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Active Not Recruiting NCT05453903

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

Conditions: Leukemia, Myeloid, Acute

Sex: All
Ages: 12 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 196
Sponsor: Janssen Research & Development, LLC

Location: The University of Alabama at Birmingham Birmingham Alabama

Summary

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).

Eligibility Criteria

Inclusion Criteria: * Adolescent participants (defined as greater than or equal to \[\>=\] 12 and less than \[\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 Exclusion Criteria: * 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 (\\] 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05453903). StuddyBuddy aggregates publicly available trial information.