Go back to trials list
A Phase 1b Study of Bleximenib in Combination With AML-Directed Therapies for Participants With Acute Myeloid Leukemia Harboring KMT2A or NPM1 Alterations
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).
Trial Eligibility
Inclusion 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 Exclusion Criteria: * 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
Study Info
Organization
Janssen Research & Development, LLC
Primary Outcome
Number of Participants with Adverse Events (AEs)
Interventions
Locations Recruiting
The University of Alabama at Birmingham
United States, Alabama, Birmingham
City of Hope
United States, California, Duarte
Massachusetts General Hospital
United States, Massachusetts, Boston
Albert Einstein College Of Medicine
United States, New York, New York
Novant Health
United States, North Carolina, Charlotte
Interested in joining this trial?
Our dedicated patient navigators are here to guide you through the validation and enrollment process with ease.
![newsletter icon](https://static.healthtree.org/icons/newsletter-icon.png)
Get the latest thought leadership on your Acute Myeloid Leukemia delivered straight to your inbox
Subscribe to the weekly newsletter for news, stories, clinical trial updates, and helpful resources and events with cancer experts.
Thanks to our HealthTree Community for Acute Myeloid Leukemia Sponsors:
![Abbvie](https://firebasestorage.googleapis.com/v0/b/healthtree-production.appspot.com/o/gallery%2Fpublic%2Fabbvie%20bigger_c5e4f4af-fb3c-45ca-b9f0-831fb4c5f968.jpeg?alt=media)
![Astellas Pharma](https://firebasestorage.googleapis.com/v0/b/healthtree-production.appspot.com/o/university%2Fpublic%2Fshared%2Fastellas%20fo%20realz-100_8fd8c5cb-3421-4cfd-8aa6-07a70f67acf7.jpg?alt=media)
![Servier](https://firebasestorage.googleapis.com/v0/b/healthtree-production.appspot.com/o/gallery%2Fpublic%2Fservier_6f4f6f05-7255-45f8-8f3d-a07651617cbe.png?alt=media)