A Phase III, randomized, double-blind, placebo-controlled study of revumenib in combination with intensive chemotherapy in participants with newly diagnosed AML with an NPM1 mutation (REVEAL-ND NPM1)
Newly diagnosed acute myeloid leukemia (AML) with an NPM1 mutation
Experimental Arm: Revumenib + Intensive Chemotherapy (IC). Participants will receive revumenib orally plus an IC regimen of cytarabine and danorubicin by intravenous (IV) infusion. Placebo Comparator: Placebo + IC. Participants will receive placebo (non-active agent) orally plus and IC regimen of cytarabine and danorubicin by IV. Please note that the dose range, frequency and randomisation process are considered CCI and cannot be disclosed.
1. Participants must have newly diagnosed and previously untreated AML and be candidates for intensive chemotherapy 2. Presence of an NPM1 mutation 3. Eastern Cooperative Oncology Group performance status ≤2 (≤1 if >65 years old); Karnofsky or Lansky ≥40 4. Have a life expectancy of ≥3 months as judged by the Investigator 5. Negative serum pregnancy test 6. Adequate liver, kidney, and cardiac function
1. Diagnosis of active acute promyelocytic leukemia 2. Active central nervous system disease 3. Fridericia's corrected QT interval (QTcF) >450 milliseconds at screening, diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome 4. Any gastrointestinal (GI) issue of the upper GI tract likely to affect oral drug absorption or ingestion 5. Any concurrent malignancy requiring active therapy (except breast or prostate cancer stable on or responding to endocrine therapy) 6. Inability to swallow oral medication 7. Pregnant or nursing females 8. Participant has known active or chronic hepatitis B or active hepatitis C (HCV) infection or human immunodeficiency virus (HIV)-positive with detectable viral load