The DESCAR-T registry was set up at the request of the health authorities to improve our knowledge of CAR T-cell therapies marketed 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.
Thanks to the data collected, the registry makes it possible to carry out projects to answer specific research questions. One of these projects is investigating the efficacy and safety of CAR-T cells received by patients with mantle cell lymphoma (MCL) with central nervous system (CNS) involvement.
Why is this study being implemented?
Central nervous system lymphomas (CNS NHL) represent a group of rare lymphomas affecting the brain, cerebrospinal fluid, eye and much more rarely the spinal cord. Clinically, a distinction is made between primary and secondary CNS NHL. The former are strictly limited to the CNS. The latter are defined by concomitant body and nervous system involvement or according to a previous involvement of the body before CNS localization.
The use of CAR-T cells has revolutionized the management of NHL, but it has been slow to affect CNS NHL. Lately, the efficacy of CAR T-cells has been described in these primary or secondary CNS NHLs, but this is almost exclusively in diffuse large B-cell non-Hodgkin lymphoma. The literature remains extremely limited regarding CNS-localized mantle cell lymphoma (MCLSNC).
A more precise description of MCLSNCs, a search for predictive factors of response, and the analysis of toxicities, especially neurotoxicities, seem necessary.
What are the objectives of the study?
The study first aims to describe the real-life efficacy of CAR T-cells in patients with MCLSNC. Its second objective is to describe the tolerance of these therapies and to identify possible prognostic factors, particularly at the neurological level.
If feasible, the previous objectives will be repeated by comparing with diffuse CNS NHL (ETCETERA study) and/or by investigating differences in response depending on the injected CAR T-cell product.
How will the study be carried out?
This study is led by Dr. GUIDEZ and Pr. ROOS-WEIL, respectively from the Poitiers and Pitié Salpêtrière (Paris) University Hospitals.
The study will be based on the analysis of data from the DESCAR-T registry. The analyses will be carried out by the project leaders.
This study will be carried out at the end of 2024 and the results are expected to be presented at international congresses on lymphoma and as a scientific article in 2025.
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 mantle-cell Lymphoma, for whom CAR T-cell therapy has been injected (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“.