Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT06785818
Status:
RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-term Follow up Local Registry Study of Kymriah in South Korea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002051', 'term': 'Burkitt Lymphoma'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'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': 'C000626284', 'term': 'tisagenlecleucel'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 179}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2039-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-01-15', 'studyFirstSubmitQcDate': '2025-01-15', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2039-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The type and frequency of AEs, ADRs, SAEs, SADRs, UAEs, UADRs, USAEs, USADRs, AESI', 'timeFrame': 'Up to 15 years post-infusion', 'description': 'The type and frequency of adverse event (AE)/adverse drug reaction (ADR)/ serious adverse event (SAE)/serious adverse drug reaction (SADR)/ unexpected adverse event (UAE)/unexpected adverse drug reaction (UADR)/ unexpected serious adverse event (USAE)/unexpected serious adverse drug reaction (USADR)/ adverse event of special interest (AESI)'}, {'measure': 'Identify participants for chimeric antigen receptor (CAR) transgene detection and/or CAR surface expression (if applicable).', 'timeFrame': 'Up to 15 years post-infusion', 'description': 'When applicable, identify patients for CAR transgene detection and/or CAR surface expression by quantitative polymerase chain reaction (q-PCR), in-situ hybridization, flow cytometry and/or immunohistochemistry (IHC), whichever testing is appropriate, in relevant samples (blood, bone marrow, etc.)'}, {'measure': 'Identify presence of replication competent lentivirus (RCL) in blood or tissues', 'timeFrame': 'Up to 15 years post-infusion', 'description': 'Replication competent lentiviruses (RCL) are virus particles capable of infecting cells and replicating to produce additional infectious particles.'}], 'secondaryOutcomes': [{'measure': 'B-Cell Acute Lymphoblastic Leukemia - Overall response rate (ORR)', 'timeFrame': 'Up to 15 years post-infusion', 'description': 'The overall response rate (ORR) is defined as the percentage of subjects with a best overall disease response of complete response (CR) or Complete remission with incomplete blood count recovery (CRi). For ALL (Acute Lymphoblastic Leukemia), complete remission is defined as: less than 5% blasts in marrow, less than 1% blasts in blood and no EM disease.'}, {'measure': 'B-Cell Acute Lymphoblastic Leukemia - Duration of response (DOR)', 'timeFrame': 'Up to 15 years post-infusion', 'description': 'Duration of Response (DoR) is defined as the time from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first.'}, {'measure': 'B-Cell Acute Lymphoblastic Leukemia - Relapse-free survival (RFS)', 'timeFrame': 'Up to 15 years post-infusion', 'description': 'RFS is defined as the time from the date of first dose of the study treatment to the date of the first documented disease recurrence or death due to any cause whichever comes first.'}, {'measure': 'B-Cell Acute Lymphoblastic Leukemia - Event-free survival (EFS)', 'timeFrame': 'Up to 15 years post-infusion', 'description': 'Event free survival is the time from the date of start of treatment to the earliest of the following:\n\n* Death from any cause after remission\n* Relapse\n* Treatment failure (failure to achieve remission, including death without remission)'}, {'measure': 'B-Cell Acute Lymphoblastic Leukemia - Proportion of patients with minimal residual disease (MRD) negative status in bone marrow who achieve a best overall response (BOR) of CR or CRi', 'timeFrame': 'Up to 15 years post-infusion', 'description': 'MRD is a term used to describe a very small number of cancer cells that remain in the body during or after treatment. MRD is defined as positive by immunophenotype if 1/1000 cells is positive.'}, {'measure': 'Diffuse Large B-Cell Lymphoma - Overall response rate (ORR)', 'timeFrame': 'Up to 15 years post-infusion', 'description': 'The overall response rate (ORR) is defined as the percentage of subjects with a best overall disease response of complete response (CR) or Partial response (PR)'}, {'measure': 'Diffuse Large B-Cell Lymphoma - DOR', 'timeFrame': 'Up to 15 years post-infusion', 'description': 'Duration of Response (DoR) is defined as the time from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first.'}, {'measure': 'Diffuse Large B-Cell Lymphoma - RFS', 'timeFrame': 'Up to 15 years post-infusion', 'description': 'RFS is defined as the time from the date of first dose of the study treatment to the date of the first documented disease recurrence or death due to any cause whichever comes first.'}, {'measure': 'Diffuse Large B-Cell Lymphoma - Progression-free survival (PFS)', 'timeFrame': 'Up to 15 years post-infusion', 'description': 'Progression-free survival is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause whichever comes first.'}, {'measure': 'Diffuse Large B-Cell Lymphoma - Overall survival (OS)', 'timeFrame': 'Up to 15 years post-infusion', 'description': 'Overall survival is the time from date of start of treatment to the date of death due to any reason.'