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.
Why is this study being implemented?
Diffuse Large B-Cell Lymphoma is the most common type of non-Hodgkin lymphoma. Current treatments can cure most patients. However, these treatments may not be effective enough for some patients. Either the disease progress despite the treatment (it is then considered “refractory”), or it relapses after a period of remission. The number of treatment lines following relapse varies from patient to patient.
The advent of CAR-T cell treatments has opened up new perspectives on the treatment of the disease. One of these CAR-T therapies called axicabtagene ciloleucel (axi-cel) has been shown to be more effective than standard immunochemotherapy as a second-line (2L) treatment in patients with relapsed or refractory (R/R) LBCL.
What are the objectives of the study?
The objective of this analysis was to describe for the first time the patient characteristics, care pathway and outcomes of all patients included in the DESCAR-T registry since July 2022, to receive axi-cel in accordance with the early access program supported by the French authorities for patients with LBCL in early relapse (< 1 year) or refractory after a first line of treatment.
How will the study be carried out?
This study is carried out by Dr. HOUOT of the Ponchaillou University Hospital in Rennes and Dr. LE GOUILL of the Hotel Dieu University Hospital in Nantes.
The analysis of the data from the DESCAR-T registry was carried out by the LYSARC teams in 2023. The report of this study was sent to the project leaders who only received descriptive results without individual data. No link can be established between the data contained in the report and the patients whose data is collected in DESCAR-T because they are 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 have been presented at conferences and will be used to write scientific publications.
FOR PATIENTS WHO HAVE BEEN OFFERED CAR-T THERAPY IN FRANCE
What should you do about this study?
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 center 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“