Actively Recruiting
A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
10
Participants Needed
1
Research Sites
33 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess how the body absorbs, breaks down (metabolism), and removes (excretes) radiolabeled bleximenib (a drug molecule that has been chemically bonded with a radioactive isotope which emits radiation making it easier to track in the body) in participants with acute leukemia (highly aggressive blood cancer typically characterized by large numbers of immature white blood cells in the bone marrow).
CONDITIONS
Official 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) and no remaining effective treatment options
- Eastern Cooperative Oncology Group (ECOG) performance status grade 0 or 1
- Regular bowel movements producing at least one stool every 2 days
- Women of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin test at screening and within 48 hours before first treatment dose
You will not qualify if you...
- Acute promyelocytic leukemia or Down syndrome-associated leukemia diagnosis per WHO 2016 criteria
- Active central nervous system disease
- Recipient of a solid organ transplant
- Unresolved toxicity from prior anticancer therapy, except alopecia, stable peripheral neuropathy, thrombocytopenia, neutropenia, or anemia
- Major surgery within 2 weeks before first treatment dose, incomplete recovery from surgery, or planned major surgery during study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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