Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML

This protocol encompasses two phase 3, randomized, double-blind, placebo-controlled clinical studies to assess the efficacy, safety, and tolerability of ziftomenib in combination with: (a) the standard of care (SOC) nonintensive regimen (venetoclax \[ven\]+azacitidine \[aza\]) in untreated adults with nucleophosmin 1 mutated (NPM1-m) acute myeloid leukemia (AML); or (b) the SOC intensive regimen (cytarabine+daunorubicin induction, referred to here as 7+3, and cytarabine consolidation) in untreated adults with NPM1-m or lysine\[K\]-specific methyltransferase 2A rearranged (KMT2A-r) AML, as well as a maintenance phase. Nonintensive Therapy Study (Ven+Aza) Eligible NPM1-m patients will be enrolled and randomized to receive: * Arm A: Ziftomenib in combination with ven+aza or * Arm B: Placebo in combination with ven+aza. Patients will be randomized to treatment arms in a double-blind manner. Intensive Therapy Study (Cytarabine+Daunorubicin) Eligible NPM1-m or KMT2A-r patients will be enrolled and randomized to 1 of the following treatment arms: * Arm A: Ziftomenib+7+3 (induction), ziftomenib+cytarabine (consolidation), ziftomenib (maintenance) or * Arm B: Ziftomenib+7+3 (induction), ziftomenib+cytarabine (consolidation), placebo (maintenance) or * Arm C: Placebo+7+3 (induction), placebo+cytarabine (consolidation), placebo (maintenance). Patients will be randomized to treatment arms in a double-blind manner.