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 aims to better understand the efficacy and safety of CAR T-cells for patients living with HIV and diagnosed with B-Cell Lymphoma (BCL) after at least one previous line of cancer therapy.
Why is this analysis being implemented?
CAR T-cells are innovative therapies that have been offered for more than five years to some patients with relapsed or refractory BCL. Clinical trials that have led to the commercialization of CAR-T cells do not include patients with the AIDS virus. It seems necessary and appropriate to study these therapies in this specific population in real life using data from the DESCAR-T registry.
What are the objectives of the analysis?
Firstly, this study aims to describe the efficacy and safety in real life of CAR-T cells in patients living with HIV and diagnosed with BCL.
Its second objective is to study immune reconstruction and the evolution of HIV infection following an infusion of CAR-T.
How will the analysis be carried out?
This project is led by Dr. Roberta Di Blasi and Dr. Michele Clerico of the Saint-Louis Hospital of the Assistance Publique des Hôpitaux de Paris.
The study will be carried out using data from the DESCAR-T registry and with additional data collected from French hospitals by the project leaders. The analyses of the additional data will be carried out by the project leaders. The analyses of the DESCAR-T data will be carried out by LYSARC. The report of this study will be sent to the project leaders, who will only receive a report of aggregated results without individual data. No link can be made between the information contained in the report and the patients whose data is collected in DESCAR-T.
This study will be conducted in June and July 2024 and the results are expected to be reported at 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 B-Cell Lymphoma, for whom CAR T-cell therapy has been considered (outside clinical trials) in France after at least one other line 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“