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

Study Overview
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Brief Summary
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This was a Retrospective cohort study based on the PMSI data source

Detailed Description
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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

Official Title
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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

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

Intervention / Treatment
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* Other: KYMRIAH
* Other: YESCARTA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult R/R DLBCL cohort: KYMRIAH<br>Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma [R/R DLBCL]) | Other: KYMRIAH<br>* 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<br>|
| Adult R/R DLBCL cohort: YESCARTA<br>Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma [R/R DLBCL]) | Other: YESCARTA<br>* Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma [R/R DLBCL])<br>|
| ALL pediatric and young adult cohort: KYMRIAH<br>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: KYMRIAH<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival: number of events | Overall survival indicator was defined as all cause death recorded at the hospital (MSO, HAD, SSR). Patients were censored at the date of last hospitalization observed (MSO/HAD/SSR/ACE). | through study completion, approximately 2 years (January 2017 to December 2019) | 
| Time to next treatment (TTNT) analysis: number of events | Time to next treatment indicator was defined as the time between CAR-T injection and the date of the hospitalization or palliative care. | through study completion, approximately 2 years (January 2017 to December 2019) | 
| Time to next treatment (TTNT) or death analysis: number of events | Time to next treatment or death indicator was defined as the first event occurring between TNTT or death presented during the hospitalization or palliative care. | through study completion, approximately 2 years (January 2017 to December 2019) | 
| Follow-up time between the CAR-T injection and the last hospital stay observed | Follow-up is the time between the CAR-T injection (index date) and the last hospital stay observed. | through study completion, approximately 2 years (January 2017 to December 2019) | 
| Overall cost for CAR-T hospitalization | The CAR-T hospitalization included Medical, Surgical, Obstetrics (MSO) hospitalization tariff and extra tariff linked to CAR-T treatment reimbursed by the health care insurance | through study completion, approximately 2 years (January 2017 to December 2019) |