Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2026-02-07 @ 5:36 AM
Study NCT ID:
NCT06541327
Status:
RECRUITING
Last Update Posted:
2024-08-19
First Post:
2024-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cellular Immunotherapy for Relapsed or Refractory Lymphoma Data Collection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'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': 'D000076962', 'term': 'Receptors, Chimeric Antigen'}], 'ancestors': [{'id': 'D062165', 'term': 'Receptors, Artificial'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011948', 'term': 'Receptors, Antigen, T-Cell'}, {'id': 'D011946', 'term': 'Receptors, Antigen'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D018160', 'term': 'Receptors, Cytoplasmic and Nuclear'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2040-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-16', 'studyFirstSubmitDate': '2024-07-30', 'studyFirstSubmitQcDate': '2024-08-06', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2040-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Response (CR) Rate in 3 months', 'timeFrame': '3 months post CAR-T infusion', 'description': 'Complete Response rate in 3 months is defined as the incidence of subjects achieving complete remission (CR) within 3 months after CAR-T infusion according to the Lugano Classification (Cheson et al, 2014), as determined by study investigators.'}], 'secondaryOutcomes': [{'measure': 'Objective remission rate (ORR) in 3months', 'timeFrame': '3 months post CAR-T infusion', 'description': 'ORR in 3 moths is defined as the incidence of either a CR or a partial response (PR) within 3 months after CAR-T infusion per the Lugano Classification as determined by study investigators.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': '2 years post CAR-T infusion', 'description': 'OS is defined as the time from CAR-T infusion to the date of death from any cause.'}, {'measure': 'Adverse events (AEs)', 'timeFrame': '2 years post CAR-T infusion', 'description': 'Types, frequency, and severity of adverse events and laboratory anomalies Physiological parameter'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CAR-T'], 'conditions': ['Lymphoma, Non-Hodgkin']}, 'descriptionModule': {'briefSummary': "This study aims to collect clinical data from adult patients with relapsed or refractory non-Hodgkin's lymphoma (r/r NHL) receiving cellular immunotherapy to establish a large database of cellular immunotherapy for Chinese patients.", 'detailedDescription': 'This study aims to collect efficacy and safety data from adult patients with r/r NHL who received cellular immunotherapy between January 2017 and December 2040. Study investigators will determine the most appropriate diagnostic and treatment plans for patients based on clinical practice, without any intervention due to the existence of this study. No grouping will be conducted, and subgroup analyses will be performed based on the collected data.\n\nData collection process:\n\nClinical data will be collected from patients before cellular immunotherapy, before immune cell infusion, on the day of infusion, and at the last visit or follow-up within 24 months post-infusion. This includes collecting efficacy data, adverse events related to cellular immunotherapy, and survival data. Additionally, any new tumors, pathological findings, and other relevant laboratory or auxiliary examination data will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with relapsed or refractory lymphoma receiving cellular immunotherapy', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with a confirmed diagnosis of r/r B-NHL (including r/r DLBCL, r/r FL, r/r MCL, HGBL-NOS, FL3b, r/r MZL, transformed lymphomas such as MCL) and r/r T-cell lymphoma, who have received informed consent waivers;\n* Patients who have received or are receiving cellular immunotherapy, with cellular immunotherapy products including the following categories: cytokine-induced killer cell therapy (CIK), tumor-infiltrating lymphocytes (TIL), cytokine-induced killer cell-dendritic cell mixed therapy (DC-CIK), chimeric antigen receptor T cells, NK cells or macrophage therapy (CAR-T, CAR-NK, CAR-M), T-cell receptor chimeric T cell therapy (TCR-T), dendritic cell therapy.\n\nExclusion Criteria:\n\n* NA'}, 'identificationModule': {'nctId': 'NCT06541327', 'briefTitle': 'Cellular Immunotherapy for Relapsed or Refractory Lymphoma Data Collection', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Cellular Immunotherapy for Relapsed or Refractory Lymphoma Data Collection', 'orgStudyIdInfo': {'id': 'CCIC-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CAR-T', 'description': 'Chimeric antigen receptor modified T cells', 'interventionNames': ['Drug: Chimeric Antigen Receptor']}], 'interventions': [{'name': 'Chimeric Antigen Receptor', 'type': 'DRUG', 'otherNames': ['Chimeric antigen receptor modified T cells'], 'description': 'CAR-T', 'armGroupLabels': ['CAR-T']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zixun Yan', 'role': 'CONTACT', 'email': 'yzx12119@rjh.com.cn'}], 'facility': 'Department of Hematology, Shanghai Institute of Hematology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Weili Zhao', 'role': 'CONTACT', 'email': 'zwl_trial@163.com', 'phone': '+862164370045'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhao Weili', 'investigatorAffiliation': 'Ruijin Hospital'}}}}