Acute Lymphoblastic LeukemiaPhase 1NCT07295951
A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia
A Phase 1 study testing 14C-bleximenib and bleximenib in people with Acute Lymphoblastic Leukemia and Acute Leukemias, run by Janssen Research & Development, LLC at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Acute Leukemias, Acute Myeloid Leukemia
- What is being tested?
- 14C-bleximenib and bleximenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Nov 2025to 21 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Christie NHS Foundation Trust Christie Hospital
Manchester, M20 4BX
About this study
Official title: An Open-Label Study to Investigate the Absorption, Metabolism, And Excretion (AME) Of 14C-Bleximenib (JNJ-75276617) in Participants With Acute Leukemia
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).
- Being tested
- 14C-bleximenib, bleximenib
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14C-bleximenibDrug
Also called JNJ-75276617
14C-bleximenib will be administered orally.
bleximenibDrug
Also called JNJ-75276617
Non-radiolabeled bleximenib will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Bleximenib | Experimental | Participants will receive a single oral dose of 14C-bleximenib on Cycle 1 Day 1. The recommended Phase 2 dose (RP2D) of bleximenib will start on Cycle 1 Day 2 with non-radiolabeled bleximenib and will continue until the end of Cycle 1 (cycle duration=28 days), with subsequent roll-over for eligible participants to 75276617ALE1001 (NCT04811560) for continued non-radiolabeled bleximenib administration as appropriate. Receives: Drug: 14C-bleximenib; Drug: bleximenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Dose Excreted in Urine (feu)
Total amount excreted into the urine, expressed as a percentage of the administered dose will be reported.
Measured: Up to Day 28
Percentage of Dose Excreted in Feces (fef)
Total amount excreted into the feces expressed as a percentage of the administered dose will be reported.
Measured: Up to Day 28
Amount Excreted in Urine (Aeu)
Aeu defined as the total amount of bleximenib and radioactivity excreted into the urine will be reported.
Measured: Up to Day 28
Amount Excreted in Feces (Aef)
Aef defined as the total amount of bleximenib and radioactivity excreted into the feces will be reported.
Measured: Up to Day 28
Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUC0-t)
AUC0-t in whole blood and plasma will be reported.
Measured: Cycle 1 Day 1, and Cycle 1 Day 2 (Cycle duration=28 days)
Maximum Observed Concentration (Cmax)
Maximum observed concentration in whole blood and plasma will be determined.
Measured: Cycle 1 Day 1, and Cycle 1 Day 2 (Cycle duration=28 days)
Secondary outcomes (1)
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the study treatment. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important.
Measured: Up to 58 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start18 Nov 2025
- Primary completion21 Jul 2026
- Study completion21 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295951
- Sponsor's protocol ID
- 75276617ALE1006
- Other IDs
- 75276617ALE1006
- Status last verified
- Sep 2026
- First submitted
- 9 Dec 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Investigate the Absorption, Metabolism, And Excretion (AME) Of 14C-Bleximenib (JNJ-75276617) in Participants With Acute Leukemia
- ClinicalTrials.gov ID
- NCT07295951
- Acronym / sponsor ID
- 75276617ALE1006
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- 21 Jul 2026 (actual)
- Study completion
- 21 Jul 2026 (actual)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bleximenib | Experimental | Drug: 14C-bleximenib, Drug: bleximenibParticipants will receive a single oral dose of 14C-bleximenib on Cycle 1 Day 1. The recommended Phase 2 dose (RP2D) of bleximenib will start on Cycle 1 Day 2 with non-radiolabeled bleximenib and will continue until the end of Cycle 1 (cycle duration=28 days), with subsequent roll-over for eligible participants to 75276617ALE1001 (NCT04811560) for continued non-radiolabeled bleximenib administration as appropriate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 14C-bleximenibAlso: JNJ-7527661714C-bleximenib will be administered orally. | Drug | Bleximenib |
| bleximenibAlso: JNJ-75276617Non-radiolabeled bleximenib will be administered orally. | Drug | Bleximenib |
Primary outcome
Percentage of Dose Excreted in Urine (feu)
Time frame: Up to Day 28
Total amount excreted into the urine, expressed as a percentage of the administered dose will be reported.
Percentage of Dose Excreted in Feces (fef)
Time frame: Up to Day 28
Total amount excreted into the feces expressed as a percentage of the administered dose will be reported.
Amount Excreted in Urine (Aeu)
Time frame: Up to Day 28
Aeu defined as the total amount of bleximenib and radioactivity excreted into the urine will be reported.
Amount Excreted in Feces (Aef)
Time frame: Up to Day 28
Aef defined as the total amount of bleximenib and radioactivity excreted into the feces will be reported.
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)
AUC0-t in whole blood and plasma will be reported.
Maximum Observed Concentration (Cmax)
Time frame: Cycle 1 Day 1, and Cycle 1 Day 2 (Cycle duration=28 days)
Maximum observed concentration in whole blood and plasma will be determined.
1 secondary outcome
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 58 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 14C-bleximenib and bleximenib in people with Acute Lymphoblastic Leukemia and Acute Leukemias, run by Janssen Research & Development, LLC at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Dose Excreted in Urine (feu) (time frame: Up to Day 28). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.