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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
given daily for 7 days starting on Day 1 of each Cycle
orally daily for 28 days
After the conditioning treatment, the HSCT procedure is part of standard care on Day 0.
1-year Relapse free survival (RFS)
Relapse free survival (RFS)- will be defined with patients being alive and without any evidence of disease. i.e. no morphologic relapse and no emergence of minimal residual disease. In the event of emergence of MRD without a morphologic relapse, this will be defined as relapse only if documented on 2 separate time points. For patients alive and in remission at the data cut-off, RFS will be censored at the last assessment date.
Time frame: 1 year
Overall survival (OS)
will be defined with patients being alive and non-relapse mortality (NRM) will be defined as death in the absence of disease recurrence.
Time frame: 3 years
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