Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT06271369
Status:
COMPLETED
Last Update Posted:
2024-02-21
First Post:
2024-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real-World HRU and Costs in DLBCL Pts With Tisa-cel and Axi-cel, a Medicare 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 613}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-14', 'studyFirstSubmitDate': '2024-02-14', 'studyFirstSubmitQcDate': '2024-02-14', 'lastUpdatePostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with IP admission', 'timeFrame': 'Up to approximately 6 years'}, {'measure': 'Number of IP admissions', 'timeFrame': 'Up to approximately 6 years'}, {'measure': 'IP days', 'timeFrame': 'Up to approximately 6 years', 'description': 'Described as the cumulative number of days during IP stays including ICU.'}, {'measure': 'Number of ICU stays', 'timeFrame': 'Up to approximately 6 years', 'description': 'Described as the cumulative number of days during ICU stays.'}, {'measure': 'ICU days', 'timeFrame': 'Up to approximately 6 years'}, {'measure': 'Number of patients with OP visit', 'timeFrame': 'Up to approximately 6 years', 'description': 'OP services include office visits, skilled-nursing facility, home care, durable medical equipment, and other services that are not included in IP stays or ER visits.'}, {'measure': 'Number of OP visits', 'timeFrame': 'Up to approximately 6 years'}, {'measure': 'Number of patients with ER visit', 'timeFrame': 'Up to approximately 6 years'}, {'measure': 'Number of ER visits', 'timeFrame': 'Up to approximately 6 years'}, {'measure': 'Healthcare reimbursement costs', 'timeFrame': 'Up to approximately 6 years', 'description': 'Healthcare reimbursement costs were defined as the amount paid by Medicare to the provider for medical services.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Up to approximately 6 years', 'description': 'OS was defined as the time from administration of CAR-T therapy to death due to any cause.'}, {'measure': 'Time to next treatment (TTNT) or death', 'timeFrame': 'Up to approximately 6 years', 'description': 'TTNT was defined as the time from administration of CAR-T therapy to the initiation of the next line of treatment or death due to any cause.'}]}, 'conditionsModule': {'conditions': ['Diffuse Large B-cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'This was a retrospective non-interventional cohort study design using the Centers for Medicare and Medicaid Services (CMS) 100% Medicare data (2015Q1-2020Q4).\n\nEligible adult patients with r/r DLBCL who were treated with CAR-T therapy were identified from the CMS 100% Medicare data. Patients who received chimeric antigen receptor modified T cell (CAR-T) therapy were further classified into tisa-cel and axi-cel cohorts based on the type of CAR-T treatment received. The index date was defined as the date of tisa-cel or axi-cel therapy administration. Baseline period was defined as three months prior to the index date. Study period was defined from the index date to the end of health plan coverage based on insurance enrollment file or death, whichever occurred earlier.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This was a retrospective, noninterventional cohort study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients had at least one International Classification of Diseases, 10th Revision (ICD-10) diagnosis code for DLBCL.\n* Patients received CAR-T therapy, including both tisa-cel and axi-cel, following DLBCL diagnosis. The administration date of CAR-T therapy was defined as the index date.\n* Patients were at least 18 years of age as of the index date.\n* Patients had at least three months of continuous health plan enrollment before the index date.\n\nExclusion Criteria:\n\n* Patients who had a medical claim associated with a clinical trial within one month before and after the index date.\n* Patients who had zero cost on index date for CAR-T infusion.'}, 'identificationModule': {'nctId': 'NCT06271369', 'briefTitle': 'Real-World HRU and Costs in DLBCL Pts With Tisa-cel and Axi-cel, a Medicare Study.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Real-world Study Comparing Tisagenlecleucel (Tisa-cel) With Axicabtagene Ciloleucel (Axi-cel) on Healthcare Resource Use (HRU), Costs, and Overall Survival (OS) in Diffuse Large B-cell Lymphoma (DLBCL): A Retrospective Study of Medicare Population', 'orgStudyIdInfo': {'id': 'CCTL019CUS13'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tisa-cel cohort', 'description': 'Patients with at least one ICD-10 diagnosis for DLBCL who were at least 18 years old. Patients also had at least three months of continuous health plan enrollment before administration of CAR-T therapy and received tisa-cel following DLBCL diagnosis.'}, {'label': 'Axi-cel cohort', 'description': 'Patients with at least one ICD-10 diagnosis for DLBCL who were at least 18 years old. Patients also had at least three months of continuous health plan enrollment before administration of CAR-T therapy and received axi-cel following DLBCL diagnosis.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07936', 'city': 'East Hanover', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis', 'geoPoint': {'lat': 40.8201, 'lon': -74.36487}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}