The purpose of this study is to assess if adding revumenib to standard chemotherapy improves outcomes in participants with AML with certain genetic mutations compared to chemotherapy alone. The study will also assess the safety of adding revumenib to chemotherapy.
Participants must have newly diagnosed and previously untreated AML and be candidates for intensive chemotherapy.
Presence of an NPM1 mutation.
Eastern Cooperative Oncology Group performance status ≤2 (≤1 if >65 years old); Karnofsky or Lansky ≥40.
Have a life expectancy of ≥3 months as judged by the Investigator.
Diagnosis of active acute promyelocytic leukemia.
Active central nervous system disease.
Fridericia's corrected QT interval (QTcF) >450 milliseconds at screening, diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome.
Any gastrointestinal (GI) issue of the upper GI tract likely to affect oral drug absorption or ingestion.
Parallel
Revumenib
DrugParticipants will receive revumenib orally.
Placebo
DrugParticipants will receive placebo (non-active agent) orally.
Intensive Chemotherapy Regimen
DrugParticipants will receive an intensive chemotherapy regimen of cytarabine and daunorubicin by intravenous (IV) infusion.
Event Free Survival
Measurable Residual Disease Complete Remission Rate
Overall Survival
Rate of Complete Remission
Rate of Composite Complete Remission
Overall Response Rate
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