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

NCT ID: NCT07211958

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 468 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-25
• Study Completion Date: 2031-01-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Revumenib + Intensive Chemotherapy

Participants will receive revumenib plus an intensive chemotherapy regimen.

Group Type: EXPERIMENTAL

Revumenib

Intervention Type: DRUG

Participants will receive revumenib orally.

Intensive Chemotherapy Regimen

Intervention Type: DRUG

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

Placebo + Intensive Chemotherapy

Participants will receive placebo plus an intensive chemotherapy regimen.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Intensive Chemotherapy Regimen

Intervention Type: DRUG

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

Interventions

Revumenib

Participants will receive revumenib orally.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Intensive Chemotherapy Regimen

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

Intervention Type: DRUG

Other Intervention Names

SNDX-5613

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Syndax Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Trial Site

Batumi, Adjara, Georgia

Site Status: RECRUITING

Clinical Trial Site

Tbilisi, , Georgia

Site Status: RECRUITING

Countries

Georgia

Central Contacts

Syndax Pharmaceuticals

Role: CONTACT

clinicaltrials@syndax.com

781-419-1400

Other Identifiers

2025-522279-27-00

Identifier Type: CTIS

Identifier Source: secondary_id

SNDX-5613-0710

Identifier Type: -

Identifier Source: org_study_id