CAR T Cells Real World Evidence Study Based on the French Hospital Claims Data Source (PMSI)
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)Acute Lymphoblastic Leukemia (ALL)
- Interventions
- Other: KYMRIAHOther: YESCARTA
- Registration Number
- NCT05349201
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 273
- 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
- All patients treated outside the two types of indications presented in the inclusion criteria will be excluded
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Adult R/R DLBCL cohort: KYMRIAH KYMRIAH Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma \[R/R DLBCL\]) Adult R/R DLBCL cohort: YESCARTA YESCARTA Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma \[R/R DLBCL\]) ALL pediatric and young adult cohort: KYMRIAH KYMRIAH 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
- Primary Outcome Measures
Name Time Method Time to next treatment (TTNT) or death analysis: number of events through study completion, approximately 2 years (January 2017 to December 2019) 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.
Overall survival: number of events through study completion, approximately 2 years (January 2017 to December 2019) 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).
Time to next treatment (TTNT) analysis: number of events through study completion, approximately 2 years (January 2017 to December 2019) Time to next treatment indicator was defined as the time between CAR-T injection and the date of the hospitalization or palliative care.
Overall cost for CAR-T hospitalization through study completion, approximately 2 years (January 2017 to December 2019) 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
Follow-up time between the CAR-T injection and the last hospital stay observed through study completion, approximately 2 years (January 2017 to December 2019) Follow-up is the time between the CAR-T injection (index date) and the last hospital stay observed.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Novartis Investigative Site
🇺🇸East Hanover, New Jersey, United States