RecruitingPhase 1NCT07295951

A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia

An Open-Label Study to Investigate the Absorption, Metabolism, And Excretion (AME) Of 14C-Bleximenib (JNJ-75276617) in Participants With Acute Leukemia

Sponsor

Janssen Research & Development, LLC

Enrollment

10 participants

Start Date

Nov 18, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Acute Leukemias

Summary

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tracks how a drug called bleximenib moves through the body in patients with acute leukemia. Participants receive a single dose of a radioactively labeled version of the drug so researchers can trace exactly where it goes and how it is broken down. **You may be eligible if...** - You weigh at least 40 kg (about 88 lbs) - You have acute leukemia that has returned or is not responding to treatment - Your leukemia has specific gene changes (in KMT2A, NPM1, NUP98, or NUP214) - You have already tried available treatments or cannot tolerate them **You may NOT be eligible if...** - You have not exhausted or cannot tolerate standard treatments - You have significant organ dysfunction - You are pregnant or breastfeeding - You have certain other medical conditions that would make the radioactive dose unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG14C-bleximenib

14C-bleximenib will be administered orally.

DRUGbleximenib

Non-radiolabeled bleximenib will be administered orally.

Locations(1)

The Christie NHS Foundation Trust Christie Hospital

Manchester, United Kingdom

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NCT07295951

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