Recruiting
Phase 3

Revumenib with Chemotherapy

Sponsor:

Syndax Pharmaceuticals

Code:

NCT07211958

Conditions

Acute Myeloid Leukemias

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

Revumenib

Placebo

Intensive Chemotherapy Regimen

Study Details

Brief 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.

Conditions

Acute Myeloid Leukemias

Study ID

NCT07211958

Start date

Nov 25, 2025

Status verified date

Aug, 2026

Completion date

Jan, 2031

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

468 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Revumenib + Intensive Chemotherapy

Participants will receive revumenib plus an intensive chemotherapy regimen.

placebo comparator: Placebo + Intensive Chemotherapy

Participants will receive placebo plus an intensive chemotherapy regimen.

Interventions

Revumenib

Participants will receive revumenib orally.

Placebo

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

Intensive Chemotherapy Regimen

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

Primary outcome measure

  • Event Free Survival [ Time Frame: Up to 2 years ]
  • Measurable Residual Disease Complete Remission Rate [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Syndax Pharmaceuticals

781-419-1400clinicaltrials@syndax.com

Locations

Clinical Trial Site

Recruiting

Goodyear, Arizona, United States, 85338

Clinical Trial Site

Recruiting

Duarte, California, United States, 91010

Clinical Trial Site

Recruiting

Shreveport, Louisiana, United States, 71103

Clinical Trial Site

Recruiting

Montreal, Canada, H1T 2M4

Clinical Trial Site

Recruiting

Toronto, Canada, M5G 2C1

More Information

Sponsor

Syndax Pharmaceuticals

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

  • SNDX-5613
  • Nucleophosmin 1
  • NPM1
  • Acute Myeloid Leukemias
  • AML
  • Revumenib
  • Newly diagnosed AML

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Syndax Pharmaceuticals on 2026-08-28.