drugset / Trial / NCT07211958

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

NCT07211958

Phase 3 Recruiting 468 enrolled Syndax Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-11-25
Primary completion
2029-06
Completion
2031-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Revumenib Small molecule Oral
Background Cytarabine Small molecule Intravenous
Background Daunorubicin Small molecule Intravenous