Phase 1 Leukaemia Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Children and young people aged 21 or younger at the time of joining both the screening stage and the treatment stage of the trial (note: people who turn 22 between the screening and treatment stages would not meet this criterion).
• People who have been diagnosed with a new high-risk form of acute myeloid leukaemia (AML), AML that developed after previous cancer treatment, or AML that has come back or has not responded to treatment — and whose leukaemia is in complete remission (no signs of active disease) at the time of the bone marrow transplant.
• People whose AML has previously spread to the brain/spinal fluid or other areas outside the bone marrow may still meet this criterion, provided there is no sign of active disease in those areas at the time of joining, and that the leukaemia is in complete remission at the time of transplant.
• People who are planning to have a bone marrow sample sent to a specialist laboratory (Hematologics) within 14 days before starting the transplant preparation treatment.
• People who are having their first allogeneic bone marrow transplant (a transplant using cells from a donor — related, unrelated, or partially matched, including half-matched family donors), using bone marrow, blood stem cells, or cord blood.
• People whose transplant preparation (conditioning) treatment is planned to begin within 14 days after the bone marrow disease assessment.
• People whose transplant preparation treatment is a full-intensity (myeloablative) regimen that includes high-dose busulfan, treosulfan, or full-body radiation.
• People who have not previously received the study drug ASTX727 (note: prior exposure to a related drug called decitabine alone is acceptable).
• People living with HIV may meet the criteria if: there is no history of serious HIV-related complications (other than a previously low CD4 count); the HIV viral load has been undetectable within the last 6 months; the CD4 count was above 500 cells/mm³ before the AML diagnosis; no HIV medications are being taken that could interact with the study drug or suppress bone marrow; and there is no history of treatment-resistant HIV.
• At the treatment stage, people with a body surface area (a measure of body size) of at least 1 square metre.
• At the treatment stage, people whose AML is confirmed to be in complete remission with no detectable residual disease, based on a specialist bone marrow test performed within 14 days before starting the treatment stage.
• People who are reasonably well and able to carry out daily activities, as measured by standard medical scoring tools (confirm with trial site for specific score thresholds).
• People who have fully recovered from the side effects of the transplant preparation and transplant itself, generally assessed between 42 and 100 days after the transplant.
• People with adequate blood counts at the treatment stage: platelet count at or above a specified level without needing a platelet transfusion in the past 7 days; haemoglobin (red blood cell measure) at or above a specified level (transfusions are permitted); and neutrophil count (infection-fighting white blood cells) at or above a specified level without recent use of growth factor medications.
• People with adequate kidney function, measured by specific approved methods (confirm with trial site for which kidney function test is acceptable).
• People with liver function blood test results within acceptable ranges at the treatment stage (confirm with trial site for specific values).
• People with an albumin (blood protein) level of at least 2 g/dL.

Who may not be able to join:

• People with known inherited bone marrow failure conditions, such as Fanconi Anaemia, Dyskeratosis Congenita, or Shwachman-Diamond Syndrome.
• People with a known or suspected allergic reaction to filgrastim, decitabine, or cedazuridine (ASTX727).
• People who have previously received a solid organ transplant (such as a kidney or liver transplant).
• People who are pregnant, breastfeeding, or not willing to use two effective forms of contraception during the study and for a specified period after the last dose of study drug; pregnancy testing is required for females who have started their menstrual periods.
• People who are currently taking another experimental (investigational) drug.
• People who are currently receiving other anti-cancer treatments, with the exception of chemotherapy injected directly into the spinal fluid within the prior 14 days.
• People for whom other anti-cancer treatments, radiation, or immunotherapy are planned during the study period (note: certain medications used to prevent graft-versus-host disease are permitted, as is spinal fluid chemotherapy given at the treating doctor's discretion during maintenance therapy).
• People who are taking certain medications that interact with the study drug on the days ASTX727 is given and for 24 hours after — this includes a specific list of drugs processed by the same enzyme as the study drug (confirm with trial site for the full list).
• People who are unable to swallow tablets whole; the study drug cannot be given through a nasal or stomach tube.
• People who would not be able to start the study treatment between 42 and 100 days after the transplant.
• People whose transplanted cells have failed to take hold (graft loss).
• People with severe graft-versus-host disease (a condition where donor cells attack the body) that has not responded to steroid treatment, or who require high doses of steroids that are not being reduced, or who are receiving second-line treatments for this condition.
• People with an active infection (viral, bacterial, fungal, or parasitic) that is not under control.
• People with an active transplant-related blood vessel condition causing ongoing red blood cell breakdown that requires treatment (confirm with trial site).
• People with an active liver condition related to the transplant that still requires ongoing treatment (confirm with trial site).
• People with active non-infectious lung inflammation that requires ongoing treatment or supplemental oxygen.
• People who, in the opinion of the trial team, may not be able to safely follow the monitoring requirements of the study.

Important: Always verify eligibility with the trial site directly before applying.