At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- 14C-bleximenib (drug), bleximenib (drug)
- How long the study runs
- Study runs about 8 months (dates as stated)
- About the drug or intervention
- 14C-bleximenib — drug: 14C-bleximenib will be administered orally. · bleximenib — drug: Non-radiolabeled bleximenib will be administered orally.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 6
- Started
- 2025-11-18
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for acute lymphoblastic leukemia
- • Phase1 - 6 participants
- • 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)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with acute lymphoblastic leukemia
Where?
- • Manchester - The Christie NHS Foundation Trust Christie Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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).
Acute Lymphoblastic LeukemiaAcute LeukemiasAcute Myeloid Leukemia
How this trial compares with your answers
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What we know so far
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
have a negative
What the study is looking for
- ✓Body weight greater than or equal to (\>=) 40 kilograms (kg)
- ✓activity scale (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...
Who cannot take part
- ✗Acute promyelocytic leukemia or diagnosis of Down syndrome associated leukemia, according to world health...
- ✗Active central nervous system (CNS) disease
- ✗Recipient of solid organ transplant
- ✗Any toxicity (except for alopecia, stable peripheral neuropathy, thrombocytopenia, neutropenia, anemia) from...
See the full 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
Where Is This Study? (1 UK site)
The Christie NHS Foundation Trust Christie Hospital
Manchester M20 4BX, United Kingdom
Data sourced from ClinicalTrials.gov · Last verified: 2026-09