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.
Using the registry data, research projects to answer specific questions can be undertaken. One of these projects focuses on the occurrence of secondary cancers such as T-cell malignancies after CAR T-cell therapy.
Why is this study being implemented?
CAR T-cells are innovative therapies that have been offered for more than five years now to certain patients with relapsed or refractory hemopathies such as B-cell lymphoma, multiple myeloma or acute B-lymphoblastic leukemia. However, rare cases of secondary cancers, such as T-cell malignancies, occurring after CAR-T treatment have been reported in the literature and by U.S. public health authorities. The real incidence of these T-cell malignancies and the responsibility of CAR T-cells in their occurrence is therefore an important public health issue.
The DESCAR-T registry, which collects data from all patients treated with CAR-T in France, will make it possible to calculate this incidence and thus better assess the risk of developing T-cell malignancies after CAR T-cell therapy.
What are the objectives of the study?
The study aims to investigate the incidence of T-cell malignancies following commercial CAR-T therapy in patients with B-cell lymphoma, multiple myeloma, or B-cell acute leukemia.
How will the study be carried out?
This study is carried out by Prof. Roch HOUOT of the Pontchaillou Hospital in Rennes and Dr. Rémy DULERY of the Saint-Antoine Hospital in Paris. They will have access to data from all patients participating in the DESCAR-T study. This data will not make it possible to establish a link with the identity of the patients because it is pseudonymised: the first and last names of each person are replaced by a unique number assigned when they are included in DESCAR-T. LYSARC and its partners cannot link this number to a patient’s identity.
The results of this study will be published in a scientific journal.
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, 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“.