Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Revumenib in Combination With Intensive Chemotherapy in Participants With Newly Diagnosed AML With an NPM1 Mutation
Syndax Pharmaceuticals
468 participants
Nov 25, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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.
Exclusion Criteria8
- 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.
Interventions
Participants will receive revumenib orally.
Participants will receive placebo (non-active agent) orally.
Participants will receive an intensive chemotherapy regimen of cytarabine and daunorubicin by intravenous (IV) infusion.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07211958