Trial 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
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.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Leukaemia Trial, Completed
Who may be able to join
AI generated eligibility 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
Who might be able to join this trial:
- People aged 18 or older at the time of signing the consent form
- People who have been formally diagnosed with Myelodysplastic Syndromes (MDS), classified using a specific medical system called the FAB classification
- People who have already received an adequate course of treatment with an injectable drug called azacitidine or decitabine as their most recent MDS treatment — "adequate" means at least 6 cycles of azacitidine, or at least 4–6 cycles of decitabine depending on the regimen used, or at least 3 months of attempted treatment if serious side effects prevented completion
- People whose MDS either did not respond to (or got worse during) that previous injectable treatment — those whose disease responded well to it would not meet this criterion
- People whose last dose of the previous injectable treatment was no more than 16 weeks before the start of screening for this trial
- People whose last dose of the previous injectable treatment was at least 3 weeks before the planned first dose of the trial treatment
- People with a general health and activity level rated 0, 1, or 2 on a standard medical scale (meaning broadly able to carry out daily activities, with or without some limitations) (confirm with trial site)
- Women who could become pregnant, provided they meet specific pregnancy testing and contraception requirements outlined by the trial site
- Men, provided they agree to specific contraception and sperm donation restrictions during and after the trial
- People who are able to understand and sign an informed consent form voluntarily before any trial procedures begin
- People who are able to follow the trial visit schedule and all other trial requirements
- People who are able to understand and sign a separate consent form specifically for biomarker-related procedures
Who may not be able to join:
- People whose MDS is rapidly progressing, defined as a significant doubling of blast cells in the bone marrow or blood (reaching 20% or more), or a doubling of certain white blood cell counts, in the 8 weeks before the planned first treatment date
- People who have developed acute myeloid leukaemia (AML), defined as having 30% or more blast cells in the bone marrow (the trial may allow up to 33% in limited circumstances — confirm with trial site)
- People who have previously had a stem cell transplant from a donor
- People who have previously received an oral (tablet) form of decitabine or any other oral azacitidine-type drug at any point
- People whose MDS previously responded well to injectable azacitidine or decitabine at any time in their history, including people who later relapsed
- People who are still experiencing significant side effects from a previous treatment, regardless of how long ago that treatment was
- People who have used certain blood cell–stimulating drugs (such as romiplostim, eltrombopag, interleukin-11, erythropoiesis-stimulating agents, or interleukin-3) within 28 days before the planned first trial treatment dose
- People currently using corticosteroid medications, unless the dose has been stable or decreasing for at least 1 week and is being used for a condition other than MDS
- People with a history of inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), coeliac disease, stomach removal surgery, or any other gut condition that could affect how the trial drug is absorbed or processed
- People with a history of another cancer within the past 3 years — with exceptions for certain early-stage or surface skin cancers, early cervical or breast changes, or a specific low-grade finding of prostate cancer (confirm with trial site)
- People who have had significant heart problems in the past 6 months, including severe heart failure, unstable chest pain, or a heart attack
- People with an active, uncontrolled infection (bacterial, fungal, or viral) that is not improving with appropriate treatment
- People known to have HIV or Hepatitis C infection, or an active Hepatitis B infection
- People with certain abnormal blood or liver test results, including elevated liver enzymes, elevated bilirubin (with some exceptions), elevated creatinine (a kidney marker), or a very high white blood cell count (confirm specific thresholds with trial site)
- People known to be allergic or sensitive to azacitidine, mannitol, or related substances, or to certain types of antibody-based medications
- Women who are pregnant, planning to become pregnant (from 28 days before starting treatment through to at least 90 days after the last dose), or currently breastfeeding
- People with any significant medical condition, abnormal test result, or mental health condition that could prevent safe participation in the trial
- People with any condition that places them at unacceptable risk if they were to participate
- People with any condition (other than MDS) that could cause anaemia and make it hard to interpret trial results accurately
- People who have previously received certain immunotherapy drugs targeting CTLA-4, PD-1, or PD-L1, or who have received other experimental antibody-based treatments within the past 6 months
- People showing signs of leukaemia affecting the brain, spinal cord, or lungs
- People with an active or recent history (within the past 3 years) of autoimmune or inflammatory conditions such as lupus, rheumatoid arthritis, myasthenia gravis, Graves' disease, severe inflammatory bowel disease, or similar — with exceptions for vitiligo, hair loss (alopecia), well-controlled hypothyroidism, or mild psoriasis not requiring systemic treatment
- People with a history of a primary immune system deficiency disorder
- People with active myeloproliferative neoplasms or a condition called chronic myelomonocytic leukaemia (CMML)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Bristol-Myers Squibb, Bristol-Myers Squibb
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
9 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Overall Response Rate Based on the Modified International Working Group (IWG) 2006 Response Criteria for Myelodysplastic Syndrome (MDS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.