had a reported three-year event-free survival of 88.9%, compared with 25.0% for those in whom the cancer remained detectable. For the very high-risk T-LLy subgroup who did not respond to intensive treatment, the reported event-free survival figure was 0%. It is worth noting that the number of participants recorded as "completed" in the data is lower than those who started — the reported data does not fully explain the reasons for all participants not completing the study protocol. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03106779 · results posted 15 February 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT03106779) compared two medicines — asciminib and bosutinib — in people with a type of blood cancer called chronic myeloid leukaemia (CML). A total of 233 people joined the trial: 157 were assigned to the asciminib group and 76 to the bosutinib group. The trial's main goal was to measure how many participants in each group reached a specific milestone called "major molecular response" (MMR) by 24 weeks — this means the amount of a particular cancer-related signal in the blood had fallen to a very low level, as measured by a laboratory test. The reported data shows that, at the 24-week mark, 40 out of 157 participants in the asciminib group and 10 out of 76 participants in the bosutinib group reached that MMR milestone. In terms of how many people finished the full study period, 97 participants in the asciminib group and 22 in the bosutinib group completed it; 60 and 54 respectively did not complete it. The trial also planned to measure several other things — such as how long MMR lasted, how quickly it was reached, and a separate measure called "complete cytogenetic response" — however, the results for all of those secondary outcomes were not reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00038675 · results posted 4 January 2022

    According to the results reported on ClinicalTrials.gov, this trial enrolled 125 participants, all of whom received a medicine called imatinib mesylate. All 125 participants completed the study. The trial was looking at how many people with certain blood and bone marrow conditions — including acute myeloid leukaemia (AML), myelodysplastic syndromes (MDS), and several other related conditions — experienced what researchers call a "complete response." A complete response means the signs and measurements of the disease returned to normal levels based on specific criteria set for each condition. The reported data shows that the number of participants recorded as having a complete response varied across the different disease groups included in the trial. The figures reported were: 0, 0, 2, 0, 3, 4, 0, 1, and 2 participants respectively across the different disease subgroups measured — though the data as submitted does not clearly label which number corresponds to which specific condition for each measurement. The overall numbers of complete responses were small across all groups. For the secondary outcomes, the reported data shows that among those who did have a response, the duration of that response — meaning how long the response lasted — was reported as 68 months. Overall survival — meaning the time from entering the study until disease progression or death from any cause — was reported as 73.2 months. It is important to note that these figures represent what was measured and recorded in this specific group of participants, and the data was not broken down further by disease type for these measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02339740 · results posted 16 December 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT02339740) enrolled 158 people with a type of blood cancer called acute promyelocytic leukaemia (APL). Participants were divided into two groups based on how their disease was classified at diagnosis: 101 people in the "Standard Risk" group and 57 in the "High Risk" group. The trial was measuring something called "event-free survival" — that is, the percentage of participants who, over a two-year period, did not experience certain setbacks such as the cancer not responding to initial treatment, signs of remaining disease after further treatment, the cancer coming back, or death. The reported data shows that, among the Standard Risk group, the estimated two-year event-free survival figure was 97.9% of participants. For the High Risk group, the reported figure was 96.1% of participants. In plain terms, these numbers represent the proportion of people in each group who had not experienced any of those defined setbacks by the two-year mark, based on a statistical estimation method (a standard way of calculating survival figures over time called the Kaplan-Meier method). A number of other planned measurements — including comparisons based on specific gene changes, disease-free survival, rates of serious bleeding or clotting events, and cognitive test scores — were listed in the trial's design but no results data for those outcomes was reported in the structured data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01889186 · results posted 16 December 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 158 people in total — 107 in a "Main Cohort" and 51 in a "Safety Expansion Cohort." The trial was looking at two main things: how often participants with chronic lymphocytic leukaemia (a type of blood cancer) showed a measurable response to the study treatment, and how many participants in the Safety Expansion group experienced any unwanted medical events (called adverse events) during the study. It is worth noting that the data shows zero participants recorded as having "completed" the study in the formal tracking, meaning all participants were counted under "not completed" — which may reflect how the trial's completion was defined rather than all participants dropping out. The reported data shows that in the Main Cohort, 77.1% of the first 70 participants assessed showed some form of response (meaning their disease met certain criteria for improvement, ranging from partial to complete remission). In the Safety Expansion Cohort, the reported response rate was 82.4%. Breaking this down further, the reported data shows that complete remission (the deepest level of response measured) was recorded in 21.5% of Main Cohort participants and 27.5% of Safety Expansion participants, while partial remission was recorded in 53.3% and 54.9% respectively. For how long responses lasted, the Main Cohort showed a reported median duration of 35.3 months; this figure was not reported for the Safety Expansion Cohort. Regarding adverse events in the Safety Expansion Cohort, all 51 participants were recorded as having experienced at least one adverse event, though the data as submitted does not break down the nature or severity of those events further. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00774345 · results posted 2 December 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT00774345) enrolled 317 people in total — 160 in the lenalidomide group and 157 in the placebo group — before the treatment phase began. The trial was measuring how long participants lived overall (called "overall survival"), how long it took for their condition to get worse for a second time ("progression-free survival 2"), and how many participants experienced unwanted health events (called "adverse events") during the study. The reported data shows that, for overall survival, the lenalidomide group had a median figure of around 95 months, compared with around 73 months in the placebo group. A "median" here simply means the midpoint — half the people in each group survived longer than that figure, and half did not reach it. For the second measure — the time until a second worsening of the condition — the reported data shows a median of approximately 35.9 months for the placebo group; a corresponding figure for the lenalidomide group was not reported in the data. Regarding adverse events, the reported data shows that 155 of 158 lenalidomide participants and 149 of 157 placebo participants experienced at least one adverse event of any kind. More severe adverse events (graded 3–4, meaning more serious) were reported in 136 lenalidomide participants compared with 73 placebo participants. Adverse events considered related to the study drug were reported in 143 lenalidomide participants versus 98 placebo participants, and severe drug-related events in 117 versus 41 participants respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01404949 · results posted 30 November 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 17 participants, all of whom received a combination of two medicines — tretinoin and arsenic trioxide (with an additional medicine called idarubicin given to those whose disease was considered higher risk or who developed a high white blood cell count during treatment). The trial was studying a type of blood cancer called acute promyelocytic leukaemia (APL). It set out to measure things like how many patients achieved a "molecular remission" (meaning no detectable cancer could be found using very sensitive laboratory tests), how long patients stayed free of disease, and what side effects occurred. Of the 17 people who started the trial, 16 completed it and 1 did not. The reported data shows that for the primary outcome — the rate of molecular remission after the initial treatment phase — no numerical results were submitted to ClinicalTrials.gov, so those figures are not available. For several other planned measurements, including the proportion of patients in molecular remission after later treatment courses, disease-free and event-free survival, toxicity details, and laboratory studies of cancer cell changes, the data was also not reported. The one secondary outcome that does include a number shows that 16 out of 17 participants were reported to have achieved a "complete remission" — meaning their cancer was no longer detectable by standard tests — after the initial treatment phase. It is worth noting that because most of the planned outcome data was not submitted, the picture from this trial is incomplete based on what is publicly available. The reported data shows only a small snapshot of what the trial was designed to measure, and the small number of participants (17 people) means these figures relate to a very specific and limited group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02545283 · results posted 14 September 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT02545283) enrolled 447 people with a form of blood cancer called acute myeloid leukaemia (AML) that had either come back or stopped responding to earlier treatment. Participants were randomly assigned to receive either a chemotherapy medicine called cytarabine combined with an investigational drug called idasanutlin (298 people), or cytarabine combined with a placebo — a dummy treatment with no active ingredient (149 people). The main thing the trial was measuring was how long participants in a specific subgroup (those whose tumours had a normal, unaltered version of a gene called TP53) lived overall. Importantly, the trial was stopped early because an independent review concluded it was unlikely to show a meaningful difference between the two groups — a process known as "futility stopping." The reported data shows that, among the TP53 subgroup, the median overall survival — meaning the point at which half the participants in each group had passed away — was reported as 9.13 months in the placebo-plus-cytarabine group and 8.28 months in the idasanutlin-plus-cytarabine group. For the secondary measures, the reported data shows that 20.3% of the placebo group and 17.1% of the idasanutlin group achieved a complete response (meaning no detectable signs of leukaemia) by the end of the initial treatment phase. The time participants went without their disease worsening or dying (called event-free survival) was reported as 6.29 weeks in the placebo group and 4.36 weeks in the idasanutlin group. Overall remission — a broader measure that includes partial recoveries as well as complete responses — was reported in 38.8% of the placebo group and 22.0% of the idasanutlin group. Among those who achieved a complete response, the median time before the disease returned was 18.73 months in the placebo group and 16.76 months in the idasanutlin group, though the trial was cut short before these figures were fully established. Roughly similar proportions in each group (10.6% placebo vs 11.6% idasanutlin) went on to receive a stem cell transplant after achieving complete response. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01700673 · results posted 2 September 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 25 people in total across three treatment groups: 23 participants received a non-myeloablative bone marrow transplant (a type of stem cell transplant using lower-intensity preparation), 1 received a myeloablative bone marrow transplant (a higher-intensity preparation), and 1 received standard consolidation chemotherapy. All participants had either acute myeloid leukaemia (AML) or myelodysplasia (MDS) considered to be high risk, and were given a combination of two medicines — azacitidine and sargramostim — as maintenance treatment during remission. The trial was measuring how many participants remained free of their disease returning over one and two years, as well as how many were still alive at two years and how many experienced a drop in red blood cells (anaemia). The reported data shows that for the primary measure — the number of participants who were free from disease relapse at two years — 8 out of 23 people in the non-myeloablative transplant group, 1 out of 1 in the myeloablative transplant group, and 1 out of 1 in the standard chemotherapy group met this measure. For the one-year relapse-free survival, the reported numbers were 12, 1, and 1 respectively across the three groups. For overall survival at two years, the reported data shows 6 participants in the non-myeloablative group, 1 in the myeloablative group, and 1 in the standard consolidation group. Regarding anaemia as a reported side effect, the numbers recorded were 8, 1, and 0 across the three groups. It is important to note that with only 25 participants total — and just one person each in two of the three groups — the numbers reported are very small, which makes it difficult to draw broad conclusions from them. The reported data shows what was observed in this particular group of people in this trial setting only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00449761 · results posted 14 July 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 27 participants, all of whom received a treatment called panobinostat. The trial was measuring how many people had a "hematologic response" — meaning meaningful improvements in their blood cell counts and disease markers — in people with a form of blood cancer. Of the 27 who started, 9 completed the study and 18 did not complete it (the reasons for this were not detailed in the data provided here). The reported data shows that for the main (primary) outcome — the number of participants who had a hematologic response — the result was zero out of 27 participants. In other words, none of the participants met the criteria for a meaningful blood response as defined by the trial. For all of the secondary outcomes, which looked at things like how long any response lasted and whether participants showed improvements at the chromosome level in their cancer cells (cytogenetic responses), no numerical results were reported in the data submitted to ClinicalTrials.gov. Because the secondary outcome numbers were not reported, it is not possible to describe what those measurements found. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03451084 · results posted 2 July 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT03451084) tested a medicine called ASLAN003 in 24 people with acute myeloid leukaemia (a type of blood cancer). Participants were split into four groups of six, each receiving a different dose: 100 mg once daily, 200 mg once daily, 100 mg twice daily, or 200 mg twice daily. The trial was measuring whether participants achieved remission (where signs of leukaemia become very low or undetectable in the blood and bone marrow), as well as tracking any unwanted events (called adverse events) that occurred during the study. Notably, none of the 24 participants completed the study — all 24 are recorded as having not completed it, though the data does not explain why for each individual. The reported data shows that for the primary goal of complete remission, no participants in any of the four groups achieved this outcome. Regarding adverse events (unwanted health events that occurred during the study period), the numbers reported were: 5 out of 6 participants in the 100 mg once-daily group, 6 out of 6 in the 200 mg once-daily group, 6 out of 6 in the 100 mg twice-daily group, and 6 out of 6 in the 200 mg twice-daily group. For laboratory test findings (blood and chemistry tests), the reported data shows varying numbers across groups, ranging from 0 to 3 participants per group with notable findings. For a secondary measure — the percentage change in leukaemia cells in the bone marrow at day 29 — figures were only reported for two of the four groups: a reduction of approximately 34% in the 100 mg once-daily group and approximately 8% in the 200 mg once-daily group. The remaining two groups' figures were not reported in the data. The other secondary outcome measures (relapse-free survival and clinical benefit rate) had no numerical results reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00171158 · results posted 25 June 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 260 people, all of whom received a medicine called Imatinib Mesylate (also known as STI571). The trial was measuring overall survival — that is, how many participants were still alive over the course of the study, and for how long. Of the 260 people who started the main part of the trial, 21 completed it, while 239 did not complete it (the reasons for this are not detailed in the reported data). A smaller follow-on extension phase involved 8 participants, of whom 1 completed that stage. The reported data shows two ways of looking at overall survival. First, a single overall figure: 89.2% of participants experienced a death event during the study period — meaning that figure represents the proportion of participants who had died, not survived, by the end of the observation period. Second, the data shows survival estimates tracked month by month using a standard statistical method (called Kaplan-Meier, which estimates the share of people still alive at each point in time). The reported data shows that at the earliest recorded time point, approximately 32.7% of participants were still alive, and this figure declined over subsequent time points, reaching 7.5% at several later points and 5.5% at the final two time points reported. The exact months these figures correspond to were not included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03416179 · results posted 25 June 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT03416179) enrolled 729 adults across two separate studies looking at a drug called glasdegib in people with a type of blood cancer. The "intensive study" compared 201 people receiving glasdegib plus two standard chemotherapy medicines (cytarabine and daunorubicin) against 203 people receiving a placebo plus the same chemotherapy. The "non-intensive study" compared 163 people receiving glasdegib plus another medicine (azacitidine) against 162 people receiving a placebo plus azacitidine. Both studies measured overall survival — that is, how long participants lived from the time they were randomly assigned to a treatment group. The reported data shows that in the intensive study, the median overall survival (the point at which half the participants in each group had died) was 17.3 months for the glasdegib group and 20.4 months for the placebo group. In the non-intensive study, median overall survival was 10.3 months for the glasdegib group and 10.6 months for the placebo group. The trial also measured the proportion of participants whose fatigue scores improved on a standard questionnaire: in the intensive study, roughly 17.4% of the glasdegib group and 17.2% of the placebo group showed improvement; in the non-intensive study at 12 weeks, approximately 11.7% of the glasdegib group and 15.4% of the placebo group showed improvement. A further measure looked at the percentage of participants who achieved a very deep remission (no detectable signs of disease): in the intensive study this was 5.0% (glasdegib) versus 5.4% (placebo), and in the non-intensive study 1.8% (glasdegib) versus 0.6% (placebo). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00914628 · results posted 22 June 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT00914628) enrolled a total of 92 participants who had undergone a bone marrow or blood stem cell transplant. They were divided into two groups: 64 people in the experimental treatment arm and 28 people in the control (comparison) arm. The trial was measuring several things, most importantly "disease-free survival" — meaning how long participants went without their disease returning or worsening — as well as overall survival, immune system recovery, and rates of a complication called graft-versus-host disease (where the transplanted cells can react against the recipient's body). The reported data shows that for the main measure, disease-free survival, numbers of participants were tracked across several categories, though the exact time-point breakdowns are not fully labelled in the submitted data. Across the experimental arm, figures such as 45, 19, 25, 13, 38, and 17 participants were recorded across the reported categories; in the control arm the corresponding figures were 20, 8, 18, 8, 20, and 8. For overall survival, the reported participant counts in the experimental arm were 22, 42, 14, 24, 20, and 35, while the control arm recorded 10, 18, 10, 16, 10, and 18. For immune recovery — measured by whether a type of immune cell called CD3+ cells reached a sufficient level in the blood — the reported data shows counts of 38, 13, 6, 1, 29, and 4 participants in the experimental arm, and 22, 5, 1, 0, 22, and 3 in the control arm. No numerical results were reported on ClinicalTrials.gov for engraftment rate or for either form of graft-versus-host disease. It is worth noting that the submitted data records zero participants as having "completed" the study in either group, and the specific labels for each participant count (for example, which time points or sub-categories they refer to) are not fully detailed in the data as submitted. This means the numbers above cannot be fully interpreted without the complete study report. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02467270 · results posted 14 June 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT02467270) enrolled 283 adults across three groups, each receiving a different daily dose of a medicine called ponatinib — 45 mg (94 people), 30 mg (95 people), or 15 mg (94 people) — over a treatment period of up to 60 months, followed by an 11-month close-out period. The trial was measuring how well each dose reduced the level of a specific abnormal gene signal in the blood (called BCR-ABL), which is linked to a type of leukaemia. The main goal was to see how many participants in each group reached a particular level of reduction in that signal by 12 months. The reported data shows that, at the 12-month mark, 44.1% of participants in the 45 mg group, 29.0% in the 30 mg group, and 23.1% in the 15 mg group reached the primary target level of gene-signal reduction. For a deeper level of reduction (known as a major molecular response), the reported figures at one measured timepoint were 17.2%, 20.4%, and 16.5% respectively, rising to 46.2%, 29.0%, and 24.2% at a later timepoint. The trial also looked at a measure called major cytogenetic response — essentially a change detected in bone marrow cells — with 48.4%, 30.0%, and 43.8% of participants in the three groups respectively reaching that marker. The data on how long the molecular response lasted was not reported for any group. The reported data also tracked certain medical events that occurred during the trial. Arterial blockage events (such as those affecting the heart or blood vessels) were recorded in 13.8%, 9.6%, and 5.3% of participants in the 45 mg, 30 mg, and 15 mg groups respectively during the treatment period. Vein-related clotting events were reported in 1.1% across all three treatment-period groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02756572 · results posted 22 March 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 30 participants who received chemotherapy (a regimen called G-CLAM) followed by a stem cell transplant from a donor (called an allogeneic haematopoietic cell transplant, or HCT). All 30 participants completed the study. The trial was mainly trying to find out whether it was practical ("feasible") to offer this type of transplant early — within 60 days of starting treatment — and whether patients who received an early transplant were still free of their disease six months later. The reported data shows that, of the 30 participants enrolled, 9 received the transplant within the 60-day window defined as "early," while 21 did not. The pre-set target for the trial to be considered feasible on this measure was for at least 15 out of 30 participants to receive an early transplant, so the reported number of 9 fell below that target. For the second main measure — survival free of disease at six months among those who did receive an early transplant — the reported data shows 6 out of 8 participants in that group met this outcome, and 2 did not. Among the smaller group who received the transplant on study, response assessments at day 28 showed 7 participants had a complete remission with incomplete blood count recovery (CRi), and 1 had detectable remaining disease; by day 84, 4 participants were in CRi, 2 had detectable remaining disease, and 2 had experienced a relapse. The reported data also shows relapse-free survival figures of 91% at one time point and 82% at another for those who received the early transplant, though the specific time points these figures correspond to were not clearly distinguished in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02293993 · results posted 5 March 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 21 participants across four groups (called cohorts): 4 people in Cohort 1, 6 in Cohort 2, 7 in Cohort 3, and 4 in Cohort 4. The trial was testing a drug called SGI-110 (also known as guadecitabine) and was primarily looking at whether certain serious side effects — referred to as "dose-limiting toxicities" or DLTs — occurred during the first round of treatment. It was also tracking how the drug and one of its breakdown products (called decitabine) moved through the body at different doses and time points. The reported data shows that, for the primary outcome, only 1 participant out of the 21 experienced a dose-limiting toxicity, and that was in Cohort 3. No DLTs were reported in Cohorts 1, 2, or 4. For the secondary outcomes, the trial measured how much of the drug reached the bloodstream, how quickly it peaked, and how long it stayed in the body. To give a few examples of the reported numbers: the peak blood concentration of SGI-110 on the first day of treatment ranged from 96.8 ng/mL in Cohort 1 up to 359 ng/mL in Cohort 4, broadly in line with the different doses given. The drug appeared to reach its peak level in the blood within roughly 1 to 1.5 hours across all cohorts, and its half-life (the time it takes for half the drug to leave the body) was under one hour for SGI-110, while its active breakdown product decitabine took slightly longer, around 1 to 1.1 hours in most cohorts. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02348489 · results posted 14 January 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 815 adults in total — 408 received an experimental drug called SGI-110 (also known as guadecitabine), and 407 received a "treatment choice" selected by their doctor from existing options. The trial was studying people with acute myeloid leukaemia (a type of blood cancer) and was primarily measuring two things: how many participants achieved a complete response (meaning no detectable signs of the cancer by standard criteria), and how long participants survived overall. The reported data shows that, for the first primary measure — complete response — 79 out of 408 participants in the SGI-110 group and 71 out of 407 in the treatment choice group met that standard. For the second primary measure — overall survival — the reported median survival (the point at which half the participants had died) was 213 days for the SGI-110 group and 254 days for the treatment choice group. On the secondary measures, the reported data shows that a broader measure of response (including partial blood-count recovery) was seen in 93 participants on SGI-110 and 91 on treatment choice. The median number of days participants were alive and out of hospital over six months was reported as 98.1 days for SGI-110 and 105.7 days for treatment choice. Progression-free survival (the time before the disease worsened or another treatment was needed) was reported as a median of 159 days for SGI-110 and 166 days for treatment choice. Average numbers of blood and platelet transfusion units were also reported and were broadly similar between the two groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01698905 · results posted 13 January 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT01698905) enrolled 163 people and followed them through several study phases. The trial was looking at what happens when people with a type of blood cancer (chronic myeloid leukaemia) who had been taking a medicine called nilotinib stopped taking it — a concept called "treatment-free remission" (TFR), meaning staying in remission without continuing medication. Of the 163 who started, 126 entered the phase where they stopped taking nilotinib, 152 completed the study overall, and 11 did not complete it. The reported data shows that the main thing being measured was the percentage of participants who remained in TFR — meaning their disease stayed at a very low, stable level with no need to restart nilotinib — within the first 48 weeks after stopping the medicine. According to the results reported on ClinicalTrials.gov, 57.9% of those who entered the treatment-free phase met this measure at the 48-week mark. For the secondary outcomes — which included longer-term TFR rates at 96 weeks and beyond, survival measures, and changes in a specific gene marker (BCR-ABL) in those who restarted nilotinib — the reported data shows that no numerical results were submitted for these measures on ClinicalTrials.gov, so those figures cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01827930 · results posted 31 December 2020

