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

Syndax Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Acute Myeloid Leukemias

Treatments: Drug: Revumenib; Drug: Intensive Chemotherapy Regimen; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07211958

2025-522279-27-00 (EU Trial (CTIS) Number)

SNDX-5613-0710

Details and patient eligibility

About

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.

Enrollment: 468 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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468 participants in 2 patient groups, including a placebo group

Revumenib + Intensive Chemotherapy

Experimental group

Description:

Participants will receive revumenib plus an intensive chemotherapy regimen.

Treatment:

Drug: Intensive Chemotherapy Regimen

Drug: Revumenib

Placebo + Intensive Chemotherapy

Placebo Comparator group

Description:

Participants will receive placebo plus an intensive chemotherapy regimen.

Treatment:

Drug: Placebo

Drug: Intensive Chemotherapy Regimen