Spots Global Cancer Trial Database for CAR T Cells Real World Evidence Study Based on the French Hospital Claims Data Source (PMSI)
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Trial Identification
Brief Title: CAR T Cells Real World Evidence Study Based on the French Hospital Claims Data Source (PMSI)
Official Title: CAR-T Cells - Real Life Study Of Care Pathway And Total Cost Of Care For Patients Under Car T-Cell Treatment Based On The PMSI French Database
Study ID: NCT05349201
Study Description
Brief Summary: This was a Retrospective cohort study based on the PMSI data source
Detailed Description: A retrospective database analysis was performed using the French national hospital claims database (Medicalized Information System Program - PMSI, 2015-2019), which includes discharge summaries for all hospital admissions in France (\~99% of French residents). The patients were identified based on the CAR-T administration hospital stay, between 2017 and 2019. Based on the exhaustivity of the database, all patients treated with CAR-T (since 2018) were identified. The study design included multiple periods of analysis based on the CAR-T process. Three main periods were defined: the historical period, the CAR-T period, and the post CAR-T period. The CAR-T period was divided in 2 sub-periods: pre CAR-T (including the apheresis procedure and 15 days before this procedure) and per CAR-T (including the lymphodepletion and CAR-T cell injection hospital stay until the end at the discharge date related to CAR-T cell injection hospital stay). The follow-up period started at the end of CAR-T hospital stay. CAR-T populations: KYMRIAH® DLBCL cohort: * Adult patients (≥18 years of age) with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. * Patient with a CAR-T administration hospital stay of Kymriah between 2017 and 2019 YESCARTA®DLBCL cohort: * Adult patients (≥18 years of age) with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy: * Patient with a CAR-T administration hospital stay of Yescarta between 2017 and 2019 KYMRIAH® ALL cohort: * Pediatric and young adult patients (≤ 25 years of age) with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse: * Patient with a CAR-T administration hospital stay of Kymriah between 2017 and 2019
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Novartis Investigative Site, East Hanover, New Jersey, United States
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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