Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07295951

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

The Christie NHS Foundation Trust Christie Hospital

Manchester, United Kingdom, M20 4BX

Actively Recruiting

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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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