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ACTIVE NOT RECRUITINGPhase1

A Study of Revumenib in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias

Sponsor: Syndax Pharmaceuticals

NCT ID: NCT06226571

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), Chemotherapy Regimen (drug), HiDAC (drug)
How long the study runs
Study runs about 33 months (dates as stated)
About the drug or intervention
Revumenib — drug: Participants will receive revumenib orally during Induction, Consolidation, and Maintenance until meeting criteria for discontinuation. · Chemotherapy Regimen — drug: Induction: Participants will receive an intravenous (IV), 2-drug combination of cytarabine and either daunorubicin or idarubicin. · HiDAC — drug: Consolidation: Participants will receive HiDAC IV.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 75 Years
Who
All
Number of participants
96
Started
2024-05-21
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for acute myeloid leukemias
  • • Phase1 - 96 participants
  • • The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of revumenib in combination with intensive chemotherapy in participants with newly diagnosed acute myeloid leukemia (AML) harboring alterations in KMT2A, NPM1, or NUP98 genes

Who can take part?

  • • Ages 18 Years to 75 Years
  • • Diagnosed with acute myeloid leukemias

Where?

  • • London - Hammersmith Hospital
  • • Sutton - The Royal Marsden NHS

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

About This Trial

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of revumenib in combination with intensive chemotherapy in participants with newly diagnosed acute myeloid leukemia (AML) harboring alterations in KMT2A, NPM1, or NUP98 genes.

More detail

The Dose Escalation portion of this study will identify the maximum tolerated dose, or if different, the recommended Phase 2 dose of revumenib to be used in combination with intensive chemotherapy and in maintenance monotherapy following intensive chemotherapy in participants with newly diagnosed AML harboring alterations in KMT2A, NPM1, or NUP98 genes. In the Dose Expansion portion of the study, safety and preliminary efficacy of revumenib may be explored in expansion cohorts at tolerated dose levels. In both Dose Escalation and Dose Expansion, the treatment period will consist of an induction phase (up to 2 cycles), a consolidation phase (up to 4 cycles and could include hematopoietic stem cell transplant for participants who are transplant eligible and have an available donor), and a maintenance monotherapy phase with revumenib. The cycle duration will be 28 days.

Acute Myeloid Leukemias

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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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: 18 Years - 75 Years
  • Who can join: All genders

What the study is looking for

  • ✓Established, pathologically confirmed diagnosis of AML by World Health Organization 2022 criteria.
  • ✓Newly diagnosed and previously untreated AML and eligible to receive intensive drug treatment.
  • ✓KMT2Ar, NPM1m, or NUP98r mutations identified by local laboratory prior to the first dose of revumenib.
  • ✓activity scale performance status ≤2 and ≤1 if \>65 years old.
  • ✓Adequate liver, kidney, and heart function.

Who cannot take part

  • ✗Diagnosis of acute promyelocytic leukemia.
  • ✗Clinically active central nervous system leukemia (blasts detected in cerebrospinal fluid, radiographic or clinical...
  • ✗Fridericia's corrected QT interval (QTcF) \>450 milliseconds (average of triplicate), diagnosis or suspicion of Long...
  • ✗Any gastrointestinal issue of the upper gastrointestinal tract that might affect oral drug absorption or ingestion.
  • ✗Cirrhosis with a Child-Pugh score of B or C.
See the full criteria
Inclusion Criteria: * Established, pathologically confirmed diagnosis of AML by World Health Organization 2022 criteria. * Newly diagnosed and previously untreated AML and eligible to receive intensive chemotherapy. * KMT2Ar, NPM1m, or NUP98r mutations identified by local laboratory prior to the first dose of revumenib. * Eastern Cooperative Oncology Group performance status ≤2 and ≤1 if \>65 years old. * Adequate liver, kidney, and cardiac function. Exclusion Criteria: * Diagnosis of acute promyelocytic leukemia. * Clinically active central nervous system leukemia (blasts detected in cerebrospinal fluid, radiographic or clinical signs and symptoms). * Fridericia's corrected QT interval (QTcF) \>450 milliseconds (average of triplicate), diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome. * Any gastrointestinal issue of the upper gastrointestinal tract that might affect oral drug absorption or ingestion. * Cirrhosis with a Child-Pugh score of B or C. * Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack. * Hepatitis B, Hepatitis C, or HIV-positive with detectable viral load. * Documented active, uncontrolled infection. * Uncontrolled disseminated intravascular coagulation. * Lactating/breast feeding or pregnant. * Use of prohibited concomitant chemotherapy, radiation therapy, or immunotherapy. * Use of strong CYP3A4 inducers or inhibitors (except for Itraconazole, Ketoconazole, Posaconazole, or Voriconazole).

Where Is This Study? (2 UK sites)

Hammersmith Hospital

London W12 0HS, United Kingdom

The Royal Marsden NHS

Sutton SM2 5PT, United Kingdom

Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416
Data sourced from ClinicalTrials.gov · Last verified: 2026-09