Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified July 2026 by Syndax Pharmaceuticals
Sponsor
Syndax Pharmaceuticals
Information Provided by (Responsible Party)
Syndax Pharmaceuticals
Clinicaltrials.gov Identifier
NCT07211958
Other Study ID Numbers:
SNDX-5613-0710
First Submitted
September 29, 2025
First Posted
October 7, 2025
Last Update Posted
August 27, 2026
Last Verified
July 2026

ClinicalTrials.gov processed this data on August 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Acute Myeloid Leukemias
Drug: RevumenibDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment468 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA 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
Study Start DateNovember 24, 2025
Actual Primary Completion Date2yrs 8mos from now
Actual Study Completion Date4yrs 3mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Revumenib + Intensive Chemotherapy
Participants will receive revumenib plus an intensive chemotherapy regimen.
Drug: Revumenib
Participants will receive revumenib orally.
Placebo + Intensive Chemotherapy
Participants will receive placebo plus an intensive chemotherapy regimen.
Drug: Placebo
Participants will receive placebo (non-active agent) orally.

Outcome Measures

Primary Outcome Measures
  1. Event Free Survival
  2. Measurable Residual Disease Complete Remission Rate
Secondary Outcome Measures
  1. Overall Survival
  2. Rate of Complete Remission
  3. Rate of Composite Complete Remission
  4. Overall Response Rate
  5. Duration of Complete Remission
  6. Duration of Composite Complete Remission
  7. Duration of Response
  8. Number of Participants with a Treatment-emergent Adverse Event
  9. Change from Baseline in Patient-reported Fatigue Questionnaire Scores

