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An Open-Label Study To Investigate The Absorption, Metabolism, And Excretion Of 14C-Bleximenib In Participants With Acute Leukemia
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Phase 1
Age: 18 Years +
All Genders
ID07295951
A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia
Led by Janssen Research & Development, LLC
Updated on 2026-06-05
10 Participants Needed
1 Research Site
4 weeks
Total Duration
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- AI-Summary
- Brief Title
- Who Can Participate
- AI-Screening
- Your Study Journey
- Trial Site Locations
- Research Team
- How is the study designed?
- Similar Trials
- Frequently Asked Questions
AI-Summary
What This Trial Is About
Researchers are studying how the body absorbs, processes, and removes a radiolabeled form of bleximenib in adults with acute leukemia, a fast-growing blood cancer marked by many immature white blood cells in the bone marrow. This phase 1 trial aims to understand the metabolism and excretion of the drug to provide detailed information on its behavior in the body. The study is sponsored by Janssen Research & Development, LLC and focuses on participants with specific genetic alterations in their leukemia.
Participants will receive a single oral dose of radiolabeled 14C-bleximenib on the first day of treatment, followed by a recommended phase 2 dose of non-radiolabeled bleximenib starting the next day. This non-radiolabeled drug will be taken daily throughout the 28-day first cycle. Those who qualify may continue treatment in a related follow-up study for ongoing administration of non-radiolabeled bleximenib.
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During the study, participants will have their urine and feces collected to measure how much of the drug is excreted over 28 days. Blood samples will be taken to track drug concentration levels on days 1 and 2 of the first cycle. Researchers will monitor for any side effects up to 58 days after dosing. The total participation time varies but includes detailed assessments of drug absorption, metabolism, and safety throughout the first treatment cycle.
CONDITIONS
Brief Title
A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia
Who Can Participate
Age: 18 Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Body weight greater than or equal to 40 kilograms
- Relapsed or refractory acute leukemia with specific gene alterations (KMT2A, NPM1, NUP98, or NUP214)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Regular bowel movements, at least one stool every two days
- Women of childbearing potential must have a negative pregnancy test before starting treatment
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You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia or Down syndrome associated leukemia
- Active central nervous system disease
- Recipient of a solid organ transplant
- Ongoing toxicity from previous cancer treatment except for certain mild conditions
- Major surgery within two weeks before starting treatment or planned during the study period
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On this page
- AI-Summary
- Brief Title
- Who Can Participate
- AI-Screening
- Your Study Journey
- Trial Site Locations
- Research Team
- How is the study designed?
- Similar Trials
- Frequently Asked Questions
Sponsors
J
Janssen Research & Development, LLC
Lead Sponsor
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