Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-24 @ 5:45 PM
Study NCT ID:
NCT06794268
Status:
RECRUITING
Last Update Posted:
2025-02-24
First Post:
2025-01-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Patients With Relapsed/Refractory Follicular Lymphoma Treated With Liso-cel (Lisocabtagene Maraleucel) in the Post Marketing Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2044-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2025-01-20', 'studyFirstSubmitQcDate': '2025-01-20', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2044-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events (AEs) of interest', 'timeFrame': 'Up to 15 years', 'description': 'AEs of interest include:\n\n* Secondary malignancies\n* Cytokine release syndrome (CRS) Grade ≥ 3\n* Neurotoxicity Grade ≥ 3\n* Prolonged cytopenias\n* Pregnancy outcome\n* Tumor lysis syndrome (TLS) Grade ≥ 3\n* Serious infections (ie, those requiring treatment)\n* Organ toxicities Grade ≥ 3\n* Hemophagocytic lymphohistiocytosis (HLH)/ macrophage activation syndrome (MAS)-like toxicities\n* Aggravated graft-versus-host disease (GvHD)'}, {'measure': 'Incidence of other adverse events (AEs) of interest', 'timeFrame': 'Up to 15 years', 'description': 'Other clinically important events that have not yet been identified as part of the liso-cel safety profile'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'Up to 15 years'}, {'measure': 'Overall response rate (ORR)', 'timeFrame': 'Up to 15 years'}, {'measure': 'Complete remission rate (CRR)', 'timeFrame': 'Up to 15 years'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'Up to 15 years'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Up to 15 years'}, {'measure': 'Time to next treatment (TTNT)', 'timeFrame': 'Up to 15 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Follicular Lymphoma'], 'conditions': ['Follicular Lymphoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to characterise the long-term safety of lisocabtagene maraleucel, focusing on patients treated in the approved follicular lymphoma (FL) indication, and will be part of post-marketing liso-cel pharmacovigilance activities'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include adults with relapsed/refractory follicular lymphoma that are being treated with lisocabtagene maraleucel and are registered within the Center for International Blood and Marrow Transplant Research (CIBMTR) registry.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Participants must have been treated in the post-marketing setting with at least 1 infusion of lisocabtagene maraleucel (liso-cel) used for the treatment of relapsed/refractory (R/R) follicular lymphoma (FL), including FL Grade 1, Grade 2 and Grade 3a, within the FDA-approved indication and dosage per the United States Prescribing Information (USPI) and product specifications approved for commercial release in the USA\n\nExclusion Criteria:\n\n* Participants known to be participating in investigational studies at the time of liso-cel, infusion\n* Participants treated with liso-cel for the treatment of R/R FL Grade 3b\n* Participants treated with non-conforming chimeric antigen receptor (CAR) T-cell product'}, 'identificationModule': {'nctId': 'NCT06794268', 'briefTitle': 'A Study to Patients With Relapsed/Refractory Follicular Lymphoma Treated With Liso-cel (Lisocabtagene Maraleucel) in the Post Marketing Setting', 'organization': {'class': 'INDUSTRY', 'fullName': 'Juno Therapeutics, Inc., a Bristol-Myers Squibb Company'}, 'officialTitle': 'Non-interventional Cohort Study of Patients Treated With Liso-cel (Lisocabtagene Maraleucel) for Relapsed/Refractory Follicular Lymphoma in the Postmarketing Setting', 'orgStudyIdInfo': {'id': 'CA082-1175'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants receiving lisocabtagene maraleucel treatment', 'interventionNames': ['Biological: Lisocabtagene maraleucel']}], 'interventions': [{'name': 'Lisocabtagene maraleucel', 'type': 'BIOLOGICAL', 'description': 'As per product label', 'armGroupLabels': ['Participants receiving lisocabtagene maraleucel treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'CIBMTR', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'centralContacts': [{'name': 'BMS Study Connect Contact Center www.BMSStudyConnect.com', 'role': 'CONTACT', 'email': 'Clinical.Trials@bms.com', 'phone': '855-907-3286'}, {'name': 'First line of the email MUST contain NCT # and Site #.', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Juno Therapeutics, Inc., a Bristol-Myers Squibb Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}