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

NCT07211958 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 468

Last updated 2026-05-20

No results posted yet for this study

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

Interventions

DRUG

Revumenib

Participants will receive revumenib orally.

DRUG

Placebo

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

DRUG

Intensive Chemotherapy Regimen

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-25
Primary Completion
2029-06-30
Completion
2031-01-31
FDA Drug
Yes

Countries

  • Australia
  • Georgia
  • Germany
  • Israel
  • Italy
  • Romania
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07211958 on ClinicalTrials.gov