}, {'measure': 'Follicular Lymphoma - ORR', 'timeFrame': 'Up to 15 years post-infusion', 'description': 'The overall response rate (ORR) is defined as the percentage of subjects with a best overall disease response of complete response (CR) or Partial response (PR)'}, {'measure': 'Follicular Lymphoma -Complete response rate (CRR)', 'timeFrame': 'Up to 15 years post-infusion', 'description': 'Complete response rate is the proportion of patients with a complete disease response, which is defined as the best disease response recorded from date of start of treatment until progressive disease or start of new anticancer therapy, whichever comes first.'}, {'measure': 'Follicular Lymphoma - DOR', 'timeFrame': 'Up to 15 years post-infusion', 'description': 'Duration of Response (DoR) is defined as the time from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first.'}, {'measure': 'Follicular Lymphoma - RFS', 'timeFrame': 'Up to 15 years post-infusion', 'description': 'RFS is defined as the time from the date of first dose of the study treatment to the date of the first documented disease recurrence or death due to any cause whichever comes first.'}, {'measure': 'Follicular Lymphoma - PFS', 'timeFrame': 'Up to 15 years post-infusion', 'description': 'Progression-free survival is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause whichever comes first.'}, {'measure': 'Follicular Lymphoma - Overall survival (OS)', 'timeFrame': 'Up to 15 years post-infusion', 'description': 'Overall survival is the time from date of start of treatment to the date of death due to any reason.'}, {'measure': 'Frequency and rate of pregnancy outcomes', 'timeFrame': 'Up to 15 years post-infusion', 'description': 'pregnancy outcomes:\n\n* Live birth, at term (presence or absence of congenital abnormality)\n* Live birth, premature (presence or absence of congenital abnormality)\n* Intrauterine fetal death\n* Spontaneous abortion\n* Elective abortion\n* Unknown'}]}, 'conditionsModule': {'keywords': ['B-Lymphocyte Malignancies', 'B-ALL', 'DLBCL', 'FL', 'Tisagenlecleucel', 'South Korea'], 'conditions': ['B-Cell Acute Lymphoblastic Leukemia, Diffuse Large B-Cell Lymphoma, Follicular Lymphoma']}, 'descriptionModule': {'briefSummary': 'This study is multicenter, primary data collection, non-interventional registry study to assess long-term safety, secondary malignancy risk, and effectiveness of tisagenlecleucel in patients with B-cell malignancies in a routine clinical practice setting in Korea.', 'detailedDescription': 'This study will inform on long-term real-world safety and effectiveness of tisagenlecleucel. The primary objective is to evaluate the long-term safety and the risk of secondary malignancies in patients with B lymphocyte malignancies treated with tisagenlecleucel in a real-world setting. The main secondary objective is to evaluate the longterm effectiveness of tisagenlecleucel.\n\nAll participants enrolled in this study will be followed up for 15 years from the time of Kymriah® infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with B-Lymphocyte Malignancies Treated with Tisagenlecleucel in South Korea', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who receive tisagenlecleucel infusion in the commercial setting, treated under a managed access program or other pathway, e.g., when product was manufactured for the commercial setting but turned out to be out of specification (OOS).\n2. Consented to data collection.\n\nExclusion Criteria:\n\n1\\. Patients who are enrolled or will be enrolled in the Novartis long term follow-up protocol CCTL019A2205B.'}, 'identificationModule': {'nctId': 'NCT06785818', 'briefTitle': 'Long-term Follow up Local Registry Study of Kymriah in South Korea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Registry to Assess Long-Term Safety of Patients With B-Lymphocyte Malignancies Treated With Tisagenlecleucel in South Korea', 'orgStudyIdInfo': {'id': 'CCTL019CKR02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tisagenlecleucel', 'description': 'Patients who have been treated with tisagenlecleucel', 'interventionNames': ['Other: Tisagenlecleucel']}], 'interventions': [{'name': 'Tisagenlecleucel', 'type': 'OTHER', 'otherNames': ['Kymriah®'], 'description': 'This is an observational study. There is no treatment allocation. The decision to initiate tisagenlecleucel will be based solely on clinical judgement.', 'armGroupLabels': ['Tisagenlecleucel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Bundang Gu', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Novartis Investigative Site'}, {'zip': '463-712', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '10408', 'city': 'Gyeonggi-do', 'state': 'Korea', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '405 760', 'city': 'Incheon', 'state': 'Korea', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '02841', 'city': 'Seoul', 'state': 'Korea', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03080', 'city': 'Seoul', 'state': 'Korea', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08308', 'city': 'Seoul', 'state': 'Korea', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'state': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '49201', 'city': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '04401', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06591', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Novartis Pharmaceuticals', 'role': 'CONTACT', 'email': 'novartis.email@novartis.com', 'phone': '+41613241111'}, {'name': 'Novartis Pharmaceuticals', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}