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Clinical Trials in the UK / NCT06852222
Recruiting Phase 3

A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

NCT06852222 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2025-06-04
Last updated
2026-08-28

Condition(s) studied

Leukemia, Myeloid, Acute

Investigational drug(s) / intervention(s)

BleximenibVenetoclax (VEN)Azacitidine (AZA)Placebo

Bleximenib: Bleximenib will be administered orally.

Venetoclax (VEN): VEN will be administered orally.

Azacitidine (AZA): AZA will be administered intravenously or subcutaneously.

Placebo: Placebo will be administered orally.

Study summary

The purpose of this study is to assess how bleximenib and Venetoclax (VEN)+ Azacitidine (AZA) works as compared to placebo and VEN+AZA alone for the treatment of participants with newly diagnosed Acute Myeloid Leukemia (AML) with a mutation in the NPM1 or KMT2A gene.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion criteria: * Be 18 years of age or older at the time of informed consent * Previously untreated lysine N-methyltransferase 2A gene rearranged (KMT2Ar) or nucleophosmin 1 gene mutated (NPM1m) acute myeloid leukemia (AML) with greater than or equal to (\> or =) 10% bone marrow blasts per 2022 international Consensus Classification criteria * Ineligible for intensive chemotherapy based on the following criteria: a) \>= 75 years of age and ineligible per physician's discretion, with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, b) \>=18 to \<75 years of age with \>= 1 of the following comorbidities: i) ECOG performance status of 2, ii) Severe cardiac disorder, iii) Severe pulmonary disorder, iv) Renal impairment, v) Moderate hepatic impairment vi) Comorbidity that, in the investigator's opinion, makes the participant unsuitable for intensive chemotherapy, which must be documented before enrollment as defined in the protocol. Ineligibility for intensive chemotherapy should be explicitly approved by a multidisciplinary team in countries in which this process is standard of care * Participants must have adequate hepatic and renal function * A female participant must agree not to be pregnant, breast-feed, plan to become pregnant and use protocol-specified contraception while enrolled in this study and for 6 months after the last dose of study treatment * A male participant must agree to use protocol-specified contraception while enrolled in this study for at least 90 days after the last dose of study treatment * Must sign an informed consent form indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study Exclusion criteria: * Diagnosis of acute promyelocytic leukemia (APL) * Known active leukemic involvement of the central nervous system (CNS) * Recipient of solid organ transplant * Any cardiac disorders such as heart attack, uncontrolled/unstable chest pain, congestive heart failure, uncontrolled or symptomatic irregular heartbeat, blockage of a blood vessel to brain, or transient ischemic (decreased oxygen in tissue) attack within 6 months of randomization * Active infectious hepatitis * Live, attenuated vaccine within 4 weeks of randomization * Known allergies, hypersensitivity, or intolerance of bleximenib, azacitidine, or venetoclax excipients

Primary outcome measure(s)

Trial sites (262)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Recruiting
Cancer Treatment Center of America Phoenix Goodyear Arizona Recruiting
The University of Arizona Cancer Center Tucson Arizona Recruiting
University of Arkansas at Little Rock Little Rock Arkansas Recruiting
City of Hope Duarte California Recruiting
Rocky Mountain Cancer Centers Aurora Colorado Recruiting
Medical Oncology Hematology Consultants, PA Newark Delaware Recruiting
Florida Cancer Specialists & Research Institute Fort Myers Florida Recruiting
Jupiter Research Jupiter Florida Recruiting
AdventHealth Medical Group Blood & Marrow Transplant at Orlando Orlando Florida Recruiting
Orlando Health Cancer Institute Orlando Florida Recruiting
Memorial Cancer Institute Pembroke Pines Florida Recruiting
Moffit Cancer center Tampa Florida Recruiting
Cleveland Clinic Florida Weston Florida Recruiting
University of Chicago Medicine Chicago Illinois Recruiting
Illinois Cancer Specialists Niles Illinois Recruiting
University of Kentucky Markey Cancer Center Lexington Kentucky Recruiting
UofL Health Brown Cancer Center Louisville Kentucky Recruiting
Norton Cancer Institute Louisville Kentucky Recruiting
Mary Bird Perkins Cancer Center Baton Rouge Louisiana Recruiting
Center for Cancer and Blood Disorders Bethesda Maryland Recruiting
Dana Farber Cancer Institute Boston Massachusetts Recruiting
Henry Ford Health System Detroit Michigan Recruiting
Trinity Health Michigan Heart - Ann Arbor Campus Ypsilanti Michigan Recruiting
Washington University in St Louis St Louis Missouri Recruiting
Dartmouth Hitchcock Medical Center Lebanon New Hampshire Recruiting
John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey Recruiting
Roswell Park Comprehensive Cancer Center Buffalo New York Recruiting
New York Presbyterian - Weill Cornell New York New York Recruiting
University of Rochester Medical Center Rochester New York Recruiting
Einstein-Montefiore Medical Center The Bronx New York Recruiting
Atrium Health Charlotte North Carolina Recruiting
Novant Health Charlotte Charlotte North Carolina Recruiting
Carolina Oncology Specialists Charlotte North Carolina Recruiting
Novant Health Winston Salem Winston-Salem North Carolina Recruiting
Atrium Health Wake Forest Baptist Comprehensive Cancer Center Winston-Salem North Carolina Recruiting
Gabrail Cancer Center Canton Ohio Recruiting
Miami Valley Hospital South Centerville Ohio Recruiting
Oncology Hematology Care Cincinnati Ohio Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio Recruiting

+ 222 more sites — see the full list on the official registry below.

More Janssen Research & Development, LLC trials in the UK

Other trials for the same condition

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 NCT06852222 on ClinicalTrials.gov ↗ ← All trials in the UK