Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT07295951
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-07-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-12-09', 'studyFirstSubmitQcDate': '2025-12-09', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Dose Excreted in Urine (feu)', 'timeFrame': 'Up to Day 28', 'description': 'Total amount excreted into the urine, expressed as a percentage of the administered dose will be reported.'}, {'measure': 'Percentage of Dose Excreted in Feces (fef)', 'timeFrame': 'Up to Day 28', 'description': 'Total amount excreted into the feces expressed as a percentage of the administered dose will be reported.'}, {'measure': 'Amount Excreted in Urine (Aeu)', 'timeFrame': 'Up to Day 28', 'description': 'Aeu defined as the total amount of bleximenib and radioactivity excreted into the urine will be reported.'}, {'measure': 'Amount Excreted in Feces (Aef)', 'timeFrame': 'Up to Day 28', 'description': 'Aef defined as the total amount of bleximenib and radioactivity excreted into the feces will be reported.'}, {'measure': 'Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUC0-t)', 'timeFrame': 'Cycle 1 Day 1, and Cycle 1 Day 2 (Cycle duration=28 days)', 'description': 'AUC0-t in whole blood and plasma will be reported.'}, {'measure': 'Maximum Observed Concentration (Cmax)', 'timeFrame': 'Cycle 1 Day 1, and Cycle 1 Day 2 (Cycle duration=28 days)', 'description': 'Maximum observed concentration in whole blood and plasma will be determined.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 58 days', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Lymphoblastic Leukemia', 'Acute Leukemias', 'Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Body weight greater than or equal to (\\>=) 40 kilograms (kg)\n* 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\n* Eastern cooperative oncology group (ECOG) performance status grade of 0 or 1\n* Regular bowel movements (that is \\[i.e.\\], average production of at least one stool every 2 days)\n* 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\n\nExclusion criteria:\n\n* Acute promyelocytic leukemia or diagnosis of Down syndrome associated leukemia, according to world health organization (WHO) 2016 criteria\n* Active central nervous system (CNS) disease\n* Recipient of solid organ transplant\n* 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\n* 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'}, 'identificationModule': {'nctId': 'NCT07295951', 'briefTitle': 'A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'An Open-Label Study to Investigate the Absorption, Metabolism, And Excretion (AME) Of 14C-Bleximenib (JNJ-75276617) in Participants With Acute Leukemia', 'orgStudyIdInfo': {'id': '75276617ALE1006'}, 'secondaryIdInfos': [{'id': '75276617ALE1006', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bleximenib', 'description': '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.', 'interventionNames': ['Drug: 14C-bleximenib', 'Drug: bleximenib']}], 'interventions': [{'name': '14C-bleximenib', 'type': 'DRUG', 'otherNames': ['JNJ-75276617'], 'description': '14C-bleximenib will be administered orally.', 'armGroupLabels': ['Bleximenib']}, {'name': 'bleximenib', 'type': 'DRUG', 'otherNames': ['JNJ-75276617'], 'description': 'Non-radiolabeled bleximenib will be administered orally.', 'armGroupLabels': ['Bleximenib']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M20 4BX', 'city': 'Manchester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'The Christie NHS Foundation Trust Christie Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'centralContacts': [{'name': 'Study Contact', 'role': 'CONTACT', 'email': 'Participate-In-This-Study1@its.jnj.com', 'phone': '844-434-4210'}], 'overallOfficials': [{'name': 'Janssen Research & Development, LLC Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Research & Development, LLC'}]}, 'ipdSharingStatementModule': {'url': 'https://innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency', 'ipdSharing': 'YES', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}