Eligibility Criteria

Ages Eligible for Study(Child, Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsSyndax Pharmaceuticals
Locations
Clinical Trial Site | Goodyear Arizona, United States, 85338Clinical Trial Site | Duarte California, United States, 91010Clinical Trial Site | Shreveport Louisiana, United States, 71103Clinical Trial Site | South Brisbane Queensland, Australia, 4101Clinical Trial Site | Melbourne Victoria, Australia, 3004Clinical Trial Site | Nedlands Western Australia, Australia, 6009Clinical Trial Site | Perth Western Australia, Australia, 6000Clinical Trial Site | Gosford , Australia, 2250Clinical Trial Site | Wollongong , Australia, 2500Clinical Trial Site | Klagenfurt Kaerten, Austria, 9020Clinical Trial Site | Sankt Pölten Lower Austria, Austria, 3100Clinical Trial Site | Graz Styria, Austria, 8036Clinical Trial Site | Leoben Styria, Austria, 8700Clinical Trial Site | Linz , Austria, 4030Clinical Trial Site | Ghent , Belgium, 9000Clinical Trial Site | Fortaleza Paraná, Brazil, 60430-372Clinical Trial Site | Barretos São Paulo, Brazil, 14784-400Clinical Trial Site | Jaú , Brazil, 17210-080Clinical Trial Site | Porto Alegre , Brazil, 90610-910Clinical Trial Site | Montreal , Canada, H1T 2M4Clinical Trial Site | Toronto , Canada, M5G 2C1Clinical Trial Site | Nice Alpes-Maritimes, France, 06200Clinical Trial Site | Strasbourg Bas-Rhin, France, 67098Clinical Trial Site | Angers Loire-Atlantique, France, 44093Clinical Trial Site | Pessac Pas-de-Calais, France, 33608Clinical Trial Site | Bayonne , France, 64100Clinical Trial Site | Batumi Adjara, Georgia, 6000Clinical Trial Site | Tbilisi , Georgia, 0112Clinical Trial Site 1 | Tbilisi , Georgia, 0159Clinical Trial Site 2 | Tbilisi , Georgia, 0159Clinical Trial Site | Tbilisi , Georgia, 0186Clinical Trial Site | Heidelberg Baden-Wurttemberg, Germany, 69120Clinical Trial Site | Tübingen Baden-Wurttemberg, Germany, 72076Clinical Trial Site | Düsseldorf North Rhine-Westphalia, Germany, 40479Clinical Trial Site | Herne North Rhine-Westphalia, Germany, 44625Clinical Trial Site | Jena Thuringia, Germany, 07747Clinical Trial Site | Hamburg , Germany, 20251Clinical Trial Site | Patras North Aegean, Greece, 26504Clinical Trial Site | Győr Gyor-Moson-Sopron Varmegye, Hungary, H-9024Clinical Trial Site | Budapest , Hungary, 1088Clinical Trial Site | Petah Tikva Central District, Israel, 4941492Clinical Trial Site | Jerusalem Jerusalem, Israel, 9124001Clinical Trial Site | Tel Aviv Tel Aviv, Israel, 6423906Clinical Trial Site | Haifa , Israel, 3109601Clinical Trial Site | Jerusalem , Israel, 91031Clinical Trial Site | Jerusalem , Israel, 91120Clinical Trial Site | Monza Monza E Brianza, Italy, 20900Clinical Trial Site | Pesaro Pesaro E Urbino, Italy, 61122Clinical Trial Site | Alessandria , Italy, 15121Clinical Trial Site | Bergamo , Italy, 24127Clinical Trial Site | Bologna , Italy, 40138Clinical Trial Site | Brescia , Italy, 25123Clinical Trial Site | Candiolo , Italy, 10060Clinical Trial Site | Florence , Italy, 50134Clinical Trial Site | Meldola , Italy, 47014Clinical Trial Site | Milan , Italy, 20132Clinical Trial Site | Milan , Italy, 20141Clinical Trial Site | Milan , Italy, 20162Clinical Trial Site | Palermo , Italy, 90146Clinical Trial Site | Pavia , Italy, 27100Clinical Trial Site | Perugia , Italy, 06132Clinical Trial Site | Pisa , Italy, 56126Clinical Trial Site | Reggio Emilia , Italy, 42123Clinical Trial Site | Rimini , Italy, 47923Clinical Trial Site | Roma , Italy, 00168Clinical Trial Site | Torino , Italy, 10128Clinical Trial Site | Udine , Italy, 33100Clinical Trial Site | Vilnius , Lithuania, 08661Clinical Trial Site | Johor Bahru Johor, Malaysia, 80000Clinical Trial Site | Petaling Jaya , Malaysia, 46050Clinical Trial Site | Subang Jaya , Malaysia, 46150Clinical Trial Site | Târgu Mureş Mureș County, Romania, 540136Clinical Trial Site | Bucharest , Romania, 020125Clinical Trial Site | Bucharest , Romania, 030171Clinical Trial Site | Cluj-Napoca , Romania, 400015Clinical Trial Site | Iași , Romania, 700483Clinical Trial Site | Busan Busan Gwang'yeogsi [Pusan-Kwangyokshi], South Korea, 49201Clinical Trial Site | Daegu Daegu Gwang'yeogsi [Taegu-Kwangyokshi], South Korea, 41944Clinical Trial Site | Daegu Daegu Gwang'yeogsi [Taegu-Kwangyokshi], South Korea, 42472Clinical Trial Site | Busan , South Korea, 48108Clinical Trial Site | Goyang-si , South Korea, 10408Clinical Trial Site | Seoul , South Korea, 03080Clinical Trial Site | Seoul , South Korea, 06591Clinical Trial Site | Badalona Barcelona, Spain, 08916Clinical Trial Site | L'Hospitalet de Llobregat Barcelona, Spain, 08908Clinical Trial Site | Las Palmas de Gran Canaria Canary Islands, Spain, 35010Clinical Trial Site | Oviedo Principality of Asturias, Spain, 33011Clinical Trial Site | Alicante , Spain, 03010Clinical Trial Site | Barcelona , Spain, 08036Clinical Trial Site | Burgos , Spain, 09006Clinical Trial Site | Cáceres , Spain, 10003Clinical Trial Site | Granada , Spain, 18014Clinical Trial Site | Madrid , Spain, 28007Clinical Trial Site | Madrid , Spain, 28009Clinical Trial Site | Madrid , Spain, 28033Clinical Trial Site | Madrid , Spain, 28034Clinical Trial Site | Málaga , Spain, 29010Clinical Trial Site | Palma , Spain, 07120Clinical Trial Site | Pamplona , Spain, 31008Clinical Trial Site | Salamanca , Spain, 37007Clinical Trial Site | Seville , Spain, 41013Clinical Trial Site | Valencia , Spain, 46026Clinical Trial Site | Oxford Oxfordshire, United Kingdom, OX3 7LJClinical Trial Site | Aberdeen , United Kingdom, AB25 2ZNClinical Trial Site | Derby , United Kingdom, DE22 3NEClinical Trial Site | Lincoln , United Kingdom, LN2 5QYClinical Trial Site | London , United Kingdom, W12 0HSClinical Trial Site | Southampton , United Kingdom, SO16 6YDClinical Trial Site | Sutton , United Kingdom, SM2 5PT