A Study of Azacitidine and Venetoclax Versus a Stem Cell Transplant in People 65 Years and Older With Acute Myeloid Leukemia

Inclusion Criteria16

• 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 hemoglobin)
• Hepatic: \< 5x ULN liver function tests and \< 2x ULN total serum bilirubin, unless there is congenital benign hyperbilirubinemia.
• KPS of ≥ 70
• Patients with suitable donor for allo-HCT
• Patients must achieve a morphologic remission \<5% blast with MRD negative status by flow cytometry (defined as one or less residual leukemic blasts per 1000 leukocytes (or 10\^3)) meeting one of the below:
• Complete remission (CR) defined as: \<5% blasts with ANC\> 1000 AND Plt \>100K
• CRh defined as \<5% blasts with ANC \> 500 AND Plt \>50K
• CRi defined as \<5% blasts with ANC\< 1000 OR Plt \< 100K
• Subject is willing and able to adhere to the study visit schedule and other protocol requirements.