Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 11:20 PM
Study NCT ID:
NCT06656234
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-24
First Post:
2024-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness and Safety of Glofitamab in Real-World Clinical Practice Among Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Prospective, Observational, Multicenter Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000720108', 'term': 'glofitamab'}, {'id': 'C543332', 'term': 'obinutuzumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2028-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-23', 'studyFirstSubmitDate': '2024-10-23', 'studyFirstSubmitQcDate': '2024-10-23', 'lastUpdatePostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival (PFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma', 'timeFrame': 'Baseline up to end of study (EOS) (approximately 48 months)'}], 'secondaryOutcomes': [{'measure': 'Complete Response Rate (CRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma', 'timeFrame': 'Baseline up to EOS (approximately 48 months)'}, {'measure': 'Overall Response Rate (ORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma', 'timeFrame': 'Baseline up to EOS (approximately 48 months)'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'From the date of the first occurrence of a documented CR or partial response (PR) to the date of progression, relapse, or death from any cause, whichever occurs first (up to approximately 48 months)'}, {'measure': 'Duration of Complete Response (DoCR)', 'timeFrame': 'From the date of the first occurrence of a documented CR to the date of progression, relapse, or death from any cause, whichever occurs first (up to approximately 48 months)'}, {'measure': 'Time to Next Treatment (TTNT)', 'timeFrame': 'From the start of glofitamab treatment to the initiation of next-line treatment (up to approximately 48 months)'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From the start of glofitamab treatment until the date of death from any cause (up to approximately 48 months)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diffuse Large B Cell Lymphoma (DLBCL)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the the efficacy and safety in the real-world settings of glofitamab among Chinese R/R DLBCL participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants who will be treated with glofitamab (known as being recommended and having the intention to be treated with glofitamab at the time of signing informed consent) or have initiated glofitamab treatment within 6 months prior to enrollment and after the indication approval will be observed in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Be diagnosed as R/R DLBCL\n* Participants who will be treated with glofitamab (known as being recommended and having the intention to be treated with glofitamab at the time of signing informed consent) or have initiated glofitamab treatment within 6 months prior to enrollment and after the indication approval will be observed in this study.\n\nExclusion Criteria:\n\n* Any other reason that, in the investigator's opinion, makes the participant unsuitable to participate in this study."}, 'identificationModule': {'nctId': 'NCT06656234', 'briefTitle': 'The Effectiveness and Safety of Glofitamab in Real-World Clinical Practice Among Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Prospective, Observational, Multicenter Study', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'The Effectiveness and Safety of Glofitamab in Real-World Clinical Practice Among Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Prospective, Observational, Multicenter Study', 'orgStudyIdInfo': {'id': 'GloReal'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': "Participants with relapsed or refractory (R/R) DLBCL who have started receiving glofitamab at physician's discretion in accordance with local clinical practice and/or labeling will be observed for safety and efficacy until death, withdrawal of consent, loss to follow-up or end of study whichever occurs first (up to approximately 4 years).", 'interventionNames': ['Drug: Glofitamab', 'Drug: Obinutuzumab']}], 'interventions': [{'name': 'Glofitamab', 'type': 'DRUG', 'description': 'Glofitamab will be administered at the discretion of the physician per local clinical practice and local labeling.', 'armGroupLabels': ['Cohort 1']}, {'name': 'Obinutuzumab', 'type': 'DRUG', 'description': 'Obinutuzumab pre-treatment is given intravenously at a dose of 1g on Cycle 1 Day 1.', 'armGroupLabels': ['Cohort 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Weili Zhao', 'role': 'CONTACT', 'email': 'zwl_trial@163.com', 'phone': '008602164370045'}], 'facility': 'Ruijin Hospital, Shanghai JiaoTong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Weili Zhao', 'role': 'CONTACT', 'email': 'zwl_trial@163.com', 'phone': '008602164370045'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Zhao Weili', 'investigatorAffiliation': 'Ruijin Hospital'}}}}