Clinical trial NCT05349201: CAR T Cells Real World Evidence Study Based on the French Hospital Claims Data Source (PMSI)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diffuse Large B-Cell Lymphoma (DLBCL)
Acute Lymphoblastic Leukemia (ALL)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-04-27
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
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

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

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival: number of events
timeFrame: through study completion, approximately 2 years (January 2017 to December 2019)
measure: Time to next treatment (TTNT) analysis: number of events
timeFrame: through study completion, approximately 2 years (January 2017 to December 2019)
measure: Time to next treatment (TTNT) or death analysis: number of events
timeFrame: through study completion, approximately 2 years (January 2017 to December 2019)
measure: Follow-up time between the CAR-T injection and the last hospital stay observed
timeFrame: through study completion, approximately 2 years (January 2017 to December 2019)
measure: Overall cost for CAR-T hospitalization
timeFrame: through study completion, approximately 2 years (January 2017 to December 2019)
Secondary outcomes:
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Investigative Site
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: