Skip to main content
OpenTrials
Completed

NCT Number: NCT05349201

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL) Acute Lymphoblastic Leukemia (ALL) Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site

East Hanover, New Jersey, 07936-1080, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KYMRIAH

Other

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

Other

Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma [R/R DLBCL])

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 27, 2022
Registry last updated
Jul 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.