A Randomized Phase II Study of Venetoclax and HMA-based Therapies for the Treatment of Older and Unfit Adults with Newly Diagnosed FLT3-mutated Acute Myeloid Leukemia (AML): A MyeloMATCH Treatment Trial
Objective
Primary Objectives: To compare the achievement rate of MRDneg CR of either triplet regimen to azacitidine and venetoclax alone within 4 cycles of therapy.
Secondary Objectives: To compare the achievement rate of MRDneg CR/CRi/CRh of either triplet regimen to azacitidine and venetoclax alone within 4 cycles of therapy. To determine the safety and tolerability of the combination of gilteritinib, azaciditine, and venetoclax, if both of the triplet regimens show superiority to the azacitidine plus venetoclax regimen. To determine the optimal sequence and duration of gilteritinib, when added to azacitidine and venetoclax if both of the triplet regimens show superiority to the azacitidine plus venetoclax regimen. To estimate the rates of complete remission (CR), complete remission with incomplete count recovery (CRi), and complete remission with partial hematologic recovery (CRh), MLFS, event-free survival (EFS), and overall survival (OS) of the combination of gilteritinib, azaciditine, and venetoclax versus azacitidine and venetoclax alone.
