Status:
RECRUITING
Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation
Lead Sponsor:
Syndax Pharmaceuticals
Conditions:
Acute Myeloid Leukemias
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
November 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2031
Estimated Enrollment :
468 Patients enrolled
Trial Details
Trial ID
NCT07211958
Start Date
November 25 2025
End Date
January 1 2031
Last Update
December 8 2025
Active Locations (2)
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1
Clinical Trial Site
Batumi, Adjara, Georgia, 6000
2
Clinical Trial Site
Tbilisi, Georgia, 0159