    According to the results reported on ClinicalTrials.gov, this trial involved 68 people in total. Twenty-four participants were randomly assigned to receive a 600 mg daily dose of imatinib, 25 were randomly assigned to receive a 400 mg daily dose, and a separate non-randomised group of 19 people also received 400 mg daily. All 68 participants completed the study. The trial was measuring changes in a specific genetic marker in the blood called BCR-ABL — a signal linked to a type of blood cancer — using a sensitive laboratory test at the start of the study and then at 3, 6, 9, and 12 months. The main goal was to see what proportion of participants showed a meaningful reduction in that marker by 12 months. The reported data shows that, for the primary outcome at 12 months, 29.2% of participants in the 600 mg randomised group and 32.0% in the 400 mg randomised group met the study's pre-set target for a reduction in the BCR-ABL marker. In the separate 400 mg non-randomised group, 10.5% met that target. For one of the secondary outcomes — a much larger reduction (described in the study as a "2-log" drop, meaning the marker fell to one-hundredth of its starting level) — the reported data shows this was seen in only 4.2% of the 600 mg group at certain time points and 0% in both 400 mg groups across all time points. Regarding another secondary measure, a "major molecular response" (marker at or below 0.1%) was reported in 87.5% of the 600 mg group and 72.0% of the 400 mg randomised group by 12 months. The reported median time to the first undetectable BCR-ABL result was 8.7 months in the 600 mg group and 3.2 months in the 400 mg randomised group; the non-randomised cohort data was not reported for some of these measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01720225 · results posted 24 December 2020

    According to the results reported on ClinicalTrials.gov, this trial compared two treatments — decitabine and azacitidine — in people with a blood or bone marrow condition. A total of 73 people were enrolled in the decitabine group and 40 in the azacitidine group, with 70 and 39 people respectively completing the study. The trial was primarily measuring how many participants showed a response to treatment, which was defined as achieving one of several levels of improvement in blood counts and bone marrow findings — ranging from a full remission through to more modest improvements in blood cell levels. The reported data shows that, in the decitabine group, 49 out of 73 participants met the criteria for a response. In the azacitidine group, 19 out of 40 participants met those same criteria. For the secondary outcome, the trial also looked at how many participants who had been relying on regular blood transfusions before the study went at least eight consecutive weeks without needing one during treatment. The reported data shows that 12 participants in the decitabine group and 3 participants in the azacitidine group reached that threshold of transfusion independence. It is important to note that these figures describe what was counted and measured in this particular trial — they do not on their own tell us whether one treatment is better than another, and no conclusions about individual suitability should be drawn from them. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01757535 · results posted 6 November 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT01757535) enrolled 472 adults with acute myeloid leukaemia (AML) who had achieved remission after initial treatment. Participants were randomly assigned to receive either oral azacitidine plus best supportive care (238 people) or a placebo plus best supportive care (234 people). The trial was measuring how long people lived overall, how long they went without their disease returning, and other related time points. The reported data shows that the estimated median overall survival — that is, the point at which half the participants in each group had died — was 24.7 months in the oral azacitidine group compared with 14.8 months in the placebo group. For relapse-free survival (the time before the disease came back or a person died, whichever came first), the reported median was 10.2 months in the oral azacitidine group and 4.8 months in the placebo group. The reported median time to relapse alone was 10.2 months versus 4.9 months, and the median time participants stayed on their assigned treatment was 14.6 months versus 6.9 months. On a fatigue questionnaire scored from 0 to 52 (higher scores meaning less fatigue), both groups reported a small decline from their starting score: minus 3.7 points in the oral azacitidine group and minus 2.5 points in the placebo group. Regarding side effects, the reported data shows that 235 of 236 treated participants in the oral azacitidine group and 233 of 233 in the placebo group experienced at least one treatment-emergent adverse event (an unwanted health event occurring during or shortly after treatment). Serious adverse events were reported in 113 people in the oral azacitidine group and 55 in the placebo group. Grade 3 or higher events — meaning severe or life-threatening reactions as classified by a standard medical scale — were reported in 22 people in the oral azacitidine group and 5 in the placebo group, though full breakdowns of all adverse event categories were not detailed further in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01483690 · results posted 27 October 2020

    According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 23 participants, split into two groups: 5 people in an "Initial Dose Level" group and 18 people in a "Modified Dose Level" group. The trial was looking at the side effects of combining two drugs — decitabine and vorinostat — alongside a standard chemotherapy regimen (vincristine, dexamethasone, PEG-asparaginase, and mitoxantrone) in people with leukaemia. Of those who started, 3 people in the initial dose group and 13 in the modified dose group completed the study. The reported data shows that the primary thing being measured was how many participants experienced what researchers call a "dose limiting toxicity" (DLT) — meaning a serious side effect severe enough that it would limit how much of the drug could be given. According to the results reported on ClinicalTrials.gov, 2 out of 5 participants in the Initial Dose Level group and 1 out of 18 in the Modified Dose Level group experienced a DLT. For the secondary outcome, the trial measured how participants' disease responded to treatment, assessed at Day 35. The reported data shows that across both groups, no participants in the initial dose group and 1 in the modified dose group achieved a complete response (cancer undetectable with full blood count recovery). Partial or near-complete responses of varying types were also recorded across both groups, while 2 participants in the initial dose group and 7 in the modified dose group did not meet the criteria for any level of response. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03206918 · results posted 25 September 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT03206918) enrolled 91 participants, all of whom received the drug zanubrutinib. The trial was looking at how people with certain types of blood cancer (chronic lymphocytic leukaemia or small lymphocytic lymphoma) responded to this treatment. Notably, the data shows that none of the 91 participants were recorded as having "completed" the study in the formal sense — all 91 were listed under "not completed," which may reflect the ongoing nature of follow-up at the time the data was submitted, though no further explanation for this was reported. The reported data shows that, based on an independent review panel, 80 out of 91 participants achieved a measurable response to treatment (this is called the Overall Response Rate, or ORR — meaning their disease showed signs of change by a set definition). When the treating doctors made their own assessments, the reported response rate was 92.3% of participants. For the measure of how long participants went without their disease getting worse or dying (called progression-free survival), the reported figures at four different time points were 93.3%, 88.7%, 80.5%, and 68.1% of participants remaining event-free — though the specific time points for these figures were not included in the submitted data. Among those who did respond, the reported data shows that 97.5%, 92.5%, 83.4%, and 69.9% remained in response at the same series of time points. The reported median time from the start of treatment until a first response was recorded was approximately 2.79 months. For the measure tracking unwanted medical events (called adverse events — meaning any health problem that occurred during the study period, whether or not linked to the drug), the reported data shows that 90 out of 91 participants experienced at least one such event. Various breakdowns of these events were reported — for example, 76 participants, 47 participants, 6 participants, 14 participants, 42 participants, 42 participants, and 8 participants fell into different categories of adverse events — however, the labels describing what each of those specific numbers represents were not included in the submitted data, so a more detailed breakdown cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02281084 · results posted 8 July 2020

    According to the results reported on ClinicalTrials.gov, this trial enrolled 65 people in total across four groups, all of whom had a blood condition called myelodysplastic syndrome (MDS). Thirty-two participants whose disease was stable received oral azacitidine alone, 22 whose disease was progressing received oral azacitidine alone, six with stable disease received oral azacitidine combined with durvalumab, and five with progressing disease received the combination. The trial was measuring how many participants showed a blood cell response to treatment, how long participants lived, and how long it took for their disease to get worse. The reported data shows that the main outcome — the proportion of participants whose blood counts improved or whose disease responded — was 6.3% in the stable disease/azacitidine-alone group, 4.5% in the progressing disease/azacitidine-alone group, 16.7% in the stable disease/combination group, and 0% in the progressing disease/combination group. For overall survival (the time from starting treatment until death from any cause), the reported median figures were 17.0 months for stable disease/azacitidine alone, 6.28 months for progressing disease/azacitidine alone, 14.7 months for stable disease/combination, and 14.56 months for progressing disease/combination. The reported median time until disease worsening (progression-free survival) was 14.86, 6.28, 14.70, and 12.10 months for those same four groups respectively. For how long responses lasted, the data was not reported for most groups. It is worth noting that the combination groups were very small (six and five participants), so the numbers from those groups reflect very few people. The reported data shows that only a small number of participants completed the full study across all groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗

  • NCT01371981 · results posted 7 July 2020

    According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 1,645 participants across six treatment groups (called Arms A, B, C, and D). Arm A had 580 participants, Arm B had 591, Arm D had 382, and Arms C (split into three smaller sub-groups called cohorts) had 12, 33, and 47 participants respectively. The trial was measuring outcomes in people with a type of leukaemia, focusing on two main things: "event-free survival" (EFS — meaning the proportion of patients who had not experienced treatment failure, relapse, a second cancer, or death) and "overall survival" (OS — the proportion of patients still alive) at the three-year mark. The reported data shows the following three-year EFS figures (the percentage of patients in each group who had not experienced one of those setbacks): Arm A — about 45.6%; Arm B — about 47.0%; Arm C Cohort 1 — 25.0%; Arm C Cohort 2 — about 56.1%; and Arm C Cohort 3 — about 58.2%. For three-year overall survival, the reported data shows: Arm A — about 65.0%; Arm B — about 68.5%; and Arm C Cohort 1 — about 41.7%. Overall survival figures for Arm C Cohorts 2 and 3, and for Arm D, were not reported in the submitted data. Of those who started the trial, roughly two-thirds of participants in the larger arms completed it, while completion rates were lower in the smaller Arm C cohorts. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00462761 · results posted 24 April 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT00462761) enrolled 76 people who had a type of blood cancer called acute myeloid leukaemia (AML) that had either returned after previous treatment or had stopped responding to it. All 76 participants received an oral (taken by mouth) medicine called quizartinib, tested across a range of different doses. The trial's main focus was on recording unwanted side effects that appeared during treatment and were thought to be related to the study drug — what researchers call "treatment-related adverse events." None of the 76 participants were recorded as having formally "completed" the study, which is common in early-phase trials of this kind where the primary aim is to understand how a drug behaves at different doses rather than to measure a long-term outcome. The reported data shows that, across all participants, 39 experienced at least one treatment-related side effect of any kind. When looking specifically at more severe side effects (graded 3 or 4, meaning more serious in nature), the numbers varied by dose group: 6 out of those receiving lower doses (12–135 mg, one dosing schedule), 3 out of those on a higher dose range (200–450 mg, same schedule), and 3 out of those on a different dosing schedule (200–300 mg), giving a total of 12 participants across all groups with these more serious side effects. For the secondary outcomes — which tracked how participants' disease responded across the different dose levels — the reported data shows that the number of participants recorded as achieving the best overall response (including various categories of remission or partial remission) ranged from 0 to 6 depending on the dose group. The number whose disease was recorded as progressing (getting worse) also varied by dose group, ranging from 0 to 4. A full breakdown for every individual dose group and response category was reported but the total figure across all participants for these secondary measures was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03069352 · results posted 28 February 2020

    According to the results reported on ClinicalTrials.gov, this trial enrolled 211 adults with a type of blood cancer called acute myeloid leukaemia (AML). Participants were randomly assigned to one of two groups: 68 people received a placebo (an inactive dummy treatment) plus a low-dose chemotherapy called low-dose cytarabine (LDAC), while 143 people received a medicine called venetoclax plus the same low-dose chemotherapy. The main thing the trial was measuring was overall survival — that is, how long participants lived from the time they joined the trial. The reported data shows that, on average, participants in the placebo plus LDAC group lived for 4.1 months from the time they were enrolled, while participants in the venetoclax plus LDAC group lived for 7.2 months on average. These figures were calculated using a standard statistical method called Kaplan-Meier, which estimates survival over time across the whole group. The trial also tracked how many participants showed a strong reduction in cancer signs (called "complete remission") or a near-complete reduction (with some blood count values still below normal). The reported data shows that across all remission measures, the percentages were higher in the venetoclax group — for example, 47.6% of the venetoclax group showed a complete or near-complete remission at some point during the study, compared with 13.2% in the placebo group. For full complete remission alone, the figures were 27.3% versus 7.4%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01629511 · results posted 10 February 2020

    According to the results reported on ClinicalTrials.gov, this trial looked at different dose levels of a chemotherapy drug called Gemcitabine, given alongside two other drugs (Busulfan and Clofarabine), as a preparatory treatment before an allogeneic stem cell transplant (where a patient receives stem cells donated by another person). The trial tested four different dose levels and aimed to find the highest dose that could be given without causing unacceptable harm, as well as tracking deaths related to treatment within the first 100 days. A total of 15 people took part — 4 at Dose Level 1, none at Dose Level 2, 8 at Dose Level 3, and 3 at Dose Level 4. All participants who started the trial were recorded as having completed it. The reported data shows that, when counting deaths linked to the treatment within 100 days of the transplant, no such deaths were recorded for Dose Levels 1, 2, or 4, and one such death was recorded among participants at Dose Level 3. For overall survival (meaning participants still alive at the time of reporting), the numbers recorded were 3 out of 4 at Dose Level 1, none recorded for Dose Level 2 (as no one was enrolled there), 4 out of 8 at Dose Level 3, and 2 out of 3 at Dose Level 4. The reported data does not include a specific number for the maximum tolerated dose outcome, and no figures were reported for progression-free survival (how long participants lived without their disease coming back) or for rates of graft versus host disease (a condition where transplanted immune cells attack the recipient's body). The reported data shows that some information — including the final maximum tolerated dose finding, progression-free survival numbers, and graft versus host disease rates — was not provided in the results submitted to ClinicalTrials.gov, so those figures cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02039726 · results posted 27 January 2020

