Phase 3 Leukaemia Trial, Recruiting

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

Who might be able to join this trial:

Phase II (for people aged 18 to 70):

• People aged 18 to 70 years, including those who speak languages other than English
• People diagnosed with acute myeloid leukaemia (AML) who have already received initial treatment, and who also have at least one higher-risk feature — such as a high-risk genetic profile, detectable remaining disease after treatment, disease that has not gone into remission or has come back, AML that developed from another blood condition, or AML caused by previous cancer treatments
• People diagnosed with myelodysplastic syndrome (MDS) or a related blood condition called CMML, with at least one higher-risk feature — such as poor genetic risk results, certain gene mutations, a high-risk score on a standard assessment tool, 5% or more abnormal cells in the bone marrow at the time of transplant, or MDS caused by previous cancer treatments
• People who have a suitable bone marrow donor available — this may be a fully matched sibling, a mostly matched unrelated donor (at least 7 out of 8 markers), or a half-matched related donor
• People who are willing to sign a consent form agreeing to take part
• Women who could become pregnant must have a negative pregnancy test result before joining
• People whose liver is functioning adequately, shown by blood test results within acceptable ranges for liver enzymes (AST and ALT below 3 times the upper limit of normal) and bilirubin (below 1.5 times the upper limit of normal, with some exceptions)
• People whose kidneys are functioning adequately, shown by a kidney filtration rate of at least 50 mL/min (confirm with trial site for how this is measured)

Phase III (for people aged 18 to 65):

• People aged 18 to 65 years, including those who speak languages other than English
• People diagnosed with AML who have already received initial treatment and have at least one higher-risk feature — similar to Phase II, and also including people in a second or later remission
• People diagnosed with MDS with at least one higher-risk feature — including certain gene mutations, high-risk scores on standard assessment tools, poor genetic risk results, 5% or more abnormal cells in the bone marrow, or MDS caused by previous cancer treatments
• People diagnosed with CMML
• People who have a suitable bone marrow donor available — a fully matched sibling or a mostly matched unrelated donor (at least 7 out of 8 markers) (note: half-matched donors are not listed as an option in Phase III — confirm with trial site)
• People who are willing to sign a consent form agreeing to take part
• Women who could become pregnant must have a negative pregnancy test result before joining
• People whose liver and kidneys are functioning adequately, as described under Phase II above

Who may not be able to join:

• People who are known to be HIV positive
• People who have cognitive (thinking or memory) difficulties, or who are currently in prison
• People whose AML is specifically the type called acute promyelocytic leukaemia
• People whose AML has spread to the brain or spinal cord (the central nervous system)
• People with an active, uncontrolled infection (viral, bacterial, or fungal)
• People with ongoing hepatitis B or hepatitis C infection that requires treatment (some people with past hepatitis B exposure or certain antibody results may still be eligible — confirm with trial site)
• People with a significant heart condition, including heart failure requiring treatment, a heart pumping function below 50%, or unstable chest pain (angina)
• People with significantly reduced lung function, based on specific breathing test results falling below required levels (confirm with trial site)
• People who have consumed grapefruit, grapefruit products, Seville oranges (including marmalade made with Seville oranges), or star fruit within 3 days before the first dose of the study drug
• People with serious unstable medical conditions or mental health conditions that could affect safety or the ability to give informed consent or follow study procedures
• People who have previously had an allogeneic stem cell transplant (a transplant using cells from another person)

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