NCT05349201

CAR T Cells Real World Evidence Study Based on the French Hospital Claims Data Source (PMSI)

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 273 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Not accepted

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

Conditions

• Diffuse Large B-Cell Lymphoma (DLBCL)
• Acute Lymphoblastic Leukemia (ALL)

Interventions

Type	Name	Description
OTHER	KYMRIAH	Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma \[R/R DLBCL\]) or Pediatric and young adult patients (≤25 years of age) with B cell acute lymphoblastic leukemia (ALL) refractory, in relapse post transplant or in second or later relapse
OTHER	YESCARTA	Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma \[R/R DLBCL\])

Timeline

• Start date: 2020-12-09
• Primary completion: 2021-05-28
• Completion: 2021-05-28
• First posted: 2022-04-27
• Last updated: 2022-07-01

Locations

1 site across 1 country: United States