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

June 29, 2022 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

273

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • East Hanover, New Jersey, United States, 07936-1080
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult R/R DLBCL cohort: KYMRIAH
Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma [R/R DLBCL])
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
Adult R/R DLBCL cohort: YESCARTA
Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma [R/R DLBCL])
Other: YESCARTA
Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma [R/R DLBCL])
ALL pediatric and young adult cohort: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival: number of events
Time Frame: 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).
through study completion, approximately 2 years (January 2017 to December 2019)
Time to next treatment (TTNT) analysis: number of events
Time Frame: 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.
through study completion, approximately 2 years (January 2017 to December 2019)
Time to next treatment (TTNT) or death analysis: number of events
Time Frame: 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.
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
Time Frame: 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.
through study completion, approximately 2 years (January 2017 to December 2019)
Overall cost for CAR-T hospitalization
Time Frame: 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
through study completion, approximately 2 years (January 2017 to December 2019)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 9, 2020

Primary Completion (ACTUAL)

May 28, 2021

Study Completion (ACTUAL)

May 28, 2021

Study Registration Dates

First Submitted

April 6, 2022

First Submitted That Met QC Criteria

April 21, 2022

First Posted (ACTUAL)

April 27, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 1, 2022

Last Update Submitted That Met QC Criteria

June 29, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCTL019A0FR02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Lymphoblastic Leukemia (ALL)

Clinical Trials on KYMRIAH

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe