Actively Recruiting
An Open-Label Study to Investigate the Absorption, Metabolism, and Excretion of 14C-Bleximenib in Participants with Acute Leukemia
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
10
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
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. 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
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants receive a single oral dose of radiolabeled 14C-bleximenib on Cycle 1 Day 1, followed by non-radiolabeled bleximenib starting Day 2 through the end of the 28-day cycle.
Daily dosing with multiple visits during Cycle 1
Duration - Up to 30 days after treatment
Participants are monitored for adverse events and safety for up to 58 days after treatment.
Periodic visits for safety assessments
Trial Site Locations
Total: 1 location
1
The Christie NHS Foundation Trust Christie Hospital
Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here