Venetoclax and HMA-Based Therapies for Older/Unfit Adults With Newly Diagnosed FLT3-Mutated AML

• Regimen 1 (azacitidine, venetoclax)

  Induction: Azacitidine days 1-7, Venetoclax days 1-28. Consolidation: Azacitidine days 1-7, Venetoclax days 1-28.

• Regimen 2 (azacitidine, venetoclax, gilteritinib)

  Induction: Azacitidine days 1-7, Venetoclax days 1-28, Gilteritinib days 1-28. Consolidation: Azacitidine days 1-5, Venetoclax days 1-7, Gilteritinib days 1-28.

• Regimen 3 (azacitidine, venetoclax, gilteritinib)

  Induction: Azacitidine days 1-7, Venetoclax days 1-28, Gilteritinib days 8-21. Consolidation: Azacitidine days 1-5, Venetoclax days 1-14, Gilteritinib days 8-21.

Primary

• Rate of measured residual disease negative complete remissionUp to 4 cycles (1 cycle = 28 days)

Secondary

• Rate of MRD negative CR/CR with incomplete count recovery/CR with partial hematologic recoveryUp to 4 cycles (1 cycle = 28 days)

• Rate of complete remissionUp to 10 years

• Rate of complete remission with incomplete count recoveryUp to 10 years

• Rate of complete remission with partial hematologic recoveryUp to 10 years

• Overall survivalUp to 10 years

• Event-free survivalUp to 10 years

• Incidence of adverse eventsUp to 10 years