A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies

Description

The purpose of this study is to determine the recommended Phase 2 dose (RP2D) candidate(s) of bleximenib in combination with AML directed therapies (dose selection) and further to evaluate safety and tolerability of bleximenib in combination with AML directed therapies at the RP2D(s) (dose expansion).

Conditions

Leukemia, Myeloid, Acute

Study Overview

Study Details

Study overview

The purpose of this study is to determine the recommended Phase 2 dose (RP2D) candidate(s) of bleximenib in combination with AML directed therapies (dose selection) and further to evaluate safety and tolerability of bleximenib in combination with AML directed therapies at the RP2D(s) (dose expansion).

A Phase 1b Study of Bleximenib in Combination With AML-Directed Therapies for Participants With Acute Myeloid Leukemia Harboring KMT2A or NPM1 Alterations

A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies

Condition
Leukemia, Myeloid, Acute
Intervention / Treatment

-

Contacts and Locations

Birmingham

The University of Alabama at Birmingham, Birmingham, Alabama, United States, 35233

Duarte

City of Hope, Duarte, California, United States, 91010

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

New York

Albert Einstein College Of Medicine, New York, New York, United States, 10461

Charlotte

Novant Health, Charlotte, North Carolina, United States, 28204

Winston-Salem

Novant Health Forsyth Medical Center, Winston-Salem, North Carolina, United States, 27103

Houston

MD Anderson, Houston, Texas, United States, 77030

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Diagnosis of AML according to World Health Organization (WHO) criteria: a) De novo or secondary AML; b) relapsed /refractory (Arm A only); c) harboring NPM1 / KMT2A alterations
  • * Pretreatment clinical laboratory values meeting the following criteria -listed below: White blood cell (WBC) count: less than or equal to \<=25 x 10\^9 per liter (/L), adequate liver and renal function
  • * ECOG performance status grade of 0, 1 or 2
  • * A woman of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment
  • * Must sign an informed consent form (ICF) indicating participant understands the purpose of the study and procedures required for the study and is willing to participate in the study.
  • * Willing and able to adhere to the prohibitions and restrictions specified in this protocol
  • * Acute promyelocytic leukemia according to WHO 2016 criteria
  • * Leukemic involvement of the central nervous system
  • * Recipient of solid organ transplant
  • * Cardiovascular disease that is uncontrolled, increases risk for Torsades de Pointes or that was diagnosed within 6 months prior to the first dose of study treatment including, but not limited to:(a) Myocardial infarction; (b) Severe or unstable angina; (c) Clinically significant cardiac arrhythmias, including bradycardia (less than \[\<\] 50 beats per minute); (d) Uncontrolled (persistent) hypertension: (example, blood pressure greater than \[\>\] 140/90 millimeters of mercury \[mm Hg\]; (e) Acute neurologic events such as stroke or transient ischemic attack, intracranial or subarachnoid hemorrhage, intracranial trauma; (f) Venous thromboembolic events (example, pulmonary embolism) within 1 month prior to the first dose of study treatment ;(g)Congestive heart failure (NYHA class III to IV); (h) Pericarditis or clinically significant pericardial effusion; (i) Myocarditis; (j) Endocarditis (k) Clinically significant hypokalemia, hypomagnesemia, hypocalcemia (corrected for hypoalbuminemia)
  • * Any toxicity (except for alopecia, stable peripheral neuropathy, thrombocytopenia, neutropenia, anemia) from previous anticancer therapy that has not resolved to baseline or to grade 1 or less
  • * Pulmonary compromise that requires the need for supplemental oxygen use to maintain adequate oxygenation

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Janssen Research & Development, LLC,

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

Study Record Dates

2026-03-05