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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Clinical Trial Site
  Goodyear, Arizona, United States Recruiting
• Clinical Trial Site
  Duarte, California, United States Recruiting
• Clinical Trial Site
  Farmington, Connecticut, United States Recruiting
• Clinical Trial Site
  Tampa, Florida, United States Recruiting
• Clinical Trial Site
  Indianapolis, Indiana, United States Recruiting
• Clinical Trial Site
  Shreveport, Louisiana, United States Recruiting

+123 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Syndax Pharmaceuticals
• Email: clinicaltrials@syndax.com
• Phone: 781-419-1400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.