A Randomized, Multicenter, Phase II Study of Maintenance Azacitidine and Venetoclax Versus an Allogeneic Stem Cell Transplant in Older Patients (65 Years and Older) With Acute Myeloid Leukemia Who Achieve an MRD Negative Complete Remission After Induction With Azacitidine and Venetoclax
Memorial Sloan Kettering Cancer Center
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
- Age range
- 65+ years
- Sex
- All
- Healthy volunteers
- No
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 star…