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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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.

Where this trial is running

• Clinical Trial Site, Melbourne, Victoria, Australia
• Clinical Trial Site, Gosford, Australia
• Clinical Trial Site, Wollongong, Australia
• Clinical Trial Site, Linz, Austria
• Clinical Trial Site, Ghent, Belgium
• Clinical Trial Site, Jaú, Brazil
• Clinical Trial Site, Porto Alegre, Brazil
• Clinical Trial Site, Montreal, Canada
• Clinical Trial Site, Toronto, Canada
• Clinical Trial Site, Bayonne, France
• Clinical Trial Site, Bordeaux, France
• Clinical Trial Site, Batumi, Adjara, Georgia

+ 40 more sites.

Who to contact

Syndax Pharmaceuticals · 781-419-1400 · clinicaltrials@syndax.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07211958.