Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation

Inclusion Criteria

• 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.
• Negative serum pregnancy test.
• Adequate liver, kidney, and cardiac function.

Key

Exclusion Criteria

• 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.
• Any concurrent malignancy requiring active therapy (except breast or prostate cancer stable on or responding to endocrine therapy).
• Inability to swallow oral medication.
• Pregnant or nursing females.
• Participant has known active or chronic hepatitis B or active hepatitis C (HCV) infection or human immunodeficiency virus (HIV)-positive with detectable viral load.

Note: Additional inclusion/exclusion criteria may apply, per protocol.