    According to the results reported on ClinicalTrials.gov, this trial involved 367 people with a type of blood cancer (acute myeloid leukaemia) who were randomly assigned to receive either a medicine called quizartinib (245 people) or a standard salvage chemotherapy treatment (122 people). The trial was primarily measuring how long participants lived overall after joining the study, and also tracked a separate measure called "event-free survival" — meaning how long it was before their disease either failed to respond, came back, or they passed away. The reported data shows that, on average (using a statistical method called Kaplan-Meier, which estimates the midpoint of survival times across the group), participants in the quizartinib group lived for a reported median of 27.0 weeks from the time they entered the trial, compared with 20.4 weeks for those in the salvage chemotherapy group. For the secondary measure — event-free survival — the reported median time before a setback or death was 6.0 weeks in the quizartinib group and 3.7 weeks in the salvage chemotherapy group. These are group-level figures and do not predict what would happen to any individual person. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01565668 · results posted 27 December 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 76 people in total — 38 in a group receiving a 30 mg daily dose of a drug called quizartinib, and 38 in a group receiving a 60 mg daily dose. The trial was measuring responses in people with a type of blood cancer (leukaemia), looking at whether their disease showed signs of remission (a reduction or disappearance of cancer cells in the bone marrow) and how long participants survived or remained free of disease progression. Notably, none of the participants were recorded as having "completed" the study in the traditional sense, though most entered follow-up phases. The reported data shows that for the main outcome — the number of people who achieved what the researchers called a "composite complete response" (meaning the bone marrow showed very low levels of cancer cells, across three different categories of response) — 18 out of 38 participants in the 30 mg group and 18 out of 38 in the 60 mg group met this measure. For the stricter definition of full remission (complete remission only), the reported numbers were much smaller: 2 participants in the 30 mg group and 1 in the 60 mg group. The reported data shows that for overall survival (measured from when participants joined the trial until death from any cause), the median time was approximately 20.9 weeks in the 30 mg group and 27.3 weeks in the 60 mg group. The median time before a relapse or death occurred (called event-free survival) was reported as 12.0 weeks and 13.7 weeks respectively. For those who had achieved a remission response, the time until relapse or death (leukemia-free survival) was reported as 4.1 weeks and 9.1 weeks. Duration of remission figures were also reported, ranging from approximately 4 to 20 weeks depending on the group and the type of remission measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02557516 · results posted 17 December 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT02557516) involved 22 people in total across two phases. The first phase tested three different dose levels of the study treatment — 1 mg/kg (3 people), 2 mg/kg (6 people), and 4 mg/kg (4 people) — to look at how often serious side-effect-related dose problems (called "dose-limiting toxicities") occurred. The second phase then used the most suitable dose from phase one (2 mg/kg) in a further 9 people. The trial was studying a treatment for a type of blood cancer called chronic lymphocytic leukaemia (CLL), and was measuring things like how many participants showed a full disappearance of disease signs (called a "complete response"), as well as how long any improvement lasted and how long participants lived without their disease getting worse. The reported data shows that in the first phase, no dose-limiting toxicities were recorded in the 1 mg/kg group, one was recorded in the 2 mg/kg group, and two were recorded in the 4 mg/kg group. For complete response — meaning all measurable signs of the disease had disappeared — the numbers reported were: 1 out of 3 participants in the 1 mg/kg group, 1 out of 6 in the 2 mg/kg group, 0 out of 4 in the 4 mg/kg group, and 0 out of 9 in the phase two group. For the broader measure of "best overall response" (which also includes partial responses — where disease signs reduced by more than half), the reported data shows partial responses in 2, 3, 2, and 6 participants across the four groups respectively, along with some confirmed and unconfirmed complete responses in the first two groups. The reported data shows that figures for how long any improvement lasted (duration of remission), how long participants went without their disease getting worse (progression-free survival), and how long participants lived overall (overall survival) were all listed as "not available" — meaning those results were not reported in the submitted data. Very few participants across all groups were recorded as having completed the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02404220 · results posted 2 December 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people in total across four groups, each receiving a different combination of two drugs — entospletinib (ENTO) and vincristine (VCR) — at varying doses. The trial was an early-phase study primarily looking at how often participants experienced what are called "dose-limiting toxicities" (DLTs) — that is, serious side effects severe enough to limit how much of the treatment could be given. It also tracked whether participants' blood cancer (acute lymphoblastic leukaemia) showed signs of remission after the induction (initial treatment) phase. No participant completed the study in the conventional sense, meaning all 30 left the trial before the planned end — likely because the trial was stopped or participants moved on to other care, though the specific reasons are not detailed in the reported data. The reported data shows that, for the primary measure of dose-limiting toxicities, the percentage of participants who experienced a DLT varied by group: 33.3% in the lowest ENTO dose group (200 mg + VCR 0.5 mg), 0% in the ENTO 400 mg + VCR 0.5 mg group, 16.7% in the ENTO 400 mg + VCR 1.0 mg group, and 0% in the highest VCR dose group (ENTO 400 mg + VCR 2.0 mg). For the secondary measures looking at responses after the induction phase, the reported data shows that complete remission rates were 20%, 33.3%, 14.3%, and 0% across the four groups respectively. When a broader definition of "overall response" (including partial responses) was used, the figures were 20%, 33.3%, 28.6%, and 10% across the groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00887926 · results posted 11 September 2019

