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RecruitingLast updated: 21 July 2026

REVEAL-ND NPM1: Testing whether adding a drug called revumenib to standard chemotherapy is safe and effective for people with newly diagnosed acute myeloid leukaemia with an NPM1 mutationA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Revumenib in Combination With Intensive Chemotherapy in Participants With Newly Diagnosed AML With an NPM1 Mutation

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People12+

Trial acronym

REVEAL-ND NPM1

Clinical summary

Summary

This study is looking at whether adding revumenib to standard chemotherapy can improve outcomes for people with acute myeloid leukaemia (AML) that has certain genetic changes. Researchers will also monitor participants closely to understand how safe the combination treatment is and what side effects it may cause.

You may be eligible if you:

  • have acute myeloid leukaemia (AML)
  • your AML is newly diagnosed and previously untreated
  • are able to receive intensive chemotherapy
  • have an NPM1 mutation

Eligible participants will be randomly assigned (by chance) to receive either:

  • Revumenib + intensive chemotherapy
  • Placebo + intensive chemotherapy

 

Conditions

This trial is treating people with newly diagnosed, untreated acute myeloid leukaemia with NPM1 mutation

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You are able to swallow medication by mouth.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

Syndax Pharmaceuticals

Scientific Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Revumenib in Combination With Intensive Chemotherapy in Participants With Newly Diagnosed AML With an NPM1 Mutation

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