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

NCT07211958 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: SNDX-5613-07102025-522279-27-00
• Study Type: interventional
• Target: 468
• Locations: 6 countries
• Sites: 14

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Event Free Survival

  Up to 2 years

• Measurable Residual Disease Complete Remission Rate

  Up to 2 years

Secondary Outcomes (9)

• Overall Survival

  Up to 5 years

• Rate of Complete Remission

  Up to 2 years

• Rate of Composite Complete Remission

  Up to 2 years

• Overall Response Rate

  Up to 2 years

• Duration of Complete Remission

  Up to 2 years

Study Arms (2)

Revumenib + Intensive Chemotherapy

EXPERIMENTAL

Participants will receive revumenib plus an intensive chemotherapy regimen.

Drug: Revumenib; Drug: Intensive Chemotherapy Regimen

Placebo + Intensive Chemotherapy

PLACEBO COMPARATOR

Participants will receive placebo plus an intensive chemotherapy regimen.

Drug: Placebo; Drug: Intensive Chemotherapy Regimen

Interventions

Revumenib DRUG

Participants will receive revumenib orally.

Also known as: SNDX-5613

Revumenib + Intensive Chemotherapy

Placebo DRUG

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

Placebo + Intensive Chemotherapy

Intensive Chemotherapy Regimen DRUG

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

Placebo + Intensive Chemotherapy; Revumenib + Intensive Chemotherapy

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Syndax Pharmaceuticals: lead

Study Sites (14)

Clinical Trial Site

Batumi, Adjara, 6000, Georgia

RECRUITING

Clinical Trial Site

Tbilisi, 0112, Georgia

RECRUITING

Clinical Trial Site 1

Tbilisi, 0159, Georgia

RECRUITING

Clinical Trial Site 2

Tbilisi, 0159, Georgia

RECRUITING

Clinical Trial Site

Tbilisi, 0186, Georgia

RECRUITING

Clinical Trial Site

Düsseldorf, North Rhine-Westphalia, 40479, Germany

RECRUITING

Clinical Trial Site

Jerusalem, 91031, Israel

RECRUITING

Clinical Trial Site

Candiolo, 10060, Italy

RECRUITING

Clinical Trial Site

Palermo, 90146, Italy

RECRUITING

Clinical Trial Site

Goyang-si, 10408, South Korea

RECRUITING

Clinical Trial Site

Seoul, 03080, South Korea

RECRUITING

Clinical Trial Site

Seoul, 06591, South Korea

RECRUITING

Clinical Trial Site

London, W12 0HS, United Kingdom

RECRUITING

Clinical Trial Site

Sutton, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

revumenib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Syndax Pharmaceuticals

CONTACT

781-419-1400; clinicaltrials@syndax.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 8, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): January 1, 2031
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1); DE (1); IT (2); GB (2); GE (5); KR (3)