    According to the results reported on ClinicalTrials.gov, this trial tested a drug called IMC-EB10 (also known as LY3012218) in people with a blood cancer condition. A total of 25 people started the trial, divided into four groups, each receiving a different dose of the drug: 5 mg/kg (3 people), 10 mg/kg (14 people), 20 mg/kg (3 people), or 30 mg/kg (5 people). One person in the 10 mg/kg group did not receive at least one dose of the study drug, and one person in that same group did not complete the trial. The trial was primarily designed to find the highest dose that could be given without too many participants experiencing serious side effects — this is known as the "maximum tolerated dose." The reported data shows that the primary outcome — the maximum tolerated dose — was listed as "not applicable" (NA) in the submitted results, meaning a specific figure for this measure was not reported. For the secondary measures, the trial tracked how the drug moved through the body (known as pharmacokinetics). The peak level of the drug measured in the blood (called Cmax, or maximum concentration) rose with increasing doses: at 5 mg/kg it was reported as 129 and 119 micrograms per millilitre across two time points, at 10 mg/kg it was 254 and 781, at 20 mg/kg it was 896 and 1,520, and at 30 mg/kg it was 927 and 1,770. A separate measure of how much drug was present in the blood over time also increased with dose, ranging from 9,090 at the lowest dose to 77,200 at the highest dose (in units of micrograms × hours per millilitre). One drug-exposure measure during a set dosing window was only reported for the 10 mg/kg group (72,500) and 20 mg/kg group (108,000), with data not reported for the other two groups. The reported data also shows that adverse events (unwanted health changes recorded during the trial) were tracked. In terms of serious adverse events, 1 person in the 5 mg/kg group, 7 in the 10 mg/kg group, 1 in the 20 mg/kg group, and 3 in the 30 mg/kg group were recorded. When all adverse events (serious and non-serious) were counted, the numbers were 3, 11, 3, and 5 participants respectively across the four dose groups. Finally, the trial also looked at whether participants developed antibodies (an immune response) against the drug, but no figures for this outcome were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01125176 · results posted 26 August 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 14 participants, all placed in a single group. The trial was measuring how people with chronic lymphocytic leukaemia (CLL) responded to the study treatment. Researchers tracked whether participants showed a response to treatment (either a complete or partial response), as well as how long any response lasted, how long it took for a response to appear, how long participants went without their disease getting worse, and how long participants lived overall. The reported data shows that 14 people started the treatment phase and 13 completed it, with 1 person not finishing. Of those 13 who moved into the follow-up phase, only 2 completed it, while 11 did not — though the data does not explain why. On the main measure — the number of participants who showed a response to treatment — 12 out of 14 participants were reported to have had a response. For the additional measures, the reported figures were: a median (middle value in the group) of 10 months from the start of treatment until a first response was seen; 48 months from the start of treatment until the disease progressed or a participant died; 70 months from the end of treatment until the disease progressed or a participant died; and 97 months from the start of treatment until death. It is worth noting that this was a very small trial with only 14 participants, so the reported numbers reflect a narrow group of people. The reported data shows what was measured in that specific group, under the conditions of that study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02177812 · results posted 28 June 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT02177812) tested a medicine called GSK2879552 in people with a type of blood cancer (acute myeloid leukaemia, based on the trial context). In Part 1, a total of 41 participants were enrolled across eight different groups, each receiving either different daily doses of GSK2879552 (ranging from 1 mg to 20 mg), a combination of GSK2879552 with another medicine called ATRA, or a higher-dose group for additional monitoring. The trial was primarily measuring how participants responded to the treatment in terms of unwanted medical events, serious medical events, and dose-related problems such as dose reductions, delays, or withdrawals. A planned Part 2 expansion cohort did not enrol any participants, so no data was reported for that group. The reported data shows that all 41 participants in Part 1 experienced at least one adverse event (an unwanted medical occurrence during the trial). Across the groups, the numbers reporting serious adverse events included all participants in the 1 mg group (1 of 1), both in the 2 mg group, all 7 in the 4 mg group, and all 5 in the 8 mg group — though the data as submitted does not provide a complete breakdown of serious versus non-serious events for every group separately. The reported data shows that only 1 participant (in the 12 mg group) met the criteria for a "dose-limiting toxicity" — meaning a side effect severe enough within the first 28 days to potentially cap how much of the medicine could be given. Withdrawals due to toxicities were reported across several groups: 1 participant in the 8 mg group, 4 in the 12 mg group, 2 in the 20 mg group, 4 in the combination group, and 2 in the 20 mg expansion group. One participant in the 20 mg expansion group had a dose reduction or delay. Blood test changes from the starting point were also tracked; the reported data shows varying numbers of participants had changes in their blood chemistry readings across the groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01256398 · results posted 21 May 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 66 people, all of whom received a combination of chemotherapy and transplant treatment. Sixty-five of the 66 participants completed the study, with one person not completing it. The trial was primarily measuring how long participants remained free of their disease after achieving an initial complete response (meaning no detectable signs of disease), and it also tracked a number of other outcomes including overall survival and how participants responded to treatment. The reported data shows that the primary outcome — disease-free survival after achieving a complete response — was approximately 52.6% of patients. For secondary outcomes, the reported data shows that around 98.5% of participants achieved a complete response to treatment. Of those who did achieve a complete response, approximately 66.7% showed no detectable signs of a specific genetic marker (called BCR-ABL, a marker associated with a particular type of leukaemia) in their bone marrow and blood after a course of treatment aimed at protecting the central nervous system. The reported data also shows that 5 deaths occurred during the maintenance therapy phase of the study among those who had achieved a complete response. In terms of time-based measures, overall survival was reported at a median (meaning the midpoint value across all participants) of 55.9 months, while disease-free survival had a reported median of 29.7 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01392989 · results posted 7 May 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 44 participants, all of whom received a treatment called Total Lymphoid Irradiation (TLI) as part of a bone marrow (stem cell) transplant procedure using donor cells. Of those 44, 31 went on to receive infusions of specially prepared immune cells called Cytokine Induced Killer (CIK) cells — donor immune cells that had been grown and activated in a laboratory. The trial was primarily measuring how many participants achieved what is called "full donor chimerism" within 90 days — meaning that more than 95% of a certain type of their immune cells (T-cells) came from the donor rather than themselves. It also tracked survival and a serious transplant complication called graft-versus-host disease (GvHD), where donor immune cells can attack the recipient's body. The reported data shows that, of the 31 participants who received the CIK cell infusions, 6 achieved full donor chimerism by day 90. Regarding survival at two years after the CIK infusion, 16 participants were reported to be alive. For "event-free survival" — meaning staying alive without experiencing disease relapse or severe GvHD — the reported data shows 14 participants in one category and 4 in another, though the breakdown between those two figures is not clearly explained in the submitted data. For GvHD, the reported numbers across different time points (within 100 days and within 1 year) and severity levels were: 9, 11, 3, 5, 6, and 6 participants respectively, though the exact grouping of each figure is not fully detailed in the submitted results. For the measurement of certain immune markers (NKG2D ligands) in bone marrow samples before transplant, no results data was reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01295710 · results posted 20 March 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 254 people who had undergone a stem cell transplant from a donor (called an allogeneic transplant). Of these, 126 received a medicine called US-ATG-F and 128 received a placebo (an inactive treatment). The trial was primarily measuring how many participants either developed a moderate to severe form of a condition called chronic graft-versus-host disease (chronic GVHD — a complication where donated cells attack the recipient's body), or died from any cause. By the end of the study, 48 people in the US-ATG-F group and 78 people in the placebo group had completed the trial as planned. The reported data shows that for the primary measure, 60 out of 126 participants in the US-ATG-F group experienced moderate to severe chronic GVHD or death, compared with 72 out of 128 in the placebo group. For overall survival, the reported data shows 49 deaths occurred in the US-ATG-F group compared with 36 in the placebo group. Looking at additional GVHD-related measures, the trial investigators recorded mild-to-severe chronic GVHD in 18 US-ATG-F participants versus 50 placebo participants; moderate-to-severe chronic GVHD in 13 versus 45; and severe chronic GVHD in 3 versus 16. For a related but different complication called acute GVHD (which occurs earlier after transplant), 48 participants in the US-ATG-F group and 71 in the placebo group were reported to have experienced it. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02014558 · results posted 20 February 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT02014558) enrolled a total of 260 participants across 13 groups, each receiving different doses of a medicine called gilteritinib — ranging from 20 mg up to 450 mg per day. The trial had two main phases: an escalation phase (where the dose was gradually increased, with 25 participants across seven dose levels) and an expansion phase (where larger groups received selected doses, with 235 participants across six dose levels). The trial was measuring how the drug moved through the body at different doses, and how many participants experienced certain medical events during treatment. The reported data shows that when it came to serious medical events called "dose-limiting toxicities" (unexpected harmful reactions severe enough to potentially cap how high the dose could go), none were recorded in participants receiving 20 mg through 300 mg in the escalation phase, while 2 out of 3 participants were reported at the 450 mg escalation level. In the expansion phase, the reported numbers ranged from 1 participant at the 20 mg level up to 15 participants at the 200 mg level (data for the 300 mg expansion group was not reported in the structured results). Separately, adverse events — meaning any unwanted medical occurrences noticed during the study — were reported in all participants treated across every dose group. The reported data also shows how much of the drug was measured in participants' blood over time, with drug levels generally rising as the dose increased; for example, peak blood concentration in the escalation phase ranged from around 28 ng/mL at 20 mg to around 208 ng/mL at 450 mg, and the time it took to reach that peak was generally between 2 and 6 hours across the different doses. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02011945 · results posted 17 January 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT02011945) enrolled 31 people in total across three groups: 2 participants received dasatinib only, 13 were in Dose Level 1 (dasatinib plus nivolumab at a lower dose combination), and 16 were in Dose Level 2 (dasatinib plus nivolumab at a higher dose combination). The trial was primarily measuring how often participants experienced certain unwanted medical events — known as adverse events (unexpected or harmful health changes) and serious adverse events (those involving hospitalisation, life-threatening situations, or death) — as well as specific changes in blood, liver, and thyroid test results. A key focus was whether any of these events met the threshold of a "dose-limiting toxicity," meaning a reaction severe enough that it would signal the dose was too high to continue safely. The reported data shows that no dose-limiting toxicities were recorded in any of the three groups. For general adverse events, the reported data shows counts across several categories for Dose Level 1 and Dose Level 2 (for example, 8 and 11 adverse events respectively in one category, and 4 and 3 in another), with 1 adverse event recorded in the dasatinib-only group in one category. For serious adverse events, the reported data shows 3 and 4 events respectively in one category for Dose Level 1 and Dose Level 2, and 4 and 2 in another; no serious adverse events were recorded in the dasatinib-only group in the first category. Notably, no participants in the dasatinib-only group completed the study, while 3 of 13 in Dose Level 1 and 6 of 16 in Dose Level 2 completed it — reasons for not completing were not broken down in the submitted data. The reported data also shows some changes in blood count and thyroid test results. For blood (haematology) tests, shifts to a more severe grade were recorded in up to 5 participants in Dose Level 1 and up to 4 in Dose Level 2 across different measurements, with none in the dasatinib-only group. For thyroid tests, up to 4 incidences of abnormalities were recorded in both Dose Level 1 and Dose Level 2 across different thyroid markers, again with none in the dasatinib-only group. Liver test abnormalities were minimal, with only 1 participant each in Dose Level 1 and Dose Level 2 recording a result outside normal range in one liver measure, and none in any other liver categories reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02019069 · results posted 15 January 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT02019069) enrolled 11 participants, all of whom were treated with a combination chemotherapy drug called CPX-351 (liposomal cytarabine-daunorubicin). All 11 participants completed the study. The trial was primarily measuring the "response rate" — meaning how many participants showed a strong reduction in cancer cells in their bone marrow after treatment, based on specific blood count criteria. The reported data shows that out of 11 participants, 3 met the criteria for a response. Of those 3, 2 achieved what is called a "complete response" (meaning their bone marrow showed less than 5% cancer cells and their blood counts recovered to certain target levels by day 42), and 1 achieved a "complete response with incomplete count recovery" (meaning the bone marrow criteria were met but blood counts did not fully recover to the target levels). For the secondary outcomes, the reported data shows that the median duration of remission — that is, the middle value for how long participants held their response — was 185 days. Regarding survival, 1 out of 11 participants was reported to be alive at 12 months from the time they entered the trial. The reported data also shows that 2 participants died within 30 days of completing the first cycle of treatment. It is worth noting that this was a small study of only 11 people, so the numbers above reflect a very limited group. The reported data shows what was measured in those specific participants under the conditions of this trial, and cannot be assumed to predict outcomes more broadly. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02785900 · results posted 12 December 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT02785900) enrolled 240 people with acute myeloid leukaemia (a type of blood cancer). Participants were randomly assigned to receive either an experimental drug called 33A combined with a hypomethylating agent (a type of chemotherapy medicine), or a placebo (inactive treatment) combined with the same chemotherapy — 117 people in the first group and 123 in the second. The trial was primarily measuring overall survival (how long participants lived) and how many participants achieved a complete remission (where signs of leukaemia could no longer be detected in standard tests). The reported data shows that for overall survival, the 33A plus chemotherapy group had a reported median figure of 5.1 months, while the corresponding figure for the placebo plus chemotherapy group was not reported in the data. For complete remission, 30 participants in the 33A group and 26 participants in the placebo group were reported to have achieved this response. For the secondary outcomes, the reported data shows that 18 participants in the 33A group and 10 in the placebo group achieved remission with no minimal residual disease (meaning no detectable traces of leukaemia by sensitive testing). The reported median duration of remission was 5.1 months for the 33A group and 7.5 months for the placebo group. Event-free survival (time until the disease worsened, returned, or the participant died) was reported as a median of 4.2 months for the 33A group and 6.7 months for the placebo group. Leukaemia-free survival was reported as 5.1 months and 7.5 months respectively. It is worth noting that the data records zero participants as having formally "completed" the trial in either group, which may reflect how trial completion was defined for this particular study rather than meaning no one finished their treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00557193 · results posted 10 December 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 218 infants during the initial treatment phase (called "induction"), of whom 192 completed that phase. After induction, participants were assigned to different treatment groups depending on their individual risk level and a specific genetic feature of their leukaemia (called MLL rearrangement). The trial was measuring how long patients remained free from certain events — such as the leukaemia coming back, a new cancer developing, or death — as well as looking at dosing and blood-level measurements related to an investigational drug called lestaurtinib, which was added to standard chemotherapy in one group. The reported data shows that for the main outcome — the estimated probability of remaining event-free over time — the group receiving chemotherapy plus lestaurtinib at the study's second dose level (Arm C, Dose Level 2) had a reported figure of approximately 35.8%. For comparison, a secondary outcome looked at this same measure in the chemotherapy-only group (Arm B), where the reported figure was approximately 38.9%, versus approximately 35.8% in the lestaurtinib-plus-chemotherapy group. Regarding a specific type of serious side effect linked to lestaurtinib (called a "dose-limiting toxicity" — meaning a reaction severe enough to limit how much of the drug could be given), zero participants experienced this at the lower dose level, and one participant experienced it at the higher dose level. Two other planned measurements relating to drug levels in the blood were not reported in the submitted data. A separate blood-level measurement (called PIA, related to how the drug was acting in the body) had a reported average value of 69%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01824693 · results posted 5 December 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 30 participants in total across three groups. Six people were in Arm I (receiving a combination of busulfan, cyclophosphamide, and melphalan), nine were in Arm II (receiving busulfan and fludarabine phosphate), and 15 were in a separate non-randomised Arm III. The trial was primarily measuring how many participants remained free of certain serious events — such as death related to treatment, graft failure (where the transplanted cells do not take hold), or the return of disease — over an 18-month period after their transplant. The reported data shows that in Arm I, the estimated probability of being free from those events at 18 months was 83%, compared with 22% in Arm II. Regarding deaths related to the treatment within the first 100 days, the reported data shows zero such deaths occurred in Arm I, and one occurred in Arm II. For primary graft failure — meaning the transplanted cells did not establish themselves within 42 days — the reported figure was zero participants in both arms. When looking at the probability of the disease returning by 18 months, the reported figures were 17% for Arm I and 55% for Arm II. It is worth noting that the numbers of participants in each arm were very small (six and nine respectively), and no outcome data was reported for the 15 participants in Arm III. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02130557 · results posted 14 November 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 268 people in the bosutinib group and 268 people in the imatinib group — a total of 536 participants. Both groups had a type of blood cancer called chronic myeloid leukaemia (CML) and had not previously been treated for it. The trial was measuring how well each medication reduced the amount of leukaemia-related signals detectable in the blood and bone marrow, and tracking what happened to participants over several years. The reported data shows that for the main outcome — the proportion of participants showing a specific level of molecular response (a marked drop in leukaemia-related signals in the blood) at 12 months — 47.2% of those taking bosutinib reached that level, compared with 36.9% of those taking imatinib. For the secondary outcomes: by 18 months, 61.0% of the bosutinib group and 52.7% of the imatinib group had reached that same molecular response level. A separate measure looking at bone marrow response by 12 months showed 77.2% in the bosutinib group and 66.4% in the imatinib group. Among those who did achieve these responses, the reported probability of still holding onto them at 48 months was very similar between groups — around 92% for both groups on the molecular measure, and 97.4% versus 93.7% on the bone marrow measure. Finally, the reported cumulative rate of a defined "event" (such as disease worsening or loss of response) by 60 months was 6.9% in the bosutinib group and 10.4% in the imatinib group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02560025 · results posted 11 October 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 42 people, all of whom received a drug called alisertib (also known as MLN8237). Of those 42 participants, 39 completed the study and 3 did not. The trial was primarily measuring how many participants achieved a complete remission — meaning their blood cancer appeared to be in full or near-full retreat based on bone marrow and blood tests — after receiving the study treatment. The reported data shows that out of 42 participants, 20 achieved a full complete remission, and a further 5 achieved what is called a "complete remission with incomplete blood count recovery" (CRi) — a similar result but where certain blood cell counts did not fully recover to the target levels. For the secondary measures, the reported data shows that 50% of participants were still alive at one year. The median duration of remission — that is, the middle-point of how long remission lasted among those who achieved it — was reported as 12.8 months. The median relapse-free survival figure was listed as "NA" (not available), meaning that particular result was not reported in the data. The reported data also shows that 27 out of 42 participants experienced a serious side effect (defined as a grade 3 or higher event considered possibly, probably, or definitely related to the study drug). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02415608 · results posted 20 September 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT02415608) enrolled a total of four people with systemic mastocytosis — a rare condition involving an abnormal build-up of mast cells in the body. Three participants received ibrutinib at a dose of 420 mg per day, and one received 560 mg per day. All four participants completed the study. The trial was primarily measuring the "overall response rate" — that is, how many participants showed a meaningful reduction in disease signs lasting at least 12 weeks, based on specific criteria including mast cell levels, blood counts, and organ-related changes. The reported data shows that none of the four participants — zero in the 420 mg group and zero in the 560 mg group — met the criteria for an overall response. For secondary measures, the reported data shows that all four participants experienced at least one adverse event (an unwanted health event recorded during the study). Regarding changes in mast cell levels in tissue, the 420 mg group showed a median (middle value) reduction of 47%, while the 560 mg group showed no reduction (0%). For a blood marker called serum tryptase, which is used as a surrogate indicator of mast cell activity, the reported median reductions were 30% in the 420 mg group and 50% in the 560 mg group. Pharmacokinetic data (measurements of how the drug moves through the body) were not reported in the submitted results. For a symptom questionnaire scored from 0 (no symptoms) to 270 (worst possible symptoms), the 420 mg group's median score shifted from 56 at the start to 36 at 30 days, while the 560 mg group's median score remained at 41 at both time points. It is worth noting that with only four participants total, this was an extremely small study, and the reported figures reflect a very limited number of people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02546375 · results posted 13 September 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 87 participants, all of whom received the study drug bosutinib. All 87 participants completed the study with none recorded as having dropped out. The trial was designed to measure how participants with chronic myeloid leukaemia (CML) — a type of blood cancer — responded to bosutinib. Researchers looked at two main types of response: haematological response (changes in blood cell counts and spleen size, measured through blood tests) and cytogenetic response (changes in the presence of an abnormal chromosome linked to CML, measured through blood or bone marrow samples). The reported data shows the following percentages of participants who were recorded as achieving each type of response at any point during the study. For blood-count-based responses: 93% of participants reached a complete haematological response (meaning their blood counts and spleen met specific normal-range targets), and 94% reached a partial haematological response. For chromosome-based responses, the reported figures were: 80% reached a minimal cytogenetic response (still a high level of the abnormal chromosome present), 77% reached both a minor and a partial cytogenetic response, and 67% reached a complete cytogenetic response (meaning the abnormal chromosome was no longer detectable). These figures describe the proportions of participants who met each specific, pre-defined measurement threshold during the trial — they do not indicate what any individual participant experienced overall. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01846624 · results posted 7 September 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 13 people who received a combination of two medicines — decitabine followed by midostaurin — for a blood cancer condition. Twelve of the 13 participants completed the study, and one did not. The trial was measuring how many participants achieved a remission (a reduction in cancer markers to defined levels) within 12 months of starting midostaurin, as well as a number of other outcomes including how long any response lasted, and how many participants were still alive or free from worsening disease after two years. The reported data shows that 8 out of 13 participants met the criteria for complete remission (CR or CRi — meaning their disease markers dropped to defined low levels, though in some cases blood cell counts did not fully recover). When partial responses were also counted, the reported data shows that 10 out of 13 participants showed some form of measurable response. Among those who responded, the reported middle ("median") duration of that response was 24 weeks — meaning half of those who responded did so for more or less than 24 weeks. For the longer-term outcomes, the reported data shows that no participants remained free from disease progression or death at two years without having had a stem cell transplant, and 2 out of 13 participants were reported to be alive two years after starting midostaurin treatment. It is important to note that this was a very small trial of 13 people, and the results reflect only what was measured and recorded for this specific group under the conditions of this study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01460160 · results posted 21 August 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 106 participants, all of whom received a treatment combining a medicine called dasatinib with chemotherapy. The trial was designed to measure how many participants remained free of certain serious events — such as the leukaemia not responding, coming back, developing a new cancer, or dying — over time. A total of 78 participants completed the main treatment phase, while 28 did not finish it. The reported data shows that the primary measure — the proportion of participants who had not experienced any of those serious events three years after starting treatment — was 66.0%. For secondary measures, the trial also tracked how many participants achieved what is called a "complete remission" (meaning very low levels of leukaemia cells detectable in the body): this was reported at three different check-in points during treatment, at rates of 65.1%, 88.7%, and 93.4% respectively. Separately, a more sensitive test looking for very tiny traces of leukaemia cells (called minimal residual disease testing) found that 28.3%, 52.8%, and 71.7% of participants tested negative at those same three time points. Longer-term survival estimates using a standard statistical method (which tracks outcomes over time across the group) suggested a three-year event-free rate of 65.5% and a five-year rate of 53.1%. Regarding genetic changes in the cancer that can affect how it responds to dasatinib, 1.3% of participants had a detectable mutation at the start of the trial, and 6.5% had one at the time their disease progressed or returned. All 106 participants were reported as having experienced at least one side effect of any kind, with 88 experiencing a serious side effect, and 7 experiencing a side effect that was fatal. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01971476 · results posted 30 July 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT01971476) tested a drug called volasertib in children and teenagers with leukaemia. A total of 22 young people took part — split into two age groups: children aged 2 to under 12 years (12 participants), and teenagers aged 12 to under 18 years (10 participants). Each age group received one of three different dose levels of volasertib (200, 250, or 300 mg per square metre of body surface area). The main things the trial was measuring were how many participants experienced serious dose-related side effects in the first treatment cycle (called "dose-limiting toxicities"), and what the highest dose was that could be given before those serious side effects became too common. No participants were recorded as having completed the trial — all were listed under "not completed," though the data does not explain the reasons for this in detail. The reported data shows that in the first treatment cycle, no dose-limiting toxicities were recorded in the younger age group (2 to under 12 years) at any dose level. In the teenage group (12 to under 18 years), 2 out of 4 participants receiving the 250 mg/m² dose were reported to have had dose-limiting toxicities; no figure was reported for the 300 mg/m² group in that age bracket. For the secondary outcomes, the reported data shows that liver-related abnormalities (hepatic injury) were recorded in a small number of participants across several groups. Changes in heart electrical activity (a measurement called QTc interval prolongation) were reported in a small number of participants, particularly in the teenage dose groups. No abnormal calcium levels meeting the severity threshold were reported in any group. For the measure looking at how leukaemia responded to treatment (such as remission or disease progression), the reported values were all zero across the groups included, meaning no responses of any category were recorded in the data submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02105116 · results posted 26 July 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 6 participants who had a form of blood cancer and were being assessed for a two-stage treatment approach. The plan was for participants to first receive standard chemotherapy to achieve a complete remission (meaning no detectable cancer), and then, if that was achieved, go on to receive an experimental treatment called donor lymphocyte infusion (DLI) — a procedure where immune cells from a donor are given to the patient. The trial was measuring things like side effects from the experimental therapy, how many participants responded to it, how long remissions lasted, and survival without disease progression. The reported data shows that none of the 6 participants were able to move on to the experimental treatment phase. This was because none of them achieved a complete remission after the initial standard chemotherapy, which was the required step before the experimental therapy could be given. As a result, no participant actually received the donor lymphocyte infusion. The reported data also notes that one participant died during the standard chemotherapy phase, before becoming eligible for the experimental treatment. Because no participants reached the experimental treatment stage, no outcome numbers were recorded for any of the primary or secondary measures — the data was simply not available to report. Because none of the participants received the experimental therapy, the trial was unable to produce results about how that treatment performed. The reported data shows only that the standard chemotherapy step proved to be a significant barrier for this particular group of 6 people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00987480 · results posted 10 July 2018

    According to the results reported on ClinicalTrials.gov, 45 people took part in this trial, and all 45 completed the study. Every participant received a chemotherapy-based treatment followed by a stem cell transplant using what are called "CD34+ selected" donor cells — a way of preparing donated stem cells before they are given to the recipient. The trial was measuring several things: whether participants' bone marrow successfully started producing white blood cells again after the transplant (called neutrophil engraftment), whether any participants died early as a result of the transplant procedure, and whether participants developed a condition called graft-versus-host disease (GvHD) — where donated cells can react against the recipient's body, either in the short term (acute) or longer term (chronic). The reported data shows that, out of 45 participants, 44 were recorded as having successful neutrophil engraftment (bone marrow recovering and producing white blood cells), while 1 participant's result was reported separately — though the data does not fully clarify the outcome for that individual. The reported data shows that zero participants experienced early transplant-related death. For the short-term (acute) form of GvHD, the reported figure was 6.7% of participants. For the longer-term (chronic) form of GvHD, the data reports 3 participants in one category and 42 in another, though the specific breakdown of those categories was not clearly labelled in the submitted data. The reported data shows that, looking out to three years after transplant, 80% of participants were recorded as still alive (overall survival), and 77.8% were recorded as alive and free from relapse or graft failure (disease-free survival). These figures represent what was observed in this specific group of 45 participants over that time period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00422591 · results posted 12 June 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 175 people, all of whom received a combination of two chemotherapy medicines called idarubicin and cytarabine. Of those 175 participants, 169 completed the study and 6 did not. The trial was measuring how many people achieved what is called a "complete response" — meaning their bone marrow and blood counts returned to normal levels — as well as how long people went without a setback (event-free survival) and how long people lived overall (overall survival). The reported data shows that, out of all participants, 98 achieved a complete response. The remaining figures reported alongside this were 4, 9, 7, and 51 participants, though the data as submitted does not clearly label what each of these specific numbers refers to, so it would not be accurate to describe them further. For the two time-based measures, the reported data shows a median event-free survival — that is, the midpoint time before a setback such as no response, relapse, or death — of 4.7 months. The reported median overall survival, meaning the midpoint time from the start of treatment until death, was 11.3 months. These figures are median estimates, meaning half of participants in the study reached that point sooner and half took longer. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01894477 · results posted 21 May 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT01894477) involved 102 people in total — 35 in Arm A, who received a combination of treosulfan and fludarabine phosphate, and 67 in Arm B, who received the same two medicines plus total body irradiation (a form of radiation treatment). The trial was looking at how participants responded to these conditioning regimens before a stem cell transplant, with the main goal being to track how many people did not experience their disease coming back or getting worse within the first six months. The reported data shows that, out of the 35 people in Arm A, 20 did not have their disease progress within six months. In Arm B, 48 out of 67 participants did not experience progression within that same period. For one of the secondary measures — the number of participants who developed a condition called acute graft-versus-host disease (a reaction where transplanted cells attack the recipient's body) — the reported data shows 29 out of 35 participants in Arm A and 50 out of 67 in Arm B experienced this. Several other secondary outcomes that were listed — including rates of chronic graft-versus-host disease, relapse or progression over the longer term, deaths not related to the disease returning, and overall survival — had no data reported on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01569295 · results posted 27 February 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 416 people with a blood cancer (207 in one group and 209 in another). Participants were randomly assigned to receive either idelalisib plus two chemotherapy medicines (bendamustine and rituximab), or a placebo (a dummy treatment) plus those same two chemotherapy medicines. The trial's main focus was on how long people went without their disease getting worse — a measure called "progression-free survival." Several secondary measures were also tracked, including how many people's cancer responded to treatment, how much their lymph nodes shrank, how long people lived overall, and how many achieved a complete response (meaning no detectable signs of disease). The reported data shows that, for the main measure of progression-free survival, the idelalisib group went a median (middle value) of 21.8 months before their disease progressed or they passed away, compared with 11.1 months in the placebo group. For the secondary measures, the overall response rate (the percentage of people whose cancer shrank or disappeared for at least 12 weeks) was reported as 70.0% in the idelalisib group versus 45.5% in the placebo group. The lymph node shrinkage rate was reported as 96.9% versus 60.9%. The complete response rate (no detectable signs of disease) was 4.3% versus 0.5%. For overall survival, the reported median was 56.2 months in the idelalisib group compared with 42.6 months in the placebo group. It is worth noting that zero participants in either group were recorded as having "completed" the study in the formal sense, with the data indicating most participants moved into or dropped out during a long-term follow-up phase. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01980888 · results posted 11 October 2017

