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Revumenib plus intensive chemotherapy for newly diagnosed NPM1‑mutated acute myeloid leukemia

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

Phase 3 Interventional Syndax Pharmaceuticals · NCT07211958

This trial tests whether adding revumenib to standard intensive chemotherapy helps people newly diagnosed with NPM1‑mutated AML get better responses and live longer than chemotherapy alone.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment468 (estimated)
Ages12 Years and up
SexAll
SponsorSyndax Pharmaceuticals Industry-sponsored
Drugs / interventionschemotherapy
Locations14 sites (Batumi, Adjara and 13 other locations)
Trial IDNCT07211958 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional study enrolls people with newly diagnosed, previously untreated AML who have an NPM1 mutation and are candidates for intensive chemotherapy. Participants receive a standard intensive chemotherapy regimen and are also given either revumenib or a placebo in addition to chemotherapy to compare outcomes. The study tracks remission rates, survival outcomes, and side effects to determine if the combination provides clinical benefit and is safe. Safety monitoring includes assessments of organ function, cardiac rhythm (QTc), and ability to tolerate oral medication.

Who should consider this trial

Good fit: Ideal candidates are people with newly diagnosed, previously untreated AML who have an NPM1 mutation, are eligible for intensive chemotherapy, have adequate liver/kidney/heart function, meet the ECOG/Karnofsky performance criteria, and can take oral medication.

Not a fit: Patients with acute promyelocytic leukemia, active CNS disease, significant QT prolongation or related family history, upper GI problems that prevent oral drug absorption, concurrent active cancer requiring therapy, inability to swallow pills, or pregnancy are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, adding revumenib could raise remission rates, extend survival, and reduce relapse risk for people with NPM1‑mutated AML.

How similar studies have performed: Early-phase studies of revumenib and other menin inhibitors have shown promising responses in NPM1‑mutant AML, but combining revumenib with intensive chemotherapy in newly diagnosed patients is a newer approach now being tested in this Phase 3 trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Batumi, Adjara and 13 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Myeloid LeukemiasSNDX-5613Nucleophosmin 1NPM1AMLRevumenibNewly diagnosed AML
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.