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

Official record

Identifier

NCT07295951

Recruiting locations

country

United Kingdom

Interventions studied

14C-bleximenibbleximenib

Lead sponsor

Janssen Research & Development, LLC

Target enrolment

10 participants

Study type

INTERVENTIONAL

Phase

Phase 1

Status

Recruiting

First posted

Dec 22, 2025

Last updated on the registry

Jul 31, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion criteria:

* Body weight greater than or equal to (\>=) 40 kilograms (kg)
* Relapsed or refractory (R/R) acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A), nucleophosmin 1 (NPM1), nucleoporin 98 (NUP98) or nucleoporin 214 (NUP214) gene alterations, and has exhausted, or is ineligible for available therapeutic options
* Eastern cooperative oncology group (ECOG) performance status grade of 0 or 1
* Regular bowel movements (that is \[i.e.\], average production of at least one stool every 2 days)
* A woman 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

Exclusion criteria:

* Acute promyelocytic leukemia or diagnosis of Down syndrome associated leukemia, according to world health organization (WHO) 2016 criteria
* Active central nervous system (CNS) disease
* Recipient of solid organ transplant
* 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
* Major surgery (e.g., requiring general anesthesia) within 2 weeks prior to first dose of study treatment or has not recovered from surgery or has major surgery planned during the time the participant is receiving study treatment

Indexed under

Leukemia