    According to the results reported on ClinicalTrials.gov, this trial (NCT01980888) enrolled 311 people with a type of blood cancer called chronic lymphocytic leukaemia (CLL). Participants were randomly split into two groups: 157 people received idelalisib combined with two chemotherapy medicines (bendamustine and rituximab), and 154 people received a placebo (a dummy pill) combined with the same two chemotherapy medicines. The main thing the trial set out to measure was "progression-free survival" — that is, how long participants went without their disease getting worse or dying. It also aimed to measure a number of other things, including how many people's cancer responded to treatment, how long people lived overall, and whether traces of cancer became undetectable in the bone marrow. The reported data shows that the numbers for the primary outcome — progression-free survival — were listed as "NA" (not available) for both groups. For all of the secondary outcomes, including overall response rate, complete response rate, overall survival, and others, no numerical results were submitted to ClinicalTrials.gov either. The reported data also shows that very few participants were recorded as completing the study: 13 in the idelalisib group and 21 in the placebo group, with the large majority in both groups not completing the trial. Because the key outcome data was not reported on ClinicalTrials.gov, it is not possible to describe what the trial found about how the two groups compared. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02013167 · results posted 9 August 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 405 people with a type of blood cancer (acute lymphoblastic leukaemia that had returned or was not responding to treatment). Participants were randomly assigned to one of two groups: 134 people were assigned to standard chemotherapy and 271 to a medicine called blinatumomab. The trial's main goal was to measure how long participants lived overall, and secondary goals included looking at how many people's cancer went into remission (where signs of disease dropped to very low or undetectable levels) and how long that remission lasted. The reported data shows that, on average, participants in the standard chemotherapy group lived for 4.0 months from the time they joined the trial, compared to 7.7 months in the blinatumomab group. For remission rates measured within 12 weeks of starting treatment, the reported data shows that approximately 15.7% of the chemotherapy group achieved a full remission (complete blood count recovery), compared to 33.6% in the blinatumomab group. When a broader definition of remission was used — including those with partial or incomplete blood count recovery — 24.6% of the chemotherapy group and 43.9% of the blinatumomab group met that threshold. At the six-month mark, 12.5% of the chemotherapy group and 30.7% of the blinatumomab group were reported to be alive and free from a relapse event. Among those who did achieve full remission, the reported duration of that remission was 7.8 months for chemotherapy and 8.3 months for blinatumomab; when the broader remission category was used, the reported durations were 4.6 months and 7.3 months respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00839982 · results posted 11 July 2017

    According to the results reported on ClinicalTrials.gov, a total of 35 people took part in this trial, divided into four groups that each received a different dose of an oral chemotherapy medicine called clofarabine. The groups had 4, 26, 2, and 3 participants respectively, and all 35 people completed the study. The trial was primarily looking at two things: how many participants experienced serious side effects at each dose level (called "dose-limiting toxicities" — meaning harmful reactions severe enough to set a ceiling on how much of the medicine could be given), and what the highest dose was that still kept those reactions to an acceptable number. It also looked at how participants' disease responded to treatment, and how long participants lived without their disease returning. The reported data shows that no participants in the lowest dose group experienced a dose-limiting toxicity, while 4 out of 26 in the second group, 2 out of 2 in the third group, and 2 out of 3 in the fourth group did. Based on these numbers, the trial identified 20 mg per day (taken for 5 days) — which corresponds to Dose Level 2 — as the maximum tolerated dose. For treatment response in Dose Level 2 (the largest group of 26 people), the reported data shows 10 participants had no signs of leukaemia with full blood count recovery, 1 had no signs of leukaemia but without full blood count recovery, and 15 did not respond. Across all groups combined, the reported median time without the disease returning was 7.4 months, and the reported median overall survival (how long participants lived from the start of the trial) was 6.8 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00607997 · results posted 28 June 2017

    According to the results reported on ClinicalTrials.gov, this trial looked at a drug called vosaroxin given to adults aged 60 and over who had been newly diagnosed with a type of blood cancer called acute myeloid leukaemia (AML) and had not yet received treatment. A total of 113 people took part across four different dosing schedules — varying when and how much of the drug was given. The trial's main goal was to measure how many participants reached a state called "remission," meaning their blood and bone marrow counts returned to near-normal levels after treatment. The reported data shows that, looking at all 113 participants together, about 31.9% reached remission (combining two types of remission the trial tracked). Across the individual schedules, the remission rates ranged from about 25% to 41.4%. For how long participants remained free of leukaemia after remission (called leukaemia-free survival), the reported figures ranged from around 4.9 to 10.9 months depending on the schedule, with an overall figure of about 6.1 months. The reported data also shows that overall survival — how long participants lived from the start of the trial — ranged from about 5.6 to 8.6 months across the schedules, with an overall figure of about 7.0 months. Regarding deaths during the study, the reported data shows 12 deaths were recorded in an early time period and 35 across the full study period combined, though the way this data was reported makes a precise breakdown across groups difficult to describe simply. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01609023 · results posted 14 June 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 67 participants, all of whom received the medicine rituximab. The trial was measuring how participants responded to the treatment over time, including whether their disease got worse, whether it appeared to shrink or disappear, and what unwanted medical events occurred. Of the 67 people who started, 34 completed the trial and 33 did not complete it. The reported data shows that the primary thing being tracked was the occurrence of adverse events — that is, any unwanted medical occurrence during the study. According to the results, 89.6% of participants experienced at least one such event. For the secondary measures, the data shows that across different time points in the study, the percentage of participants whose disease was recorded as getting worse ranged from approximately 5.8% to 17.5%. The percentage of participants recorded as having an "objective response" — meaning their disease either disappeared completely or shrank considerably — ranged from around 58.5% to 84% depending on the time point measured. Complete disappearance of measurable disease was recorded in roughly 37.5% to 44.1% of participants at various time points, while a meaningful shrinkage (but not complete disappearance) was recorded in roughly 22.5% to 42% of participants. The reported data shows that the figure for progression-free survival — the length of time before disease worsened or death occurred — was not reported as a usable number in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00782067 · results posted 6 June 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 116 people who all received the drug midostaurin (also called PKC412). The trial was studying people with certain rare blood and immune conditions involving abnormal mast cells (a type of white blood cell). The main thing the trial was measuring was whether participants showed a meaningful improvement in specific serious disease-related symptoms, called "C-Findings" — these are symptoms directly linked to the mast cell disease. Of the 116 who started, 89 were included in the main group used to assess this response, and the reported data shows that none of the 116 participants were recorded as having "completed" the trial. The reported data shows that, among the 89 participants in the primary analysis group, 59.6% were classified as responders — meaning they showed either a major or partial improvement in their disease-related symptoms as judged by an independent review committee. For those who did respond, the reported median time until a response was first recorded was 0.3 months (roughly one to two weeks). The median duration of that response — how long it lasted before the disease progressed again — was reported as 31.4 months. The median time before the disease progressed or death occurred (for any reason) was reported as 17.0 months. Two figures were reported for overall survival (time from treatment start to death from any cause): 26.8 months and 28.7 months, though the data does not explain why two figures were given. Regarding side effects, the reported data shows that 100% of participants experienced at least one adverse event (an unwanted medical event during the trial), 75.9% experienced a serious adverse event, and 21.6% experienced a death during the study period — though the data does not specify the causes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02044822 · results posted 11 May 2017

    According to the results reported on ClinicalTrials.gov, this trial (NCT02044822) enrolled 102 people who received a combination of two medicines — idelalisib and rituximab — as treatment for their condition. The trial was designed to measure how many participants responded to the treatment (meaning their disease showed signs of shrinking or improving), how long any response lasted, and how long participants lived without their disease getting worse. By the time the trial ended, 9 participants had completed the study, while 93 did not complete it. The reported data shows that, unfortunately, no numerical results were submitted to ClinicalTrials.gov for any of the outcome measures in this trial. This includes the primary measure — the proportion of participants whose disease responded to treatment — as well as all six secondary measures, which looked at things like how long responses lasted, how many people achieved a full response, how long it took for the disease to progress, and how long participants survived overall. Because these figures were not reported in the structured results data, it is not possible to describe what the numbers showed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00906945 · results posted 4 April 2017

    According to the results reported on ClinicalTrials.gov, a total of 39 people took part in this trial across six groups. The trial was testing a combination of three treatments — plerixafor, G-CSF, and a chemotherapy regimen called MEC — in people with a type of blood cancer. The first part of the trial (Phase I) aimed to find the highest dose of plerixafor that could be given alongside the other treatments without causing too many serious side effects. The second part (Phase II) then looked at how many participants achieved a specific type of remission — meaning very few cancer cells were detectable in the bone marrow and blood counts had recovered to certain levels. The reported data shows that in Phase I, the highest dose level identified was 750 micrograms per kilogram per day. In Phase II, which included 16 participants at that dose level (14 of whom completed the study), 30% of participants were reported to have achieved a complete remission or a complete remission with incomplete blood count recovery. Regarding blood count recovery times, the reported data shows it took an average of 38 days for white blood cells (neutrophils) to reach a lower recovery threshold, 40 days to reach a higher recovery threshold, and 32 days for platelets to recover to the measured level. For side effects, the data reported counts of adverse events by severity grade, with 9 events recorded at Grade 3 severity in one category and 20 Grade 3 events in another; Grade 4 and Grade 5 events were reported as zero in the categories listed. Note that the adverse event data as submitted was not fully labelled by event type, so a complete breakdown cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01659021 · results posted 31 March 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 261 people with chronic lymphocytic leukaemia (CLL), who were randomly assigned to one of two groups: 174 people received a combination of two medicines — idelalisib and ofatumumab — and 87 people received ofatumumab on its own. The trial was primarily measuring **progression-free survival**, which is the length of time participants went without their disease getting worse or dying. A number of secondary measures were also tracked, including how many people's cancer responded to treatment, how long people survived overall, and how lymph nodes (glands) responded. The reported data shows that, on average, participants in the combination group went 16.6 months before their disease progressed or they died, compared with 8.0 months in the ofatumumab-alone group. For overall survival (time from the start of the trial until death from any cause), the combination group averaged 45.2 months and the ofatumumab-alone group averaged 39 months. When looking at tumour response — meaning whether the cancer showed signs of shrinking — 75.3% of people in the combination group had a measurable response, compared with 17.2% in the ofatumumab-alone group. Lymph node shrinkage of 50% or more was recorded in 92.7% of the combination group versus 4.9% of the ofatumumab-alone group. A complete response (where all signs of disease disappeared) was rare, recorded in just 1.1% of the combination group and 0% of the ofatumumab-alone group. For a specific subgroup of participants who had a particular genetic change (chromosome 17p deletion and/or TP53 mutation), the reported progression-free survival figures were 16.2 months for the combination group and 5.8 months for the ofatumumab-alone group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02099266 · results posted 17 March 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 15 people who received hyperbaric oxygen (HBO) treatment — a therapy where a person breathes pure oxygen inside a pressurised chamber — alongside umbilical cord blood stem cell transplantation. All 15 participants completed the study. The trial was primarily looking at whether HBO treatment caused any serious harmful reactions (called "treatment-limiting toxicities") within 24 hours of each session, such as a collapsed lung, death, or severe side effects judged by the treating doctor to be related to HBO therapy. The reported data shows that, for the primary outcome, measurements of 15, 12, 12, and 13 participants were recorded across the four reported data points — though the trial record does not provide enough detail to explain exactly what each of these figures individually represents, so a full breakdown cannot be given here. For the secondary outcomes, participants were split into two groups based on their transplant preparation approach. The reported data shows that those in the "reduced-intensity conditioning" group took a median (middle value) of 7 days to reach neutrophil recovery (a measure of white blood cell count returning to a certain level), while those in the "myeloablative conditioning" group — a more intensive preparation — took a median of 24.5 days. Additionally, the reported data shows that 7 out of 7 participants in the reduced-intensity conditioning group achieved complete engraftment, meaning their bone marrow showed more than 90% donor cells at the assessment point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00528398 · results posted 6 February 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 111 participants, all of whom received a combination of two chemotherapy medicines — idarubicin and cytarabine — as treatment for leukaemia. All 111 participants were recorded as having completed the study. The trial was primarily measuring how many participants achieved what is called "complete remission" — meaning their blood counts returned to near-normal levels, no leukaemia blast cells (abnormal cancer cells) were detectable in the blood, and the bone marrow showed healthy cell development with less than 5% blast cells remaining. The reported data shows that, of the 111 participants, 77 achieved complete remission, 32 did not achieve this result, and 2 participants had an outcome that was not clearly categorised in the data as provided. For the secondary outcome, a bone marrow test was carried out seven days after the start of chemotherapy to check for the presence or absence of leukaemia cells. The reported data shows that 17 participants had a bone marrow result described as "positive" (leukaemia cells still detected), 90 had a "negative" result (leukaemia cells not detected), and 4 participants had a result that was not clearly categorised. It is worth noting that the structure of the data as submitted makes it difficult to be fully certain how all subgroups map to each category, and some detail may not have been reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01202877 · results posted 7 November 2016

    According to the results reported on ClinicalTrials.gov, this trial looked at a combination of two medicines — 5-azacytidine and PKC412 (midostaurin) — in people with certain blood cancers (myelodysplastic syndrome and acute myeloid leukaemia). The trial ran in two stages: a smaller Phase I stage to test two different doses of PKC412 (25 mg and 50 mg), and a larger Phase II stage. In total, 54 people started the trial — 6 in the 25 mg group, 8 in the 50 mg group, and 40 in the Phase II group. Most participants finished the study, with 47 out of 54 completing it. The reported data shows that the trial measured how well participants' disease responded to the treatment combination. Responses were placed into categories: complete remission (CR, meaning very low levels of abnormal cells with blood counts recovered), complete remission with incomplete blood count recovery (CRi), a state where abnormal cells were very low but blood counts weren't fully specified (MLFS), and partial remission (PR, meaning a significant but incomplete reduction in abnormal cells). According to the results reported on ClinicalTrials.gov, in the Phase II group of 40 people, 1 participant achieved a CR, 4 achieved a CRi, 6 achieved MLFS, and 1 achieved a PR. In the smaller Phase I groups, the reported numbers were very low — 1 CRi each in the 25 mg and 50 mg groups, and no other response categories recorded in those groups. The reported data also shows that when looking at "overall response" within 6 months — counting anyone who had any of the above response types — 1 person responded in the 25 mg group, 1 in the 50 mg group, and 12 out of 40 in the Phase II group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00880269 · results posted 9 September 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 59 people in total — 32 in a group called Stratum A and 27 in Stratum B. The trial was studying a treatment for a type of blood cancer called AML (acute myeloid leukaemia). The main thing being measured was how many participants achieved a "complete remission" — meaning their cancer showed no sign of disease in tests, either fully (CR) or almost fully, with some blood count still recovering (CRi). The trial used a two-stage design, where results from the first stage would decide whether to keep enrolling more participants. The reported data shows that in Stratum A, about 3.1% of participants achieved a complete remission of any kind — which worked out to just 1 person out of 32. In Stratum B, about 7.4% achieved any complete remission — which was 2 people out of 27. The trial's plan required at least 4 participants in each group to reach complete remission before moving to the second stage of enrolment. Because neither group reached that threshold, the trial did not proceed to its second stage. The reported data also shows that in both groups, roughly 40–41% of participants had stable disease, and around 52–56% had their disease get worse or did not respond. Notably, all participants across both groups are recorded as having discontinued treatment, and none are recorded as having "completed" the trial in the usual sense. For the secondary outcomes — which included things like partial response, time to remission, duration of remission, survival without a disease event, and overall survival — no numerical data was reported on ClinicalTrials.gov, so those figures are not available to describe here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00760877 · results posted 16 August 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 207 people — 104 in the nilotinib group and 103 in the imatinib group — all of whom had a type of blood cancer called chronic myelogenous leukaemia (CML). The trial was measuring how many participants reached a specific level of disease response called "complete molecular response" (CMR), which means the particular abnormal gene linked to CML (called BCR-ABL) became undetectable in blood tests. Forty-six participants in the imatinib group later crossed over to receive nilotinib during the study. The reported data shows that in the first 12 months, 13 out of 104 participants in the nilotinib group and 6 out of 103 in the imatinib group reached confirmed CMR. Over longer timeframes, the reported data shows that by 24 months, 24 nilotinib participants and 11 imatinib participants had reached confirmed CMR; by 36 months, those numbers were 29 and 21 respectively; and by 48 months, 32 and 21 respectively. Of the 46 imatinib participants who crossed over to nilotinib, the reported data shows that 3 reached CMR at one point, 6 at another, and 9 at a third — though the specific timepoints for these crossover figures were not clearly detailed in the submitted data. For three other outcomes that were tracked — progression-free survival, event-free survival, and overall survival (all measured in months) — the reported data shows that no numerical values were submitted to ClinicalTrials.gov, so those figures are not available to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00492401 · results posted 27 June 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 55 people, all of whom received a drug called decitabine. All 55 participants completed the study. The trial was looking at how many people achieved what is known as "complete remission" — meaning their blood cancer showed no detectable signs in bone marrow tests and their blood counts recovered to acceptable levels. The trial also aimed to measure certain biological markers in participants' blood and bone marrow, including DNA methylation (chemical tags on DNA that affect how genes work), specific proteins involved in those chemical processes, and levels of a type of haemoglobin called HbF. The reported data shows that out of 55 participants, 25 met the criteria for complete remission. This figure combined two categories: those whose blood counts fully recovered alongside clear bone marrow results, and those whose bone marrow results were clear but whose blood counts had not fully returned to normal. For one of the secondary biological measures — levels of a protein called DNMT, which is involved in controlling gene activity — the reported data shows some numerical differences between participants who responded to treatment and those who did not, though the figures reported are highly technical values (delta delta CT values, a laboratory measurement unit). The remaining secondary measures, including DNA methylation, HbF levels, and general gene expression, had no numerical results reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01300247 · results posted 24 June 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 41 people with chronic lymphocytic leukaemia (a type of blood cancer). Participants were split into two groups: 21 people received obinutuzumab combined with fludarabine and cyclophosphamide, and 20 people received obinutuzumab combined with bendamustine (these are all names of cancer medicines). The trial was primarily measuring whether participants' immune systems developed antibodies against obinutuzumab itself — a reaction sometimes called a "human anti-human antibody" (HAHA) response, which can affect how the body responds to a treatment. The trial also set out to measure how the drug moved through the body over time, including how it was absorbed, how concentrated it became in the blood, and how quickly it was cleared. The reported data shows that, for the primary outcome, zero participants in either group developed these antibodies against obinutuzumab — that is, 0 out of 21 in the first group and 0 out of 20 in the second group. For all of the secondary outcomes — which looked at how the drug was absorbed and processed by the body (measures such as drug concentration over time, peak concentration, lowest concentration between doses, rate of clearance, and volume of distribution) — no numerical results were reported in the data submitted to ClinicalTrials.gov. It is worth noting that 17 of 21 participants completed the study in the first group, and 18 of 20 completed it in the second group; the reasons why the remaining participants did not complete the study were not included in the data provided here. The reported data shows only what was measured and the numbers submitted — it does not indicate anything about whether the treatments performed better or worse than alternatives. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01890746 · results posted 14 June 2016

