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

Running, not enrolling · Phase 1

Conditions studied: Leukemia, Myeloid, Acute

In brief

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).

Key facts

Study ID

NCT05453903

Run by

Janssen Research & Development, LLC

People needed

196

Starts

2022-10-04

Expected to finish

2027-03-03

Last updated by the study team

2026-07-06

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adolescent participants (defined as greater than or equal to [>=] 12 and less than [<] 18 years of age) are only eligible for the relapsed/refractory (R/R) cohort (Arm A, cohort A4)
• Diagnosis of AML according to World Health Organization (WHO) criteria: a) De novo or secondary AML; b) relapsed/refractory (Arm A only); c) harboring KMT2A, NPM1, NUP98, or NUP214 alterations; d) Participants may receive emergency leukapheresis and/or cytarabine as cytoreductive therapy according to local practice guidelines
• Pretreatment clinical laboratory values meeting the following criteria -listed below: White blood cell (WBC) count: less than or equal to (<=) 25*10\^9 per liter (/L), adequate liver and renal function
• Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2. Adolescent participants only: Performance status >70 by Lansky scale (for participants <16 years of age) or >70 Karnofsky scale (for participants >16 years of age)
• A female 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 (or their legally authorized representative) 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

You may not qualify if…

• Acute promyelocytic leukemia, diagnosis of Down syndrome associated leukemia or juvenile myelomonocytic 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 (<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
• Participants with diagnosis of Fanconi anemia, Kostmann syndrome, Shwachman diamond syndrome, or any other known bone marrow failure syndrome

Where it is running

• The University of Alabama at Birmingham — Birmingham, Alabama, United States
• City of Hope — Duarte, California, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Albert Einstein College Of Medicine — New York, New York, United States
• Novant Health — Charlotte, North Carolina, United States
• Novant Health Forsyth Medical Center — Winston-Salem, North Carolina, United States
• MD Anderson — Houston, Texas, United States
• Monash Medical Centre — Clayton, Australia
• Peter MacCallum Cancer Centre — Melbourne, Australia
• Westmead Hospital — Westmead, Australia
• Princess Margaret Cancer Centre University Health Network — Toronto, Ontario, Canada
• Institut Paoli Calmettes — Marseille, France
• Chu Rennes Hopital Pontchaillou — Rennes, France
• Institut Universitaire du Cancer Toulouse Oncopole — Toulouse, France
• CHU de Tours - Hôpital de Bretonneau — Tours, France
• Charite Universitaetsmedizin Berlin — Berlin, Germany
• Universitatsklinikum Carl Gustav Carus Dresden — Dresden, Germany
• Universitaetsklinikum Heidelberg — Heidelberg, Germany
• Universitaetsklinikum Leipzig — Leipzig, Germany
• Universitatsklinikum Ulm — Ulm, Germany
• Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna — Bologna, Italy
• Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori — Meldola, Italy
• ASST Grande Ospedale Metropolitano Niguarda — Milan, Italy
• IRCCS Istituto Clinico Humanitas — Rozzano, Italy
• Hosp. de La Santa Creu I Sant Pau — Barcelona, Spain

Full record on ClinicalTrials.gov

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