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
- Acute Myeloid Leukemias
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Syndax Pharmaceuticals
- Enrolment target
- 468
- Started
- 25 November 2025
- Main results due
- June 2029
- Study sites
- 149
- Registry updated
- 25 September 2026
Can you take part?
- Aged 12 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility 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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(149)
Clinical Trial Site
Goodyear, Arizona, United States
Recruiting
Clinical Trial Site
Duarte, California, United States
Recruiting
Clinical Trial Site
Indianapolis, Indiana, United States
Recruiting
Clinical Trial Site
Shreveport, Louisiana, United States
Recruiting
Clinical Trial Site
Providence, Rhode Island, United States
Recruiting
Clinical Trial Site
Houston, Texas, United States
Recruiting
Clinical Trial Site
Adrogué, Buenos Aires, Argentina
Recruiting
Clinical Trial Site
Córdoba, Córdoba Province, Argentina
Recruiting
Clinical Trial Site
Buenos Aires, Argentina
Recruiting
Clinical Trial Site
Salta, Argentina
Recruiting
Clinical Trial Site
Kingswood, New South Wales, Australia
Recruiting
Clinical Trial Site
Kogarah, New South Wales, Australia
Recruiting
Clinical Trial Site
Randwick, New South Wales, Australia
Recruiting
Clinical Trial Site
South Brisbane, Queensland, Australia
Recruiting
Clinical Trial Site
Melbourne, Victoria, Australia
Recruiting
Clinical Trial Site
Nedlands, Western Australia, Australia
Recruiting
Clinical Trial Site
Perth, Western Australia, Australia
Recruiting
Clinical Trial Site
Gosford, Australia
Recruiting
Clinical Trial Site
Wollongong, Australia
Recruiting
Clinical Trial Site
Klagenfurt, Kaerten, Austria
Recruiting
Clinical Trial Site
Sankt Pölten, Lower Austria, Austria
Recruiting
Clinical Trial Site
Graz, Styria, Austria
Recruiting
Clinical Trial Site
Leoben, Styria, Austria
Recruiting
Clinical Trial Site
Innsbruck, Tyrol, Austria
Recruiting
Clinical Trial Site
Linz, Austria
Recruiting
Clinical Trial Site
Vienna, Austria
Recruiting
Clinical Trial Site
Ghent, Belgium
Recruiting
Clinical Trial Site
São Paulo, Estado de Bahia, Brazil
Recruiting
Clinical Trial Site
Fortaleza, Paraná, Brazil
Recruiting
Clinical Trial Site
Barretos, São Paulo, Brazil
Recruiting
Clinical Trial Site
Jaú, Brazil
Recruiting
Clinical Trial Site
Porto Alegre, Brazil
Recruiting
Clinical Trial Site
London, Ontario, Canada
Recruiting
Clinical Trial Site
Montreal, Canada
Recruiting
Clinical Trial Site
Toronto, Canada
Recruiting
Clinical Trial Site
Nice, Alpes-Maritimes, France
Recruiting
Clinical Trial Site
Strasbourg, Bas-Rhin, France
Recruiting
Clinical Trial Site
Marseille, Bouches-Du-Rhône, France
Recruiting
Clinical Trial Site
Caen, Calvados, France
Recruiting
Clinical Trial Site
Rouen, Haute-Normandie, France
Recruiting
Clinical Trial Site
Limoges, Haute-Vienne, France
Recruiting
Clinical Trial Site
Angers, Loire-Atlantique, France
Recruiting
Clinical Trial Site
Lille, Nord, France
Recruiting
Clinical Trial Site
Pessac, Pas-de-Calais, France
Recruiting
Clinical Trial Site
Bayonne, France
Recruiting
Clinical Trial Site
Paris, France
Recruiting
Clinical Trial Site
Batumi, Adjara, Georgia
Recruiting
Clinical Trial Site
Tbilisi, Georgia
Recruiting
Clinical Trial Site 1
Tbilisi, Georgia
Recruiting
Clinical Trial Site 2
Tbilisi, Georgia
Recruiting
Clinical Trial Site
Tbilisi, Georgia
Recruiting
Clinical Trial Site
Heidelberg, Baden-Wurttemberg, Germany
Recruiting
Clinical Trial Site
Stuttgart, Baden-Wurttemberg, Germany
Recruiting
Clinical Trial Site
Tübingen, Baden-Wurttemberg, Germany
Recruiting
Clinical Trial Site
Düsseldorf, North Rhine-Westphalia, Germany
Recruiting
Clinical Trial Site
Herne, North Rhine-Westphalia, Germany
Recruiting
Clinical Trial Site
Minden, North Rhine-Westphalia, Germany
Recruiting
Clinical Trial Site
Chemnitz, Saxony, Germany
Recruiting
Clinical Trial Site
Jena, Thuringia, Germany
Recruiting
Clinical Trial Site
Hamburg, Germany
Recruiting
Showing 60 of 149 sites — filter to narrow it down. 149 of the 149 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07211958. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
Not the right study?
Answer three questions and see the studies recruiting near you, in plain language.
Find a study for me