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

Novartis

Status: Completed

Conditions: Acute Lymphoblastic Leukemia (ALL); Diffuse Large B-Cell Lymphoma (DLBCL)

Treatments: Other: KYMRIAH; Other: YESCARTA

Study type: Observational

Funder types: Industry

Identifiers

NCT05349201

CCTL019A0FR02

Details and patient eligibility

About

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

Full 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

Enrollment: 273 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients treated with CAR-T cells from 2017 to 2019 and informed as such in the PMSI And
• Patients diagnosed with ALL or DLBCL when administering CAR-T cells and
• up to 25 years for patients with ALL

Exclusion criteria

• All patients treated outside the two types of indications presented in the inclusion criteria will be excluded

Trial design

273 participants in 3 patient groups

Adult R/R DLBCL cohort: KYMRIAH

Description:

Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma \[R/R DLBCL\])

Treatment:

Other: KYMRIAH

Adult R/R DLBCL cohort: YESCARTA

Description:

Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma \[R/R DLBCL\])

Treatment:

Other: YESCARTA

ALL pediatric and young adult cohort: KYMRIAH

Description:

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

Treatment:

Other: KYMRIAH