CAR T Cells Real World Evidence Study Based on the French Hospital Claims Data Source (PMSI)
Condition: Diffuse Large B-Cell Lymphoma (DLBCL); Acute Lymphoblastic Leukemia (ALL)
MeSH terms: Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Large B-Cell, Diffuse
Study type: Observational

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
    

Intervention name(s): KYMRIAH; YESCARTA
Intervention type(s): Other; Other
Intervention description(s): 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; Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma [R/R DLBCL])
Intervention MeSH terms: Axicabtagene ciloleucel
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients ( ≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma [R/R
        DLBCL]), currently being treated in third line or more with

          -  KYMRIAH

          -  YESCARTA

        Pediatric and young adult patients (≤25 years of age) with B cell acute lymphoblastic
        leukemia ( refractory, in relapse post transplant or in second or later relapse, currently
        being treated in third line or higher with

        • KYMRIAH