    According to the results reported on ClinicalTrials.gov, this trial (NCT01890746) enrolled 74 people in the eltrombopag (a daily tablet) group and 74 people in the placebo (dummy pill) group — 148 participants in total. The trial was primarily measuring safety and tolerability, meaning it was looking at what kinds of unwanted medical events occurred, how the heart was functioning (specifically the percentage of blood pumped out with each heartbeat, called left ventricular ejection fraction or LVEF), and how blood and chemistry lab results changed over the course of the study. The reported data shows that, when it came to any unwanted medical event (called an adverse event), 72 out of 74 people in the eltrombopag group and 66 out of 74 in the placebo group experienced at least one. Serious adverse events — those involving hospitalisation, life-threatening situations, or similar — were reported in 24 people in the eltrombopag group and 14 in the placebo group. Regarding heart function, both groups showed a small decrease in their LVEF score from the start of the study to day 42; the eltrombopag group had an average decrease of around 2.5 percentage points at one measurement point and 4.1 at another, while the placebo group showed decreases of around 4.3 and 5.7 percentage points respectively. For liver-related abnormalities in blood enzyme levels, 2 people in the eltrombopag group and 6 in the placebo group were reported to have these. The reported data also shows various changes in blood and chemistry lab values across both groups, and heart rhythm (ECG) readings were noted as clinically significant in 2 people in the eltrombopag group and 1 in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01254188 · results posted 3 March 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 421 people, all of whom received a medicine called nilotinib. The trial was studying nilotinib as a treatment for a type of blood cancer called chronic myeloid leukaemia (CML). Of the 421 people who started, 328 completed the trial and 93 did not. The main thing the trial set out to measure was what proportion of participants reached a specific level of reduction in cancer-related markers in their blood — known as a "major molecular response" (MMR) — within 12 months. Several other things were also tracked, including how long it took to reach that response, how long the response lasted, and how many people were still alive over time. The reported data shows that 70.8% of participants reached the MMR target within 12 months. For the secondary measurements, the reported median time to first reaching MMR was 6 months (meaning half of those who reached it did so within 6 months). The data also reported on how many participants who achieved MMR appeared to maintain it over time, with figures ranging from 100% at the earliest time point down to approximately 85.2% at the latest time point measured. A separate measure looked at a bone marrow test result called "complete cytogenetic response" — where no abnormal chromosomes could be detected — and reported that 58.7% of participants reached this marker. Among those who did reach it, the reported figures suggested it was largely maintained over the following two years. Reported overall survival figures (the proportion of participants still alive) ranged from 99.8% at the earliest time point to 97.6% at the latest time point reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00002766 · results posted 22 February 2016

    According to the results reported on ClinicalTrials.gov, this trial (NCT00002766) involved two groups of participants being treated for leukaemia. One group, called "All-2", enrolled 81 people, and the other group, called "L-20", enrolled 89 people. The main thing the trial was measuring was whether participants achieved what researchers call a "complete remission" — meaning all detectable signs of leukaemia disappeared for at least four weeks, with blood cell counts returning to near-normal levels and very few abnormal cells remaining in the bone marrow. The reported data shows the following numbers of participants across several response categories for the All-2 group and the L-20 group respectively: 50 and 50 participants achieved complete remission; 14 and 11 had another category of response (the label for this specific category was not fully detailed in the submitted data); 5 and 14 fell into a further category; 8 and 10 in another; and 1 and 0 in the final category. Secondary outcome measure results were not reported in the data submitted to ClinicalTrials.gov, so those figures cannot be described here. It is worth noting that the reported numbers describe what was observed in this particular group of trial participants at that time, and do not on their own tell us whether one approach is better or worse than another. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01227577 · results posted 8 February 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 128 people, all of whom received a medicine called nilotinib. The trial was measuring how well participants with a type of blood cancer responded to this treatment, by looking at changes in specific genetic markers in their blood and bone marrow. By the end of the study, 93 participants had completed it, while 35 did not finish for various reasons. The reported data shows that the main thing being measured — called a "complete molecular response" (meaning the cancer-related gene signal in the blood dropped to a very low, hard-to-detect level, confirmed by two separate tests three months apart) — was recorded in 34 out of 128 participants. For two other measures of response that looked at bone marrow and blood markers (called complete cytogenetic response and major molecular response, which represent different levels of reduction in cancer-related signals), the reported data shows 93 participants and 94 participants respectively reached those markers. The time it took participants to first reach these two markers was reported as approximately 5.5 months and 5.7 months on average. One participant was reported to have had their disease progress to a more advanced stage during the study. Some duration and time figures for certain measures were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00648037 · results posted 1 February 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 26 people who were undergoing a type of stem cell transplant (specifically, a T-cell depleted transplant from an unrelated or partially mismatched donor). The trial was investigating the use of a medicine called rituximab given as a preventive measure around the time of transplant. The main thing the trial was measuring was safety — specifically, whether giving rituximab in this way raised the risk of certain serious complications, including transplant failure, severe graft-versus-host disease (where donor cells attack the recipient's body), death related to treatment, serious infection, or a condition called EBV-LPD (a rare complication involving abnormal cell growth triggered by a common virus). The reported data shows that of the 26 people who started the trial, 10 were recorded as having completed it, while 16 did not complete it (the reasons for non-completion were not detailed in the submitted data). For the primary outcome measuring safety, the reported data shows that 23 participants were counted in the safety assessment. No further breakdown of individual safety events or rates was provided in the submitted results data, so more detailed figures for specific complications were not reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00014495 · results posted 22 January 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 32 people in total across four groups. Each group received a different dose of a radioactive antibody treatment called bismuth-labelled HuM195 (also known as bismuth Bi 213 monoclonal antibody M195), given alongside a chemotherapy drug called cytarabine. The trial was testing this combination in people with advanced blood cancers affecting the myeloid cells (a type of blood cell). The main goal was to find the highest dose of the radioactive antibody that could be given without causing unacceptable side effects — this is called the "maximum tolerated dose." Three people were in the lowest dose group, three in the next, 20 in the third, and six in the highest dose group. Most participants completed the study, with two not completing it (one each from the two higher dose groups). The reported data shows that the maximum tolerated dose of the radioactive antibody was identified as 1 mCi/kg (milliCuries per kilogram of body weight — a unit used to measure radioactive doses). This was the dose level that had the largest group of 20 participants enrolled, which is consistent with how these types of dose-finding trials typically focus enrolment around the key dose level. No other outcome measures beyond this primary finding were included in the submitted results data. The reported data does not include any additional figures for response rates or other measures, so those results were not reported in this submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01724177 · results posted 5 January 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 26 participants, all of whom received the drug lenalidomide. The trial was studying its use in people with a type of blood cancer (specifically a form of lymphoma), and none of the 26 participants were recorded as having completed the study — all 26 exited before the scheduled end point, though the data does not detail the reasons for each individual. The main thing the trial set out to measure was the proportion of participants whose disease showed a meaningful reduction — defined as a complete disappearance of detectable disease, a near-complete disappearance, or at least a 50% shrinkage in measurable tumour areas. The reported data shows that, according to the trial's independent review committee, approximately 42.3% of participants (roughly 11 out of 26) met the criteria for one of those response categories. For the secondary measurements, the reported data shows that the estimated time participants went without their disease getting worse (called progression-free survival) was around 16.3 weeks, and the estimated time from starting treatment until the disease began progressing was also reported as 16.3 weeks. Among those who did show a response, the estimated length of time that response lasted was reported as approximately 24.1 weeks. The time from first dose to first recorded response was reported as around 8.1 weeks. Regarding side effects, the reported data shows that all 26 participants experienced at least one treatment-emergent adverse event (an unwanted health event that occurred during or shortly after treatment), with 25 experiencing what were graded as severe or worse events, and 17 experiencing what were classified as serious adverse events. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01292603 · results posted 15 December 2015

    According to the results reported on ClinicalTrials.gov, this trial involved two parts and studied a medicine called rituximab, which was being looked at in two different forms: the standard drip (intravenous, or "IV") and a newer under-the-skin injection (subcutaneous, or "SC"). In Part 1, a total of 64 participants were enrolled across three SC dose groups (1400 mg, 1600 mg, and 1870 mg) plus a small group of 8 who did not receive an SC dose, with the goal of finding which SC dose produced blood levels of the medicine that were at least as high as the IV version. In Part 2, 88 participants received the IV form and 88 received the SC form, to confirm those findings in a larger group. The reported data shows that in Part 1, the 1600 mg SC dose was selected as the dose whose blood levels were considered non-inferior (meaning not meaningfully lower) to the IV dose. In Part 2, at the key measurement point (Cycle 5), the reported minimum blood concentration — the lowest level of the medicine in the blood just before the next dose — was 61.50 micrograms per millilitre (µg/mL) for the IV group and 97.53 µg/mL for the SC group. For additional measurements taken at Cycle 6, the reported total drug exposure over time was 3,630 µg·day/mL (IV) versus 4,089 µg·day/mL (SC); the reported peak blood concentration was 280 µg/mL (IV) versus 202 µg/mL (SC); the time to reach that peak was approximately 0.22 days (IV) versus 3.14 days (SC); and the time for blood levels to fall by half was approximately 30 days in both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00145626 · results posted 14 December 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 19 infants and young children with high-risk blood cancers. They all received a stem cell transplant from a family member whose tissue type was not a perfect match (known as a "haploidentical" donor). The transplant preparation did not include full-body radiation, and the donated stem cells were specially processed to remove certain immune cells before being given to the child. A follow-up infusion of a different type of immune cell (called NK cells) was also given. Of the 19 who started the trial, 14 completed it and 5 did not. The reported data shows that the estimated one-year survival rate — that is, the proportion of participants still alive one year after the transplant, calculated using a standard statistical method — was 50%. Regarding complications tracked in the trial: 3 participants died from causes related to the transplant procedure itself (rather than from their original illness returning); approximately 29% of participants experienced engraftment failure, meaning the donated cells did not take hold in the body as expected; and no participants died from a serious immune reaction called acute graft-versus-host disease (where donated immune cells attack the recipient's body) in the first 100 days. The reported data also shows that 1 participant developed a limited form of chronic graft-versus-host disease, while 13 participants did not develop any chronic form of this condition. A planned analysis to look at factors influencing one-year survival was not carried out, as the trial's small size meant the results would not have been meaningful. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00565058 · results posted 27 July 2015

    According to the results reported on ClinicalTrials.gov, this trial looked at a combination treatment — a drug called GTI-2040 given together with high-dose chemotherapy (cytarabine) — in people with a type of blood cancer called acute myeloid leukaemia (AML) that had either come back or not responded to earlier treatment. The trial was run in two stages: a smaller pilot phase and a larger Phase II phase. In total, 25 people took part — 10 in the pilot group and 15 in the Phase II group. Nine of the 10 pilot participants completed the study, while all 15 in the Phase II group completed it. The main thing the trial was measuring was the "overall response rate" — specifically, how many participants achieved a complete remission (meaning no detectable signs of leukaemia) or a near-complete remission (where the leukaemia appeared to clear but blood counts had not fully recovered). The reported data shows that 3 out of 10 people in the pilot group and 4 out of 15 people in the Phase II group met this response definition. The trial also recorded any unwanted or unexpected health events (called adverse events) that occurred during the study. The reported data shows that all 10 participants in the pilot group and all 15 in the Phase II group experienced at least one such event. More specific breakdowns of those events were partially reported in the data, but the full detail of the categories and their meanings was not provided in a way that can be fully described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01795716 · results posted 19 May 2015

    According to the results reported on ClinicalTrials.gov, this trial involved 21 people in total. It was a crossover study, meaning each participant took both medicines — one called Mesylate Imatinib Capsule and the other called Glivec (the brand-name version of imatinib) — with a 10-day "washout" break in between to clear the first medicine from their bodies before starting the second. The main thing the trial was measuring was how much of each medicine entered the bloodstream over time, using a measure called "area under the curve" (AUC) — essentially a way of capturing the total exposure to the medicine across a set period after taking a dose. The reported data shows that the AUC figure for the Mesylate Imatinib Capsule group was 37,256 micrograms per hour per millilitre (a unit measuring drug concentration over time in the blood). For Glivec, the reported AUC figure was 37,206 micrograms per hour per millilitre. These two numbers, as reported, were very close to each other. No secondary outcome measure data was included in the structured results provided. All 21 participants completed every stage of the trial, with no dropouts recorded at any phase. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01039376 · results posted 21 April 2015

    According to the results reported on ClinicalTrials.gov, this trial (NCT01039376) enrolled 240 people in the ofatumumab group and 240 people in an observation-only group — 480 participants in total. All participants had a type of blood cancer called chronic lymphocytic leukaemia (CLL). The trial was primarily measuring "progression-free survival" — that is, how long participants went before their disease got worse or they died. This was assessed in two ways: by the treating doctors and by an independent review panel. The reported data shows that, for progression-free survival as measured by the treating doctors, the ofatumumab group had a median (middle value) of about 34 months before disease worsening or death, compared with about 17 months in the observation group. The independent review panel's assessment gave similar figures — approximately 34 months for ofatumumab and about 15 months for observation. For overall survival (time from the start of the trial until death), the reported data shows a median of approximately 74 months for the observation group; the equivalent figure for the ofatumumab group was not reported in the data. The reported data also shows that 16 participants in the ofatumumab group and 8 in the observation group moved from a partial response to a complete response. The median time until participants needed their next cancer treatment was reported as approximately 36 months in the ofatumumab group and approximately 28 months in the observation group. The progression-free survival figures after the next round of treatment were not reported in the data for either group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00656617 · results posted 9 March 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 106 participants, all of whom received a combination of three medicines: idarubicin, ara-C (also known as cytarabine), and vorinostat. The trial was measuring how many participants were free from their disease getting worse over a seven-month period, as well as tracking how participants' disease responded to the treatment. Of the 106 who started, 99 were recorded as having completed the study, and 7 did not complete it. The reported data shows that 65% of participants were free from disease progression at the seven-month mark — meaning their condition had not worsened and they had not died during that period. Regarding how individual participants' disease responded, the reported data shows that 67 participants achieved a complete response (meaning bone marrow and blood counts returned to near-normal levels), 11 achieved a complete response but without full platelet (a blood component involved in clotting) recovery, and 24 participants had progressive disease (meaning their condition worsened after an initial response). The reported data shows zero participants achieved a partial response and zero were recorded in that category. It is worth noting these response figures add up to more participants than completed the study, and no further explanation for this was provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01074047 · results posted 26 February 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 488 people in total — 241 assigned to receive azacitidine (AZA) and 247 assigned to receive conventional care regimens (CCR), which refers to standard treatment options already in use. The trial was measuring how long participants lived overall, as well as a number of other time-related outcomes such as how long they lived without their disease getting worse, and how many achieved a full or partial remission (a reduction in signs of disease). The reported data shows that, for the primary outcome — overall survival, meaning the time from joining the trial until death from any cause — the median (the midpoint figure, where half of participants lived longer and half lived shorter) was 10.4 months in the azacitidine group and 6.5 months in the conventional care group. For the one-year survival rate, the reported data shows that approximately 46.5% of the azacitidine group and 34.3% of the conventional care group were still alive at the one-year mark. For event-free survival (how long participants went without their disease progressing or other setbacks), the reported figures were 6.7 months for azacitidine and 4.8 months for conventional care. Regarding remission rates, 27.8% of the azacitidine group and 25.1% of the conventional care group were reported to have achieved a full or near-full remission. Among those who did achieve remission, the relapse-free survival (time before disease returned) was reported as 9.3 months for azacitidine and 10.5 months for conventional care, and the duration of that remission was reported as 10.4 months and 12.3 months respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00045305 · results posted 19 January 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 17 people in a single treatment group (Arm I). All 17 were eligible and received treatment, but only 3 completed the study, with 14 not completing it. The trial was measuring how well a treatment worked for a blood condition, looking at things like whether participants achieved a "complete response" (meaning their blood counts and bone marrow returned to near-normal levels), how long they survived, how quickly their blood cells recovered after treatment, and whether they developed a condition called graft versus host disease (where transplanted cells attack the recipient's body). The reported data shows that 35.3% of participants achieved a complete response — that is, roughly 6 out of the 17 people met the criteria for their blood and bone marrow returning to near-normal. Of those who reached a complete response, the reported data shows that 1 person later experienced disease progression (the condition returning or worsening). The reported median overall survival — meaning the point at which half the group had passed away — was 1.2 years. The proportion of participants who developed graft versus host disease was reported as approximately 0.41, meaning roughly 41 in every 100 participants, or about 7 of the 17 people in this group. The reported data shows that, on average, participants' neutrophils (a type of white blood cell important for fighting infection) recovered within 18 days of the cell infusion, and platelets (cells that help blood clot) also recovered within a reported median of 18 days. It is worth noting that with only 17 participants in a single group and no comparison group, the numbers here represent a small and limited dataset. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00114959 · results posted 15 January 2015

