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

RecruitingPhase 3

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2A Rearrangements or NPM1 Mutations Who Are Ineligible for Intensive Chemotherapy

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Janssen Research & Development, LLC · Participants: 600 · Started: Jun 4, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06852222

Locations in the U.S.

AlabamaUniversity of Alabama at Birmingham, Birmingham
ArizonaCancer Treatment Center of America Phoenix, Goodyear
The University of Arizona Cancer Center, Tucson
ArkansasUniversity of Arkansas at Little Rock, Little Rock
CaliforniaCity of Hope, Duarte
ColoradoRocky Mountain Cancer Centers, Aurora
DelawareMedical Oncology Hematology Consultants, PA, Newark
FloridaFlorida Cancer Specialists & Research Institute, Fort Myers
Jupiter Research, Jupiter
AdventHealth Medical Group Blood & Marrow Transplant at Orlando, Orlando
Orlando Health Cancer Institute, Orlando
Memorial Cancer Institute, Pembroke Pines
Moffit Cancer center, Tampa
Cleveland Clinic Florida, Weston
IllinoisUniversity of Chicago Medicine, Chicago
Illinois Cancer Specialists, Niles
KentuckyUniversity of Kentucky Markey Cancer Center, Lexington
Norton Cancer Institute, Louisville
UofL Health Brown Cancer Center, Louisville
LouisianaMary Bird Perkins Cancer Center, Baton Rouge
MarylandCenter for Cancer and Blood Disorders, Bethesda
MassachusettsBeth Israel Deaconess Medical Center, Boston
Dana Farber Cancer Institute, Boston
MichiganHenry Ford Health System, Detroit
Trinity Health Michigan Heart - Ann Arbor Campus, Ypsilanti
MissouriWashington University in St Louis, St Louis
New HampshireDartmouth Hitchcock Medical Center, Lebanon
New JerseyJohn Theurer Cancer Center at Hackensack University Medical Center, Hackensack
New YorkRoswell Park Comprehensive Cancer Center, Buffalo
Memorial Sloan Kettering Cancer Center, New York
New York Presbyterian - Weill Cornell, New York
University of Rochester Medical Center, Rochester
Einstein-Montefiore Medical Center, The Bronx
North CarolinaAtrium Health, Charlotte
Carolina Oncology Specialists, Charlotte
Novant Health Charlotte, Charlotte
Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem
Novant Health Winston Salem, Winston-Salem
OhioGabrail Cancer Center, Canton
Miami Valley Hospital South, Centerville
Oncology Hematology Care, Cincinnati
Cleveland Clinic, Cleveland
University Hospitals Cleveland Medical Center, Cleveland
OregonProvidence Oncology and Hematology Care Clinic Westside, Portland
Providence Portland Medical Center, Portland
PennsylvaniaFox Chase Cancer Center, Philadelphia
Thomas Jefferson University, Philadelphia
University of Pittsburgh Medical Center, Pittsburgh
TennesseeUniversity of Tennessee, Knoxville
Vanderbilt Ingram Cancer Center, Nashville
TexasBaylor University Medical Center, Dallas
Houston Methodist Cancer Center, Houston
MD Anderson Cancer Center, Houston
The University of Texas Health Science Center at Houston, Houston
Texas Oncology - Northeast, Tyler
UtahIntermountain Healthcare LDS Hospital, Salt Lake City
VirginiaVirginia Commonwealth University - Massey Cancer Center, Richmond
WashingtonFred Hutchinson Cancer Center, Seattle
Swedish Cancer Institute, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.