Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination with Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients with Untreated NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia

Trial status: Authorised Nonintensive Therapy Study - CR rate per the ELN 2022 criteria per Investigator assessment - Percentage of patients achieving centrally defined BM MRD negativity - Rates of CR+CRh per ELN 2022 per Investigator assessment, Intensive Therapy Study (7+3) - Percentage of patients achieving CR per ELN 2022 criteria with centrally defined BM MRD negativity (CRMRD-) - Overall survival (OS) Nonintensive Therapy Study - Overall survival (OS) Intensive Therapy Study (7+3) - EFS, defined as the time from randomization to treatment failurea, hematologic relapse following CR, or death from any cause, whichever comes first

Nonintensive Therapy Study - CR rate per the ELN 2022 criteria per Investigator assessment - Percentage of patients achieving centrally defined BM MRD negativity - Rates of CR+CRh per ELN 2022 per Investigator assessment, Intensive Therapy Study (7+3) - Percentage of patients achieving CR per ELN 2022 criteria with centrally defined BM MRD negativity (CRMRD-) - Overall survival (OS)

Age group: 65+ years, 18-64 years Gender: Female, Male Target enrollment: 719 participants