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

Acute Lymphoblastic Leukemia (ALL) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05349201
• Other study ID #: CCTL019A0FR02
• Status: Completed
• Start date: December 9, 2020
• Est. completion date: May 28, 2021

Study information

• Verified date: June 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: May 28, 2021
• Est. primary completion date: May 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• KYMRIAH
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
• YESCARTA
Patients (=18 years of age) with (relapsed/refractory diffuse large B cell lymphoma [R/R DLBCL])

Locations

Country	Name	City	State
United States	Novartis Investigative Site	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)

External Links

•   Results for CCTL019A0FR02 from the Novartis Clinical Trials Results Database