The DESCAR-T registry was set up at the request of the health authorities to improve knowledge of CAR T-cell therapies made available in France to treat patients diagnosed with hematological malignancies. The objective of this registry is to collect data on the efficacy as well as on short- and long-term tolerance of these therapies in real-life setting.
Using the registry data, research projects to answer specific questions can be undertaken. One of these projects aims to better understand the profile of patients in intent-to-treat with CAR T-cells and the efficacy and safety of these therapies in patients diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL) after at least two previous lines of cancer therapy.
Why is this study being implemented?
The biopharmaceutical company Bristol Myers Squibb (BMS) develops and markets CAR T-cells therapies, indicated for the treatment of several hematological malignancies such as lymphoma and multiple myeloma.
In 2021, BMS contacted LYSARC to conduct an analysis based on the data collected in the DESCAR-T registry in order to prepare the arrival on the market of their own CAR-T. The objective was to better understand the profile of patients diagnosed with B-cell lymphoma treated with CAR-T already marketed at the time, as well as to better understand the efficacy and safety of these new therapies in real life (without information on the type of CAR-T received). Analyses for this project were performed in 2021 on data from patients treated in France with CAR T-cells for B-cell lymphoma and included in the registry before April 12th, 2021.
In 2023, BMS contacted LYSARC to update this analysis on patients with Relapsed/Refractory Large B-Cell Lymphoma (RR LBCL), Follicular Lymphoma (FL), or Mantle Cell Lymphoma (MCL) treated with (or intended to receive) CAR T therapies approved to date in France.
The DESCAR-T registry collects data from the medical records of patients who are offered CAR-T in France, whether they ultimately receive it or not. These data help understand the profile of these patients and the characteristics of their lymphoma. The registry also allows evaluating the real-life efficacy and safety of CAR T-cell therapies and provides important information on the best use to make of these treatments.
What are the objectives of the study?
Firstly, the study aims to describe the profile and treatment patterns of patients with RR LBCL, FL, or MCL treated with (or intended to receive) CAR T therapies in real world setting in France over time.
Secondly, it will describe the efficacy and safety of these therapies in patients with RR LBCL who ultimately receive CAR T-cells after two previous lines of treatment.
Although RR LBCL patients in the registry have previously been described, this study will provide updated outcomes in a larger sample size.
This study will provide the pharmaceutical company with important information on the use of the therapy and will help to clarify the unmet medical need for lymphoma patients.
How will the study be carried out?
This will be a nationwide observational study of patients with RR LBCL, FL, or MCL treated with (or intended to receive) CAR T therapies in the real-world setting in France.
The study will be carried out using data from the DESCAR-T registry. These analyses will be done by LYSARC.
A study report will be sent to BMS, who will only receive a report of aggregated results (no individual data). No link can be made between the information in the report and the patients whose data is collected in DESCAR-T.
FOR PATIENTS WHO HAVE BEEN OFFERED CAR-T THERAPY IN FRANCE
What does this project mean for you?
This project concerns patients included in the DESCAR-T registry, diagnosed with Diffuse Large B-Cell Lymphoma, Follicular Lymphoma or Mantle Cell Lymphoma for whom CAR T-cell therapy has been considered (outside clinical trials) in France.
If you are in this situation and agree for your data to be used for this project, this has no direct implications for you.
What should you do about this study?
– If you would like more information about the processing of your data in the context of DESCAR-T and this project,
Or
– If you wish to exercise your rights regarding your data (access and rectification, limitation of their use),
⇒ inform the doctor at your hospital or centre of care for CAR T-cell therapy, who will contact LYSARC while maintaining your anonymity. You can also notify your decision by email at: dpo@lysarc.org.
– Otherwise, you don’t have to do anything.
You can find more information about your rights in relation to your data “I am participating or have participated in a trial“.