NCT07211958

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 468 (estimated)
• Sponsor: Syndax Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemias

Interventions

Type	Name	Description
DRUG	Revumenib	Participants will receive revumenib orally.
DRUG	Placebo	Participants will receive placebo (non-active agent) orally.
DRUG	Intensive Chemotherapy Regimen	Participants will receive an intensive chemotherapy regimen of cytarabine and daunorubicin by intravenous (IV) infusion.

Timeline

• Start date: 2025-11-25
• Primary completion: 2029-06-01
• Completion: 2031-01-01
• First posted: 2025-10-08
• Last updated: 2026-03-25

Locations

9 sites across 3 countries: Georgia, Israel, South Korea

Regulatory

• FDA-regulated drug study