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 [REVEAL-ND NPM1] (NCT07211958)

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.

Trial phase

Phase 3

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

A/Prof Shaun Fleming

Key inclusion data

INCLUSION: 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. 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. Participant has known active or chronic hepatitis B or active hepatitis C (HCV) infection or human immunodeficiency virus (HIV)-positive with detectable viral load.