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Looking for participantsPhase3

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

Sponsor: Syndax Pharmaceuticals

NCT ID: NCT07211958

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Revumenib (drug), Placebo (drug), Intensive Chemotherapy Regimen (drug)
How long the study runs
Study runs about 62 months (dates as stated)
About the drug or intervention
Revumenib — drug: Participants will receive revumenib orally. · Placebo — drug: Participants will receive placebo (non-active agent) orally. · Intensive Chemotherapy Regimen — drug: Participants will receive an intensive chemotherapy regimen of cytarabine and daunorubicin by intravenous (IV) infusion.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
12 Years and over
Who
All
Number of participants
468
Started
2025-11-25
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for acute myeloid leukemias
  • • Phase3 - 468 participants
  • • 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

Who can take part?

  • • Ages 12 Years and over
  • • Diagnosed with acute myeloid leukemias

Where?

  • • Oxford - Clinical Trial Site
  • • Aberdeen - Clinical Trial Site
  • • Derby - Clinical Trial Site
  • • Lincoln - Clinical Trial Site
  • • +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Acute Myeloid Leukemias

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 12 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ newly diagnosed and previously untreated AML and be candidates for intensive chemotherapy

What the study is looking for

  • ✓Participants must have newly diagnosed and previously untreated AML and be candidates for intensive drug treatment.
  • ✓Presence of an NPM1 mutation.
  • ✓activity scale performance status ≤2 (≤1 if \>65 years old); Karnofsky or Lansky ≥40.
  • ✓Have a expected to live at least 3 $2 as judged by the Investigator.
  • ✓Negative serum pregnancy test.

Who cannot take part

  • ✗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...
  • ✗Any gastrointestinal (GI) issue of the upper GI tract likely to affect oral drug absorption or ingestion.
  • ✗Any concurrent cancer requiring active therapy (except breast or prostate cancer stable on or responding to...
See the full 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.

Where Is This Study? (7 UK sites)

Clinical Trial Site

Oxford OX3 7LJ, United Kingdom

Recruiting

Clinical Trial Site

Aberdeen AB25 2ZN, United Kingdom

Recruiting

Clinical Trial Site

Derby DE22 3NE, United Kingdom

Recruiting

Clinical Trial Site

Lincoln LN2 5QY, United Kingdom

Recruiting

Clinical Trial Site

London W12 0HS, United Kingdom

Recruiting

Clinical Trial Site

Southampton SO16 6YD, United Kingdom

Recruiting

Clinical Trial Site

Sutton SM2 5PT, United Kingdom

Recruiting

How to Get in Touch

Syndax Pharmaceuticals

Sponsor contact

CONTACT

781-419-1400 clinicaltrials@syndax.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09