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Clinical Trials in the UK / NCT06226571
Active, not recruiting Phase 1

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

NCT06226571 · tracked via the Priya Life Science UK tracker
Sponsor
Syndax Pharmaceuticals
Phase
Phase 1
Started
2024-05-21
Last updated
2026-09-16

Condition(s) studied

Acute Myeloid Leukemias

Investigational drug(s) / intervention(s)

RevumenibChemotherapy RegimenHiDAC

Revumenib: Participants will receive revumenib orally during Induction, Consolidation, and Maintenance until meeting criteria for discontinuation.

Chemotherapy Regimen: Induction: Participants will receive an intravenous (IV), 2-drug combination of cytarabine and either daunorubicin or idarubicin.

HiDAC: Consolidation: Participants will receive HiDAC IV.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (48)

FacilityCityRegionStatus
City of Hope Goodyear Arizona
UCLA Medical Hematology Burbank California
City of Hope Medical Center Duarte California
AdventHealth Blood & Marrow Transplant Center Orlando Florida
Tampa General Hospital Tampa Florida
Emory Winship Cancer Institute Atlanta Georgia
University of Illinois Chicago Illinois
University of Chicago Chicago Illinois
University of Louisville Health Brown Cancer Center Louisville Kentucky
Norton Cancer Institute, St. Matthews Campus Louisville Kentucky
Beth Israel Deaconess Medical Center Boston Massachusetts
University of Michigan Ann Arbor Michigan
Allina Health Cancer Institute Minneapolis Minnesota
Washington University School of Medicine St Louis Missouri
Institution name: Northwell Health-Brany Lake Success New York
Memorial Sloan Kettering Cancer Center New York New York
University of Rochester Medical Center Rochester New York
SUNY Upstate Medical University Syracuse New York
East Carolina University Greenville North Carolina
Atrium Health Wake Forest Baptist Medical Center Winston-Salem North Carolina
Cleveland Clinic Foundation Cleveland Ohio
Oregon Health and Science University- Center for Hematologic Malignancies Portland Oregon
UPMC Hillman Cancer Center Pittsburgh Pennsylvania
MUSC Hollings Cancer Center (HCC) Charleston South Carolina
Baylor University Medical Center Dallas Texas
The University of Texas, MD Anderson Cancer Center Houston Texas
LDS Hospital - Intermountain Healthcare Salt Lake City Utah
West Virginia University Morgantown West Virginia
Northern Hospital, Victoria Epping Victoria
Royal Perth Hospital Perth Western Australia
Royal Adelaide Hospital Adelaide Australia
The Alfred Hospital, Victoria Melbourne Australia
Sir Charles Gairdner Hospital Nedlands Australia
University of Alberta Hospital Edmonton Alberta
Gordon and Leslie Diamond Health Care Center Vancouver British Columbia
The Sir Mortimer B. Davis Jewish General Hospital Montreal Quebec
University Medical Center Utrecht Utrecht Netherlands
Hospital Universitario Marques de Valdecilla Santander Cantabria
Hospital Clinic de Barcelona Barcelona Spain
Hospital San Pedro de Alcantara Cáceres Spain

+ 8 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06226571 on ClinicalTrials.gov ↗ ← All trials in the UK