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

Acute Lymphoblastic Leukemia (ALL) Clinical Trial

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

Status Completed

Clinical Trial Summary

This was a Retrospective cohort study based on the PMSI data source

Clinical Trial 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 ;

Related Conditions & MeSH terms

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

• NCT number: NCT05349201
• Study type: Observational
• Source: Novartis
• Status: Completed
• Start date: December 9, 2020
• Completion date: May 28, 2021