The DESCAR-T registry was set up at the request of the health authorities to improve our knowledge of Chimeric antigen receptor T-cell (CAR T-cell) therapies 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 describe outcomes and salvages strategies for patients with relapsed or refractory mantle cell lymphoma (MCL) after CAR-T infusion.
Why is this analysis being implemented?
Mantle cell lymphoma (MCL) is a subtype of B-cell non-Hodgkin’s lymphoma (NHL) with a heterogeneous clinical course, generally aggressive.
Brexucabtagene autoleucel (brexu-cel) is a CAR-T-cell approved since 2020 for the treatment of patients with relapsed or refractory mantle cell lymphoma after at least two lines of treatment.
However, recent real-life studies have shown that in some patients, this treatment is not effective enough. Either the disease progress despite the treatment (it is then considered “refractory”), or it relapses after a period of remission. Outcomes for these patients relapsing post brexu-cel treatment remain largely unexplored.
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 among current and future therapeutic options.
This study aims to describe the profile of patients with mantle cell lymphoma who relapsed after treatment with brexu-cel, the strategies for treating relapse (salvages strategies) and their outcome.
What are the objectives of the analysis?
Firstly, the study aims to describe the profile and treatment patterns of patients with relapsed or refractory mantle cell lymphoma treated with brexu-cel therapy after two previous lines of treatment in real world setting in France.
Secondly, it aims to identify prognostic factors and treatment options after CAR-T for these patients.
This study will identify alternative therapeutic strategies to improve the management of patients with relapsed or refractory mantle cell lymphoma after CAR-T cell failure and will help clarify the unmet medical needs for these patients.
How will the analysis be carried out?
The study will be carried out using data from the DESCAR-T registry. These analyses will be done by members of LYSARC.
A study report will be sent to the academic project leader, Dr. Clémentine Sarkozy, hematologist at Institut Gustave Roussy (Villejuif, France), 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.
This study will be carried out in June and July 2024 and the results will be communicated to the American Society of Hematology (ASH) International Congress in December 2024.
FOR PATIENTS WHO HAVE RECEIVED CAR-T THERAPY IN FRANCE
What does this project mean for you?
This project concerns patients included in the DESCAR-T registry, diagnosed with Mantle Cell Lymphoma, and who received a CAR T-cell therapy (brexu-cel) in France after two other lines of treatment for this disease.
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 study,
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“