Phase 2 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:

• People aged 18 or older at the time of signing the consent form (a legally authorised representative may sign on someone's behalf).
• People who are willing and able to attend scheduled study visits and follow the study requirements.
• People who have been diagnosed with a newly diagnosed form of acute myeloid leukaemia (AML) — but not the subtype called acute promyelocytic leukaemia (APL) — confirmed according to 2022 World Health Organization guidelines. All other AML subtypes are permitted regardless of risk level or gene mutations.
• People who have completed 1 to 3 cycles of intensive chemotherapy to try to achieve remission.
• People whose bone marrow test shows they are in remission, meaning fewer than 5% abnormal (blast) cells are detected.
• People whose blood counts have recovered fully or partially after chemotherapy (complete remission, or complete remission with partial blood count recovery).
• People whose leukaemia still shows detectable traces of disease (called measurable residual disease or MRD) above a certain threshold on specialised testing.
• People whose treating doctor considers them fit enough to receive intensive chemotherapy and to proceed to a stem cell transplant from a donor after the trial treatment.
• People with an acceptable general fitness level, as measured by a standard medical scale (ECOG score of 3 or below).
• People with adequately functioning liver and kidneys, based on blood test results within specified ranges.
• People who do not have an active, uncontrolled infection, heart failure, or severe psychiatric or neurological condition.
• Women who could become pregnant must have a negative pregnancy test before starting treatment and again within two weeks of starting.
• Women who could become pregnant must use effective contraception during the study and for 6 months after the last dose of the study drug azacitidine. Men with female partners who could become pregnant must use effective contraception during treatment and for 3 months after.

Who may not be able to join:

• People who have the APL subtype of leukaemia, or whose AML has returned or stopped responding to treatment.
• People whose AML has developed from a condition called chronic myeloid leukaemia entering a "blast crisis" phase.
• People whose bone marrow test shows 5% or more abnormal (blast) cells.
• People who have previously been treated with a medicine called venetoclax.
• People who have another medical condition that, in the treating doctor's opinion, would make participation unsafe or unsuitable.
• People with an active, uncontrolled infection caused by a fungus, bacteria, or virus.
• People who have had a serious blood clot in a vein or artery recently — for example, a pulmonary embolism (clot in the lungs) within the past 30 days, or a drug-eluting heart stent placed within the past 6 months. People already on blood-thinning medication for a heart rhythm condition called atrial fibrillation may still be considered if their stroke risk score is below a certain threshold (confirm with trial site).
• People who have a mechanical (artificial) heart valve.
• People who have had a recent serious bleeding episode, based on the treating doctor's assessment.
• People who have had significant active heart disease within the 6 months before starting the study.
• People who have difficulty swallowing, or a digestive condition that would prevent them from properly absorbing oral (swallowed) medication.
• People who are pregnant or breastfeeding.

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