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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT06852222

Public ClinicalTrials.gov record NCT06852222. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 10, 2026, 9:42 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Study identification

NCT ID
NCT06852222
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Janssen Research & Development, LLC
Industry
Enrollment
600 participants

Conditions and interventions

Interventions

  • Azacitidine (AZA) Drug
  • Bleximenib Drug
  • Placebo Drug
  • Venetoclax (VEN) Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 3, 2025
Primary completion
Jun 21, 2029
Completion
Aug 14, 2029
Last update posted
May 7, 2026

2025 – 2029

United States locations

U.S. sites
48
U.S. states
23
U.S. cities
40
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35294 Recruiting
Cancer Treatment Center of America Phoenix Goodyear Arizona 85338 Recruiting
The University of Arizona Cancer Center Tucson Arizona 85724 Recruiting
University of Arkansas at Little Rock Little Rock Arkansas 72204 Recruiting
City of Hope Duarte California 91010 Recruiting
Medical Oncology Hematology Consultants, PA Newark Delaware 19713 Recruiting
Florida Cancer Specialists & Research Institute Fort Myers Florida 33901 Recruiting
Jupiter Research Jupiter Florida 33458 Recruiting
Orlando Health Cancer Institute Orlando Florida 32806 Recruiting
Moffit Cancer center Tampa Florida 33612 Recruiting
Cleveland Clinic Florida Weston Florida 33331 Recruiting
University of Chicago Medicine Chicago Illinois 60637 Recruiting
Illinois Cancer Specialists Niles Illinois 60714 Recruiting
University of Kentucky Markey Cancer Center Lexington Kentucky 40536 Recruiting
UofL Health Brown Cancer Center Louisville Kentucky 40202 Recruiting
Norton Cancer Institute Louisville Kentucky 40207 Recruiting
Mary Bird Perkins Cancer Center Baton Rouge Louisiana 70809 Recruiting
Dana Farber Cancer Institute Boston Massachusetts 02115 Recruiting
Henry Ford Health System Detroit Michigan 48202 Recruiting
Trinity Health Michigan Heart - Ann Arbor Campus Ypsilanti Michigan 48106 Recruiting
Washington University in St Louis St Louis Missouri 63130 Recruiting
Dartmouth Hitchcock Medical Center Lebanon New Hampshire 03756 Recruiting
John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey 07601 Recruiting
Roswell Park Comprehensive Cancer Center Buffalo New York 14263 Recruiting
New York Presbyterian - Weill Cornell New York New York 10065 Recruiting
University of Rochester Medical Center Rochester New York 14642 Recruiting
Einstein-Montefiore Medical Center The Bronx New York 10467 Recruiting
Atrium Health Charlotte North Carolina 28204 Recruiting
Novant Health Charlotte Charlotte North Carolina 28204 Recruiting
Oncology Specialists of Charlotte Charlotte North Carolina 28207 Recruiting
Novant Health Winston Salem Winston-Salem North Carolina 27106 Recruiting
Atrium Health Wake Forest Baptist Comprehensive Cancer Center Winston-Salem North Carolina 27157 Recruiting
Gabrail Cancer Center Canton Ohio 44718 Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio 44106 Recruiting
Cleveland Clinic Cleveland Ohio 44195 Recruiting
Providence Portland Medical Center Portland Oregon 97213 Recruiting
Providence Oncology and Hematology Care Clinic Westside Portland Oregon 97225 Recruiting
Thomas Jefferson University Philadelphia Pennsylvania 19107 Recruiting
Fox Chase Cancer Center Philadelphia Pennsylvania 19111 Recruiting
University of Pittsburgh Medical Center Pittsburgh Pennsylvania 15260 Recruiting
University of Tennessee Knoxville Tennessee 37920 Recruiting
Vanderbilt Ingram Cancer Center Nashville Tennessee 37232 Recruiting
Baylor University Medical Center Dallas Texas 75246 Recruiting
MD Anderson Cancer Center Houston Texas 77030 Recruiting
Texas Oncology - Northeast Tyler Texas 75702 Recruiting
Virginia Commonwealth University - Massey Cancer Center Richmond Virginia 23298 Recruiting
Swedish Cancer Institute Seattle Washington 98104 Recruiting
Fred Hutchinson Cancer Center Seattle Washington 98109 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 200 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06852222, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 7, 2026 · Synced May 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06852222 live on ClinicalTrials.gov.

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