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Recruiting NCT07295951

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

Phase I Interventional Acute Lymphoblastic Leukemia Acute Leukemias Acute Myeloid Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 14C-bleximenib, bleximenib.
Who it may be relevant to
Registry conditions: Acute Lymphoblastic Leukemia, Acute Leukemias, Acute Myeloid Leukemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Drug 14C-bleximenib
    14C-bleximenib will be administered orally.
  • Drug bleximenib
    Non-radiolabeled bleximenib will be administered orally.

Primary outcome measures

  • Percentage of Dose Excreted in Urine (feu) [Time frame: Up to Day 28]
  • Percentage of Dose Excreted in Feces (fef) [Time frame: Up to Day 28]
  • Amount Excreted in Urine (Aeu) [Time frame: Up to Day 28]
  • Amount Excreted in Feces (Aef) [Time frame: Up to Day 28]
  • Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUC0-t) [Time frame: Cycle 1 Day 1, and Cycle 1 Day 2 (Cycle duration=28 days)]
  • Maximum Observed Concentration (Cmax) [Time frame: Cycle 1 Day 1, and Cycle 1 Day 2 (Cycle duration=28 days)]
Secondary outcome measures (1)
  • Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: Up to 58 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • The Christie NHS Foundation Trust Christie Hospital — Manchester

Identifiers

NCT: NCT07295951 · 75276617ALE1006 · 75276617ALE1006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