    According to the results reported on ClinicalTrials.gov, this trial looked at a combination of two medicines — homoharringtonine and imatinib mesylate — given to people with a type of blood cancer called chronic myeloid leukaemia (CML). The trial enrolled 15 participants in total. The study was measuring whether participants responded to the treatment (for example, whether their disease returned to a less severe stage or their blood counts improved), as well as tracking any unwanted health events that occurred during the trial. Of the 15 people who started, 7 completed the study and 8 did not complete it. The reported data shows that for the main outcome measures looking at whether participants achieved a meaningful response — either those in the more advanced phases of CML or those in the earlier chronic phase — no numerical results were submitted to ClinicalTrials.gov for these measures. Similarly, no numbers were reported for the secondary outcome, which looked at whether the Philadelphia chromosome (an abnormal chromosome linked to this type of leukaemia) was suppressed in those who responded. Because these figures were not provided in the submitted data, they cannot be described here. The reported data does include figures for unwanted health events. Out of the 15 participants, all 15 experienced at least one adverse event (an unwanted health occurrence). Twelve participants experienced what are classified as serious adverse events — meaning events such as hospitalisation, life-threatening situations, or other significant health concerns. Of those serious adverse events, 7 were considered by the investigators to be potentially related to the study medicines. Two participants stopped treatment because of an adverse event. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00369317 · results posted 13 January 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 205 children with Down syndrome (aged under 4 years) who had been diagnosed with leukaemia (a blood cancer). All participants received a combination chemotherapy treatment programme. The trial was primarily measuring how many participants were still alive and free from a return of their cancer after three years. Of the 205 who started, 185 completed the study, and 20 did not complete it for reasons not detailed in the reported data. The reported data shows that, at the three-year mark, 90.1% of participants were recorded as "event-free" — meaning they had not experienced a relapse or other major setback during that period. The overall survival figure at three years was reported as 92.7%. Regarding secondary measurements, the reported data shows that approximately 98.5% of participants achieved a remission (a reduction or disappearance of signs of cancer) after the initial phase of treatment. The data also shows that around 91.2% of participants experienced at least one serious side effect (graded 3 or 4 on a standard medical scale, meaning significant or severe) at some point during their treatment. In terms of the biology of the leukaemia, approximately 45.1% of participants whose cancer type was recorded had a specific subtype called megakaryoblastic leukaemia, and approximately 89.1% of those tested were found to carry a particular gene change known as a GATA1 mutation. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00313586 · results posted 25 November 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 197 people in total across four groups. Participants were divided based on whether their condition had been brought on by previous cancer treatment ("treatment-induced cohort") or not ("non-treatment-induced cohort"). Within each of those two cohorts, people were assigned to receive either azacitidine on its own (Arm A) or azacitidine combined with another medicine called entinostat (Arm B). The trial's main goal was to measure what proportion of participants had a clinical response — meaning their disease showed a complete, partial, or significant improvement according to standard medical criteria. The reported data shows the following response proportions for each group. In the non-treatment-induced cohort, 0.32 (roughly 32 in every 100 participants) in the azacitidine-only arm showed a clinical response, compared with 0.27 (about 27 in every 100) in the azacitidine-plus-entinostat arm. In the treatment-induced cohort, 0.46 (about 46 in every 100) in the azacitidine-only arm showed a clinical response, compared with 0.17 (about 17 in every 100) in the combination arm. No secondary outcome measure data was included in the submitted results. It is also worth noting that only a small number of participants — 5 in each of the two non-treatment-induced arms, and none in the treatment-induced arms — were recorded as having completed the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02053610 · results posted 10 October 2014

    According to the results reported on ClinicalTrials.gov, this trial (NCT02053610) enrolled 663 participants in total — 330 in the rituximab plus chlorambucil group (RClb) and 333 in the obinutuzumab plus chlorambucil group (GClb). The trial was measuring how long people went without their disease getting worse or coming back — known as "progression-free survival" — as well as how many participants showed a response to treatment at the end of the treatment period and at their best point overall. The reported data shows that, for the main outcome, the median time without disease progression or death was 15.7 months in the RClb group and 28.9 months in the GClb group, as assessed by the treating doctors. A "median" here means the midpoint — half of participants in each group reached that time point before experiencing a progression event, and half had not yet. The reported percentage of participants who experienced a progression, relapse, or death during the study was 88.5% in the RClb group and 73.3% in the GClb group. When a separate independent review committee assessed the same data, they reported median progression-free survival of 14.9 months (RClb) and 26.7 months (GClb), with 55.5% and 30.9% of participants respectively having experienced a progression event by that review. For the secondary outcome of best overall response — meaning the proportion of participants who showed at least a partial improvement in their disease at any point — the reported figures were 7.0% achieving a complete response in the RClb group compared with 23.7% in the GClb group, with overall response rates (combining all response categories) also reported across the two groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00578539 · results posted 8 September 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 24 participants, all of whom completed the study with no drop-outs. The trial involved people undergoing stem cell transplantation, and it was designed to look at how a specific type of immune cell — called T regulatory cells (a small group of cells that play a role in controlling the immune system) — behaved and recovered in the body over the first year after the transplant. The reported data shows that the main thing being measured was the median percentage (that is, the middle value across all participants) of T regulatory cells found in the blood at one year after the transplant. These cells were measured as a proportion of a broader group of immune cells called CD4+ cells. The reported median figure was 6.9%, meaning that at the one-year mark, these regulatory cells made up about 6.9 out of every 100 of the relevant immune cells measured. No secondary outcome measure data appears to have been reported in the submitted results. It is worth noting that this trial was measuring a biological marker — a number that describes what was happening in participants' immune systems — rather than directly measuring symptoms or quality of life. The reported data shows only what was observed and recorded; it does not on its own indicate whether any particular level is better or worse for patients. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01184898 · results posted 27 August 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 36 participants, all of whom completed the study. The trial was looking at a combination treatment called Sirolimus and MEC (a chemotherapy regimen) for people with high-risk acute myeloid leukaemia (AML), a type of blood cancer. The main thing researchers were trying to measure was whether a drug called sirolimus could block a specific biological pathway (called mTOR) inside cancer cells, and whether the degree of that blockage was linked to how patients responded to treatment. The reported data shows that, among patients who survived long enough to be assessed, those who responded to treatment showed a reported 69% change in leukaemic blasts (the abnormal cancer cells measured in the blood and bone marrow), while those who did not respond showed a reported change of minus 36%. For the secondary measures — which looked at how many participants reached certain response milestones — the reported data shows that 11 participants achieved a complete response (meaning blood counts and bone marrow returned to near-normal levels), 2 participants achieved a complete response except that their platelet counts had not fully recovered, and 3 participants achieved a partial response (meaning some improvement in the bone marrow but not a full recovery). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01292135 · results posted 24 July 2014

    According to the results reported on ClinicalTrials.gov, this trial looked at a drug called ibrutinib (also known by its study name PCI-32765) when combined with two different chemotherapy regimens — one called BR (bendamustine plus rituximab) and one called FCR (fludarabine, cyclophosphamide, and rituximab) — in people with a type of blood cancer called chronic lymphocytic leukaemia. A total of 33 people took part: 30 in the ibrutinib-plus-BR group and 3 in the ibrutinib-plus-FCR group. The main thing the trial was set up to measure was whether a specific type of prolonged blood-related side effect (called prolonged haematologic toxicity) occurred during the first treatment cycle. The reported data shows that, for the primary measure, 0% of participants in both groups experienced that specific prolonged blood-related side effect in the first cycle. For the secondary measures, the trial also tracked other side effects and how participants' disease responded to treatment. In the BR group, 53.3% of participants had side effects that required the ibrutinib dose to be delayed or stopped, compared with 33.3% in the FCR group. Serious side effects were reported in 20% of the BR group and 33.3% of the FCR group. Severe side effects (graded 3 or higher on a standard medical scale) were reported in 66.7% of the BR group and 0% of the FCR group, though the FCR group was very small (only 3 people). The reported data also shows that 93.3% of the BR group and 100% of the FCR group had some level of disease response to treatment. Additionally, among BR group participants who had low blood cell counts at the start of the trial, 76.2% showed a sustained improvement in those counts; this figure was not reported for the FCR group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00415857 · results posted 30 April 2014

    According to the results reported on ClinicalTrials.gov, this trial looked at a vaccine called PR1 in people with a type of blood cancer (leukaemia). Participants were split into two groups: one group received PR1 combined with a drug called imatinib (2 people), and the other received PR1 combined with both imatinib and interferon (3 people). In total, just 5 people took part in the trial, and all 5 completed it. The trial was measuring two things: whether the vaccine reduced the amount of leukaemia detectable in the blood (called a "molecular response"), and whether it triggered a reaction from the immune system (called an "immunologic response"). The reported data shows that in both groups, zero participants achieved a molecular response — meaning no one in either group showed the required reduction in leukaemia markers in their blood within the measurement period. The reported data also shows that zero participants in either group showed an immunologic response — meaning no measurable increase in the specific immune cells being tracked was detected after vaccination. These figures were reported as 0% for the molecular response outcome and 0 out of 5 participants for the immune response outcome. It is worth noting that with only 5 participants in total, this was a very small trial, and the reported results reflect that limited number. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00724009 · results posted 18 March 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 29 participants, all of whom received the drug clofarabine. All 29 participants completed the study. The trial was measuring whether clofarabine could reduce the amount of abnormal cells in the bone marrow — specifically, whether it could bring bone marrow activity (cellularity) below 20% and the proportion of abnormal "blast" cells below 10%. The study also tracked a number of unwanted physical reactions (called adverse events) affecting the kidneys, liver, heart, and skin. The reported data shows that 52% of participants (roughly 15 out of 29) achieved the target reduction in bone marrow cellularity and blast cells. For the tracked adverse events, the reported data shows the following numbers of participants experienced reactions in each area (the data appears to reflect two levels of severity, though the exact severity categories were not labelled in the submitted results): kidney-related reactions were reported in 9 and 1 participants; liver-related reactions involving a substance called total bilirubin were reported in 14 and 3 participants; liver-related reactions involving a liver enzyme called SGOT were reported in 14 and 9 participants; heart-related reactions were reported in 2 and 0 participants; and skin-related reactions were reported in 1 and 0 participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00920140 · results posted 28 February 2014

    According to the results reported on ClinicalTrials.gov, this trial tested a drug called GSK1120212 (also known as trametinib) in people with certain blood cancers — specifically acute myeloid leukaemia (AML), myelodysplastic syndrome (MDS), and chronic myelomonocytic leukaemia (CMML). The trial had two phases: a Phase 1 dose-finding stage where 14 participants received either a lower dose (5 people) or a 2 mg daily dose (9 people), and a Phase 2 stage where 83 participants were enrolled across three groups based on their cancer type and gene mutation status. None of the participants were recorded as having "completed" the trial in the formal sense, meaning all either stopped early or moved on from that phase. The trial's primary focus was on tracking and recording untoward medical events (called adverse events) and serious adverse events, as well as changes in blood test results, heart rate, blood pressure, and body temperature. The reported data shows that in the Phase 1 dose groups, 6 out of the 5 participants in the lower-dose group experienced at least one adverse event, and 91 out of the 9 participants in the 2 mg group also had at least one adverse event — noting these numbers appear to reflect events counted across the broader trial population labelled under those dose groups. Serious adverse events were reported for 2 participants in the lower-dose group and 64 in the 2 mg group. For blood test results, the reported data shows that some participants in the 2 mg group had worsening results reaching severe or life-threatening grades for certain measures, including 28 participants for one blood count measure and smaller numbers for liver-related and other chemistry markers. Changes in heart rate, blood pressure, and temperature were also recorded across both dose groups, with larger numbers of changes observed in the 2 mg group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00666588 · results posted 6 February 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 52 children and young people in total across four groups. Each group received the drug bortezomib — either at different doses or in combination with different levels of prior chemotherapy exposure — to treat a form of childhood leukaemia. The trial was measuring two main things: how many participants had a serious reaction to the dose (called a "dose-limiting toxicity"), and how many participants' leukaemia went into remission (disappeared or greatly reduced) after the first round of treatment. The reported data shows that, for dose-limiting toxicities, only 1 out of 52 participants experienced this type of serious reaction, and that was in the group receiving the lower dose (1.0 mg/m²) with high prior chemotherapy exposure. The other three groups each reported zero such reactions. For remission during the first course of treatment, the reported data shows 4 out of 18 participants responded in the low prior-chemotherapy group at the standard dose, 2 out of 6 in each of the two high prior-chemotherapy feasibility groups, and 9 out of 22 in the high prior-chemotherapy efficacy group at the standard dose. The reported data also includes measurements from several laboratory tests — including tests looking at cell signalling activity, protein levels inside cells, and the depletion of specific leukaemia-related cells — taken across the groups. The protein expression results were not reported in the data. For the remaining lab measures, numerical results were recorded across the groups, though no data was reported for one of the four groups in the proteasome inhibition test. These laboratory results were described as exploratory, meaning they were gathered to help understand what was happening in the body rather than to reach firm conclusions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00372619 · results posted 3 February 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 74 participants across seven groups. Participants had either acute lymphoblastic leukaemia (ALL) or acute myeloid leukaemia (AML) — two types of blood cancer — and were given the drug clofarabine at one of two dose levels (40 mg/m² or 52 mg/m²). The trial was designed in two stages: an initial stage to check whether the treatment approach was practical and manageable ("feasibility"), and a later stage to look at how many patients achieved remission ("efficacy"). The main thing being measured was whether patients reached complete remission — meaning their bone marrow returned to a near-normal state with no detectable leukaemia cells and with blood counts recovering to acceptable levels. The reported data shows that, looking at the primary outcome of remission, the numbers of participants who met the remission criteria in each group were as follows: 1 out of 8 in the lower-dose ALL feasibility group; 2 out of 2 in the lower-dose AML feasibility group; 0 out of 3 in the higher-dose ALL feasibility group; 2 out of 10 in the higher-dose ALL efficacy group; 2 out of 7 in the higher-dose AML feasibility group; 19 out of 42 in the higher-dose AML efficacy group; and 2 out of 2 in a small group with an ambiguous leukaemia type. For the secondary outcome measuring serious side effects (graded as severe or worse on a standard scale), the reported data shows that serious adverse events of this level were recorded in 7 of 8, 2 of 2, 3 of 3, 10 of 10, 7 of 7, 35 of 42, and 2 of 2 participants across the respective groups. A third planned secondary outcome — a laboratory analysis of gene activity related to cell death — had no numerical results reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01998880 · results posted 28 January 2014

    According to the results reported on ClinicalTrials.gov, this trial (NCT01998880) enrolled 351 people with chronic lymphocytic leukaemia (CLL) — 233 in the group receiving rituximab combined with chlorambucil (RClb), and 118 in the group receiving chlorambucil alone (Clb). The trial's main goal was to measure "progression-free survival" — that is, how long participants went without their disease worsening, coming back, or dying from any cause. Secondary goals included how long participants lived overall, how long they remained free of any new treatment, and how many showed a measurable response to treatment. The reported data shows that, for the primary outcome of progression-free survival, the median time (the point at which half of participants in each group had experienced a worsening event) was 16.5 months in the RClb group and 11.1 months in the Clb group. The reported data also shows that, over the full follow-up period, approximately 90% of participants in both groups eventually experienced a progression, relapse, or death event (90.1% in RClb and 90.7% in Clb). For overall survival, the median time was reported as 74.9 months in the RClb group and 66.7 months in the Clb group. Regarding treatment response at the end of treatment, a complete response was reported in 4.7% of the RClb group and 0% of the Clb group, while a partial response was reported in 55.4% of the RClb group and 28.8% of the Clb group. Molecular remission — meaning no detectable disease cells in blood or bone marrow samples — was reported in 2% of the RClb group and 0% of the Clb group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01361464 · results posted 6 January 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 21 people, all of whom had Acute Myelogenous Leukaemia (a type of blood cancer). Every participant received the study drug R115777 (also called Zarnestra). The trial was specifically looking at people whose bone marrow samples showed a particular pattern in two genes, which researchers hoped might predict who would respond to this treatment. Of the 21 who started, 18 completed the study and 3 did not. The reported data shows that the main thing being measured was the rate of "complete remission" — meaning no detectable leukaemia cells remaining, with blood counts returning to a healthy range. According to the results reported on ClinicalTrials.gov, 11% of participants achieved this, which in a group of 21 people represents roughly 2 individuals. For the secondary outcomes, the reported median overall survival (the midpoint survival time across the group) was 6.6 months, measured from the first day of treatment. The reported data shows that 2 participants had relapse-free survival — meaning 2 people who reached complete remission did not experience a return of their disease or die during the follow-up period. The one-year survival rate was not reported, as the study was stopped early after it did not meet its target of at least 3 participants reaching remission after two treatment cycles. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00322101 · results posted 28 October 2013

    According to the results reported on ClinicalTrials.gov, this trial enrolled 25 people in total — 14 in one group that received a lower-intensity ("nonmyeloablative") conditioning regimen before a stem cell transplant, and 11 in a group that received a higher-intensity ("myeloablative") conditioning regimen. All 25 participants completed the study. The trial was measuring a range of outcomes including how many people were still alive at the end of follow-up, whether the disease stayed under control, whether donor cells successfully established themselves in the body, and whether participants experienced a complication called graft-versus-host disease (where donated cells can react against the recipient's body). The reported data shows that in the primary outcome — overall survival — 6 out of 14 participants in the lower-intensity group and 6 out of 11 in the higher-intensity group were alive at the time results were recorded. For progression-free survival (meaning the disease had not worsened), 7 out of 14 in the lower-intensity group and 5 out of 11 in the higher-intensity group met this measure. The reported data shows that donor cells successfully established in the body ("engraftment") in 11 out of 14 participants in the lower-intensity group and all 11 out of 11 in the higher-intensity group. Disease progression or relapse was recorded in 7 out of 14 in the lower-intensity group and 2 out of 11 in the higher-intensity group. Graft-versus-host disease was recorded in 1 out of 14 participants in the lower-intensity group and 4 out of 11 in the higher-intensity group. Non-relapse mortality (deaths not caused by the disease returning) was reported as zero in both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00098670 · results posted 3 December 2012

