RecruitingPhase 3NCT07211958

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


Sponsor

Syndax Pharmaceuticals

Enrollment

468 participants

Start Date

Nov 25, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a drug called Revumenib to standard intensive chemotherapy improves outcomes for people newly diagnosed with acute myeloid leukemia (AML) that carries a specific genetic mutation called NPM1 — a common change that affects how certain blood cells grow. **You may be eligible if...** - You are newly diagnosed with AML (not previously treated) and are a candidate for intensive chemotherapy - Your leukemia has an NPM1 gene mutation - You are in good general health (ECOG ≤ 2, or ≤ 1 if over 65) - Your liver, kidneys, and heart function are adequate - You have a life expectancy of at least 3 months **You may NOT be eligible if...** - You have acute promyelocytic leukemia (a different subtype) - You have active central nervous system disease - Your heart's QT interval is prolonged on ECG - You have a stomach or gut condition that prevents you from absorbing oral medication Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGRevumenib

Participants will receive revumenib orally.

DRUGPlacebo

Participants will receive placebo (non-active agent) orally.

DRUGIntensive Chemotherapy Regimen

Participants will receive an intensive chemotherapy regimen of cytarabine and daunorubicin by intravenous (IV) infusion.


Locations(9)

Clinical Trial Site

Batumi, Adjara, Georgia

Clinical Trial Site

Tbilisi, Georgia

Clinical Trial Site 1

Tbilisi, Georgia

Clinical Trial Site 2

Tbilisi, Georgia

Clinical Trial Site

Tbilisi, Georgia

Clinical Trial Site

Jerusalem, Israel

Clinical Trial Site

Goyang-si, South Korea

Clinical Trial Site

Seoul, South Korea

Clinical Trial Site

Seoul, South Korea

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07211958


Related Trials