RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 Acute Myeloid Leukemia (AML) with a mutation in the NPM1 or KMT2A gene.

Official Title

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

Quick Facts

Study Start:2025-06-04
Study Completion:2029-08-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06852222

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Be 18 years of age or older at the time of informed consent
  2. * 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
  3. * 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) 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.
  4. * Participants must have adequate hepatic and renal function
  5. * 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
  6. * 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
  7. * 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
  1. * Diagnosis of acute promyelocytic leukemia (APL)
  2. * Known active leukemic involvement of the central nervous system (CNS)
  3. * Recipient of solid organ transplant
  4. * 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
  5. * Active infectious hepatitis
  6. * Live, attenuated vaccine within 4 weeks of randomization
  7. * Known allergies, hypersensitivity, or intolerance of bleximenib, azacitidine, or venetoclax excipients

Contacts and Locations

Study Contact

Study Contact
CONTACT
844-434-4210
Participate-In-This-Study1@its.jnj.com

Principal Investigator

Janssen Research & Development, LLC Clinical Trial
STUDY_DIRECTOR
Janssen Research & Development, LLC

Study Locations (Sites)

University of Arkansas at Little Rock
Little Rock, Arkansas, 72204
United States
Orlando Health Cancer Institute
Orlando, Florida, 32806
United States
Moffit Cancer center
Tampa, Florida, 33612
United States
Cleveland Clinic Florida
Weston, Florida, 33331
United States
Norton Cancer Institute
Louisville, Kentucky, 40207
United States
Washington University in St Louis
St Louis, Missouri, 63130
United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
United States
Atrium Health
Charlotte, North Carolina, 28204
United States
Gabrail Cancer Center
Canton, Ohio, 44718
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
Providence Oncology and Hematology Care Clinic Westside
Portland, Oregon, 97225
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
University of Tennessee
Knoxville, Tennessee, 37920
United States
Baylor University Medical Center
Dallas, Texas, 75246
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: Janssen Research & Development, LLC

  • Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-04
Study Completion Date2029-08-15

Study Record Updates

Study Start Date2025-06-04
Study Completion Date2029-08-15

Terms related to this study

Additional Relevant MeSH Terms

  • Leukemia, Myeloid, Acute