    According to the results reported on ClinicalTrials.gov, this trial enrolled 102 participants, all of whom completed the study. The trial was measuring how people with a blood cancer (chronic lymphocytic leukaemia) responded to a two-step treatment approach: first receiving a combination of two medicines called fludarabine and rituximab, and then receiving a consolidation (follow-up) treatment with a third medicine called alemtuzumab. The main thing the researchers were looking at was how many participants achieved what is called a "complete response" — meaning no detectable signs of disease in the blood, lymph nodes, or bone marrow after the full course of treatment. The reported data shows that, after the initial phase of treatment with fludarabine and rituximab, 92 out of 102 participants showed either a complete or partial response (a partial response meaning a meaningful reduction in disease signs, though not complete clearance). After the follow-up alemtuzumab treatment, 38 out of 102 participants were reported to have achieved a complete response. The reported data also shows that, at the two-year mark, an estimated 72% of participants were alive and had not seen their disease progress, and an estimated 86% of participants were alive overall. These two figures were calculated using a statistical method called Kaplan-Meier estimation, which is a standard way of tracking survival over time in a group. Additionally, 23 out of 102 participants were reported to have experienced severe side effects (rated as serious or life-threatening on a standard scale) that were considered at least possibly related to the alemtuzumab treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00071006 · results posted 19 March 2012

    According to the results reported on ClinicalTrials.gov, this trial enrolled 12 participants, all of whom received a medicine called axitinib. The trial was studying people with certain blood cancers — specifically acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS). The main thing the researchers were measuring was whether participants' cancer showed a meaningful response to the treatment, defined by specific changes in bone marrow and blood cell counts. Secondary measurements included things like how long any response lasted, changes in blood vessel growth within the bone marrow, and levels of certain proteins in the blood. The reported data shows that none of the 12 participants (0%) met the criteria for an objective response — meaning no one achieved either a complete or partial remission as defined by the study. Notably, the data also shows that none of the 12 participants completed the study, though the reasons for this are not detailed in the submitted results. For all of the secondary outcome measures — including blood cell improvements, duration of response, bone marrow blood vessel density, and protein level changes — no numerical results were reported to ClinicalTrials.gov, so those figures are not available. Because the trial ended with no participants completing it and no secondary data submitted, the picture from this study is very limited. The reported data shows only that the primary response rate was 0% among the 12 people who started the trial; beyond that, the submitted results do not provide further detail. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00090051 · results posted 23 January 2012

    According to the results reported on ClinicalTrials.gov, this trial enrolled 276 people in each of two groups — a total of 552 participants — all of whom had a type of blood cancer called chronic lymphocytic leukaemia. One group received two chemotherapy medicines together (fludarabine and cyclophosphamide, called FC), and the other group received those same two medicines plus a third medicine called rituximab (called FCR). The trial was mainly measuring how long participants went without their disease getting worse (called "progression-free survival"), and also tracked how long participants lived overall and how long before any major setback occurred. The reported data shows that, for the main measure — time without disease getting worse as judged by an independent review panel — the FC group had a reported median (middle value) of 660 days, while the FCR group had a reported median of 813 days. In terms of how many people experienced a worsening of their disease or death during the study, the reported data shows 148 people in the FC group and 137 in the FCR group had such an event. For overall survival (time until death from any cause), the FC group had a reported median of 1,580 days; a median figure for the FCR group was not reported in the data. The number of deaths recorded was 68 in the FC group and 62 in the FCR group. For the additional measure of "event-free survival" — which also counted starting a new treatment as an event — the reported medians were 586 days for FC and 874 days for FCR. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00416884 · results posted 2 August 2011

    According to the results reported on ClinicalTrials.gov, this trial enrolled only one participant. The study was looking at a bone marrow transplant preparation approach combining whole-body radiation, a medicine called Campath, and a chemotherapy drug called Fludarabine, with a process to reduce certain immune cells (T-cells) before the transplant. The trial was tracking treatment-related mortality — meaning deaths linked to the treatment itself, which can occur due to complications from the preparation process (such as organ failure, serious infections, or bleeding) or from a serious immune reaction called graft versus host disease, where transplanted cells attack the recipient's body. The reported data shows that the one participant who entered the trial did not complete it, though the reason for not completing was not detailed in the data provided. For the primary outcome — the number of participants who died from treatment-related causes — the reported figure was zero out of the one participant enrolled. Because only one person took part in this trial, the reported data is extremely limited and no broader conclusions can be drawn from these numbers alone. Any figures relating to secondary outcomes were not reported in the data available on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00392782 · results posted 15 July 2011

    According to the results reported on ClinicalTrials.gov, this trial enrolled 24 participants, all of whom completed the study. The trial was looking at what happened to patients after a bone marrow (stem cell) transplant from a donor. It measured things like how many patients were alive and free of their disease one year after the transplant, as well as a number of possible complications in the period following the procedure. The reported data shows that at the one-year mark, 18 out of 24 participants were alive and without disease — this was the main measure the trial was tracking. Of the remaining participants, 6 out of 24 had experienced a return of their disease by the one-year point, and 8 out of 24 deaths were recorded as being related to the transplant procedure itself within that same timeframe. For complications: 6 out of 24 participants developed a moderate-to-life-threatening form of a condition called acute graft-versus-host disease (where transplanted immune cells can react against the recipient's body) within the first 100 days; 4 out of 24 developed a longer-lasting version of this same condition by one year; and 1 out of 24 participants experienced graft failure, meaning the transplanted cells did not successfully take hold within the expected timeframe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00480987 · results posted 30 June 2011

    According to the results reported on ClinicalTrials.gov, this trial involved 27 adults who received a combination of three medicines — oxaliplatin, cytarabine, and fludarabine. All 27 participants completed the study. The trial was measuring how many people had an "objective response" to the treatment, which means whether their blood cancer showed signs of improvement based on specific counts of blood cells and bone marrow findings. The reported data shows that out of the 27 participants, 3 people achieved what was defined as a "complete response" — meaning their bone marrow and blood cell counts met certain recovery targets. A further 2 people achieved what was called a "complete response without full platelet recovery," where most targets were met except for platelet counts (platelets are tiny blood cells that help with clotting). No participants were recorded as having a "partial response," which would have meant at least a 50% reduction in abnormal bone marrow cells along with some blood count recovery. The data was not reported in a way that shows what happened beyond these response categories. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00904995 · results posted 12 May 2011

    According to the results reported on ClinicalTrials.gov, this trial involved 21 people split into two groups: 10 people in Group 1, who received an oral (by mouth) treatment, and 11 people in Group 2, who received a treatment given through a drip into a vein (IV) followed by oral treatment. All 21 participants completed the study with no drop-outs. The trial was measuring levels of a substance in the blood called beta-d-glucan (BG) — a marker that can indicate the presence of a type of serious fungal infection. Blood samples were taken before and at several time points after the first dose on each of the first two days of treatment. The reported data shows the percentage of blood samples where BG levels were above 60 pg/ml (picograms per millilitre — a very small unit of measurement used to detect tiny amounts of a substance). For Group 1 (Oral), the reported figures were 4% and 3% of samples across the two measurement days. For Group 2 (IV + Oral), the reported figures were 5% and 3% of samples across the two days. It is worth noting that the data as submitted does not include further detail on how these figures relate to each specific time point or day, so only these summary percentages are available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00519090 · results posted 10 May 2011

    According to the results reported on ClinicalTrials.gov, this trial was comparing two medications — nilotinib and imatinib — in people who had a type of leukaemia and had not responded as well as hoped to imatinib treatment. The trial aimed to measure how many participants achieved a "complete cytogenetic response" (meaning no signs of the abnormal chromosome linked to the disease could be detected in blood or bone marrow tests). A total of 6 people were enrolled — 2 in the nilotinib group and 4 in the imatinib group — and all 6 completed the study period. The reported data shows that the trial was stopped early, and because of this, the numbers of participants in each group were too small and unevenly distributed for any meaningful analysis to be carried out. As a result, no figures were reported for either the primary outcome (the rate of complete cytogenetic response) or the secondary outcome (how long that response lasted, known as a "durable" response). The trial's own notes state that analysis was not performed due to these limitations. Because the trial ended before enough participants could be recruited, the reported data does not provide figures that allow any conclusions to be drawn about how the two treatments compared. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00281918 · results posted 29 March 2011

    According to the results reported on ClinicalTrials.gov, this trial enrolled 817 people in total — 409 in one group and 408 in another. Participants were randomly assigned to receive either a two-drug combination called FC (fludarabine and cyclophosphamide) or a three-drug combination called FCR (the same two drugs plus rituximab). The trial was measuring how long people went without their condition getting worse or returning, as well as how long they survived overall. The reported data shows that the main measure — called progression-free survival, meaning the length of time before the disease worsened, came back, or a person died — was reported as a median (the middle value when all results are lined up) of 981 days for the FC group and 1,212 days for the FCR group in an earlier analysis. In a later, final analysis, the reported figures were 998 days for the FC group and 1,703 days for the FCR group. For overall survival (how long people lived), the final analysis reported a median of 2,613 days for the FC group; a median figure for the FCR group was not reached, meaning not enough people in that group had died by the time the data was collected for a number to be calculated. For a secondary measure called event-free survival — which also counted starting a new treatment as an event — the reported medians were 947 days (FC) and 1,212 days (FCR). The reported data also shows results for people who achieved a complete response (where all measurable signs of disease temporarily disappeared). The number of people who reached that point was not reported in the data provided here, so that figure cannot be described. Among those who did achieve a complete response, the time before their disease returned or they died was not fully calculable, as a median was not reached in either group within the observation period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00481247 · results posted 15 March 2011

    According to the results reported on ClinicalTrials.gov, this trial compared two medicines — dasatinib and imatinib — in people newly diagnosed with a type of blood cancer called chronic myeloid leukaemia (CML). A total of 259 people were assigned to the dasatinib group and 260 to the imatinib group, with 258 in each group actually receiving treatment. The trial's main goal was to measure how many participants achieved a "complete cytogenetic response" — meaning that when bone marrow cells were examined under a microscope, no abnormal cancer-related chromosomes (called Philadelphia-positive cells) could be detected — and that this result held up on repeat testing within 12 months. The reported data shows that, for the primary goal, 204 out of 259 participants in the dasatinib group and 177 out of 260 in the imatinib group achieved this confirmed response within 12 months. For the secondary measurements, the reported data shows that the median time to first reaching this response was 3.1 months in the dasatinib group and 5.8 months in the imatinib group. A separate molecular measure (looking at levels of a specific gene signal in the blood) was recorded in 76.4% of dasatinib participants and 64.2% of imatinib participants at any point during the trial, with median times to reaching that milestone of 9.3 months and 15.0 months respectively. The percentage of participants who remained free from disease progression over the study period was reported as 88.9% (dasatinib) and 89.2% (imatinib). The reported data also shows that among those who did achieve the confirmed cytogenetic response, the percentage still maintaining that response was tracked over several years: at the two-year mark, 98.0% (dasatinib) and 96.9% (imatinib); at three years, 96.9% and 95.7%; at four years, 95.6% and 95.7%; and at five years, 93.1% and 91.0%. It is worth noting that the trial records show zero participants listed as formally "completing" the study under the standard completion milestone, which may reflect how study exit was categorised — this detail was not further explained in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00253513 · results posted 11 February 2011

    According to the results reported on ClinicalTrials.gov, this trial enrolled 60 participants, all of whom completed the study. Every participant received the same treatment — a conditioning regimen (a preparatory treatment given before a bone marrow transplant) combining two medicines called treosulfan and fludarabine. The trial was primarily measuring serious side effects affecting major organs, graft failure (whether the transplanted cells successfully took hold), and deaths not caused by the original disease returning. A secondary measure looked at how many participants were free of their disease after one year. The reported data shows that 2 participants experienced serious side effects affecting major organ systems (such as the heart, kidneys, lungs, liver, nervous system, or digestive system) in an earlier phase of the study, and 5 participants experienced such side effects in a later phase. Regarding graft-related complications, 36 participants were reported as having a result in one measurement category and 31 in another — however, the data as submitted does not clearly label which figures correspond to graft failure versus graft-versus-host disease (a condition where transplanted donor cells attack the recipient's body), so these specific breakdowns cannot be stated with certainty. For deaths not related to the disease returning, the reported data shows this occurred in 5% of participants by day 200 in the secondary phase. The secondary outcome reported that 58 out of 60 participants were recorded as being without their disease at the one-year mark. It is worth noting that because some of the submitted data labels are not fully detailed, a complete picture of every individual measurement cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00101647 · results posted 2 March 2010

    According to the results reported on ClinicalTrials.gov, this trial enrolled 174 people in total — 13 who had stopped taking the drug imatinib because they could not tolerate its side effects (the "imatinib-intolerant" group), and 161 whose disease had stopped responding to imatinib (the "imatinib-resistant" group). The trial was measuring how participants' blood counts responded to the study treatment, using two main response categories: a "major haematologic response" (MaHR — meaning blood counts returned to near-normal levels) and an "overall haematologic response" (OHR — a broader category that also included a lesser degree of improvement). All 174 participants who started the trial also completed it. The reported data shows that, looking at MaHR, 9 out of 13 people in the imatinib-intolerant group and 103 out of 161 in the imatinib-resistant group met that measure. For the broader OHR category, the numbers were 12 out of 13 and 127 out of 161 respectively. Among those who achieved a MaHR, the trial also tracked how many had maintained that response without their disease getting worse over time (using a statistical method called Kaplan-Meier estimation, which estimates the proportion still in response at a set point in time). At 12 months, the reported figures were approximately 85.7% of MaHR responders in the imatinib-intolerant group and 78.3% in the imatinib-resistant group. At 24 months, a figure was only reported for the imatinib-resistant group: approximately 60.9%. For the broader OHR category, the reported proportions still in response at 12 months were around 69.8% in both groups, and at 24 months approximately 34.9% (imatinib-intolerant) and 51.2% (imatinib-resistant). The reported data also shows that the middle point in time (median) for reaching a MaHR was 84 days in the imatinib-intolerant group and 63 days in the imatinib-resistant group, while the median time to reaching the broader OHR was 34 days and 30 days respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00101816 · results posted 2 March 2010

    According to the results reported on ClinicalTrials.gov, this trial enrolled 109 people in total — 10 who could not tolerate a medicine called imatinib (described as "imatinib-intolerant") and 99 whose leukaemia had stopped responding to imatinib (described as "imatinib-resistant"). All 109 participants completed the study. The trial was measuring how their blood cell counts responded to the study treatment, looking at two levels of blood response — a "major" response (where blood counts returned to near-normal levels) and an "overall" response (which also included a lesser, "minor" improvement in counts). It also tracked how long any response lasted, how quickly it appeared, and whether changes were seen in the chromosomes of leukaemia cells. The reported data shows that, across both groups combined, 36 out of 109 participants recorded a major blood response and 54 out of 109 recorded an overall blood response (including both major and minor responses). Among those who achieved a major response, the median duration — that is, the middle value of how long the response lasted — was reported as 22.4 months, while for those with an overall response it was 14.7 months. The median time from first dose to achieving a major response was reported as 63.5 days, and to achieving an overall response was 30 days. On the chromosome-level measure, 29 out of 109 participants showed a complete cytogenetic (chromosome) response, 8 showed a partial response, 3 a minor response, and 11 a minimal response; the remaining participants showed no cytogenetic response. Regarding blood count categories, 28 participants recorded a complete or "no evidence of leukaemia" response, 8 recorded a minor response, 18 recorded some response, and 55 recorded no hematologic (blood) response. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00101660 · results posted 24 February 2010

    According to the results reported on ClinicalTrials.gov, this trial enrolled 387 people with a type of blood cancer (chronic myeloid leukaemia) who had previously been treated with a drug called imatinib. Participants fell into two groups: 99 people who had stopped imatinib because they could not tolerate it (imatinib-intolerant), and 288 people whose cancer had stopped responding to imatinib (imatinib-resistant). All participants received dasatinib at a dose of 70 mg twice daily. The trial was measuring how many participants showed a particular type of response in their bone marrow — called a Major Cytogenetic Response (MCyR), which means the proportion of abnormal cancer-related cells in the bone marrow fell to 35% or below. The reported data shows that, among the imatinib-resistant group, 159 out of 288 participants recorded an MCyR. In the imatinib-intolerant group, 81 out of 99 participants recorded an MCyR. The trial also tracked how long those responses lasted. Among participants who achieved an MCyR, the reported data shows that approximately 98.5% and 93.7% had not progressed at 12 and 24 months respectively in one subgroup, and 96.7% and 83.6% in the other (the data as submitted does not clearly label which figure belongs to which group for these time points). The median time for participants to first achieve an MCyR was reported as approximately 2.79 months in one group and 2.92 months in the other. Separately, the trial measured a blood-based marker called Complete Haematologic Response (CHR); the reported data shows 93 participants in one group and 259 in the other recorded this response, with the majority maintaining it at both the 12- and 24-month marks. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00103844 · results posted 7 January 2010

    According to the results reported on ClinicalTrials.gov, this trial enrolled 150 people with a type of leukaemia who had previously been treated with imatinib (a medicine for leukaemia) but whose disease had stopped responding to it. Participants were split into two groups: 101 people received dasatinib first, and 49 people received imatinib first. The trial was measuring how well each treatment reduced the number of abnormal cancer-related chromosomes (called Philadelphia chromosome-positive cells) in the bone marrow — a response known as a "major cytogenetic response" (MCyR). Some participants later crossed over to the other treatment. The reported data shows that, at the 12-week mark, 36 out of 101 participants in the dasatinib group and 14 out of 49 in the imatinib group had a major cytogenetic response. Looking at any point before participants crossed over to the other treatment, the reported numbers show 54 dasatinib participants and 16 imatinib participants achieved a major cytogenetic response overall. Among those who did achieve this response, the reported data shows that at both 12 and 18 months, 92% and 90% of dasatinib responders had maintained that response without their disease progressing, compared with 74% of imatinib responders at both time points. At 24 months, 90% of dasatinib responders had maintained their response; the equivalent imatinib figure was not reported in the data. The median time to first achieving a major cytogenetic response was reported as 2.8 months in both groups. Separately, a measure of blood cell counts returning to a normal range (called a complete haematologic response) was reported in 94 dasatinib participants and 40 imatinib participants at any point before crossover. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.