A Study of Azacitidine and Venetoclax Versus a Stem Cell Transplant in People 65 Years and Older With Acute Myeloid Leukemia
Trial Parameters
Brief Summary
The researchers are doing this study to find out if an allogeneic hematopoietic stem cell transplant (HSCT) or maintenance therapy with azacitidine and venetoclax is more effective at keeping AML from coming back (relapsing).
Eligibility Criteria
Inclusion Criteria: * Adult patients ≥65 years of age at the time of signing the informed consent form. * Confirmed diagnosis of acute myeloid leukemia according to the ELN 2017 criteria * Treatment with azacitidine and venetoclax for the diagnosis of AML o The first cycle of study treatment will start 28-42 days after the start of the second cycle of SOC AZA/VEN. In the event that patients can't be admitted for allo-HCT until after Day 42 due to donor related issues, an additional cycle of AZA/VEN will be allowed as a bridge to the transplant, and then initiation of conditioning will start no later than day 42 after the start of the third cycle. * Patients with adequate organ function to be considered as candidates for allo-HCT: * Cardiac: asymptomatic or if symptomatic, then LVEF at rest must be \>40% and must improve with exercise. * Renal: CrCl ≥50 ml/min (measured or calculated/estimated). * Pulmonary: asymptomatic or if symptomatic, DLCO \> 50% of predicted (corrected for hemoglo