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 focuses on the profile of patients over 75 years of age (pts ≥ 75 years old) diagnosed with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) treated with CAR-T and the efficacy and safety of these treatments in these patients after at least two previous lines of lymphoma treatment.
Why is this analysis 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 are not sufficiently effective for some patients. Either the disease progress despite the treatment (it is then considered “refractory”), or it relapses after a period of remission.
Anti-CD19 CAR-T cell therapies have revolutionized the management of relapsed or refractory Diffuse Large cell B-Cell Lymphoma (R/R LDBCL), providing a new curative treatment option in a situation where few treatments work. In subjects aged 75 years or older, there are few data, either in terms of efficacy (in particular due to the aging of the immune system called immunosenescence) or tolerance (i.e. the ability to withstand the adverse effects of treatments, in more fragile patients) because this population was not present in clinical trials.
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. The aim of this project is therefore to provide the medical and scientific community with original elements of knowledge concerning the effectiveness and tolerance of CAR-T cell therapies in patients aged 75 or over suffering from DLBCL.
What are the objectives of the analysis?
Firstly, the study aims to explore outcomes of R/R DLBCL in patients aged 75 years or older treated in 3rd line or higher with anti-CD19 CAR-T.
Its secondary objectives are, on one hand, to compare the results with those of patients under 75 years of age (pts < 75 years of age), and, on the other hand, to compare the results of the 2 different anti-CD19 CAR-T cells available (axi-cel and tisa-cel) in the population of 75 years of age or older.
How will the analysis be carried out?
This project is led by Dr. Blandine Guffroy of ICANS (Strasbourg Europe Cancer Institute) and Dr. Pierre Bories of IUCT-Oncopole (University Cancer Institute of Toulouse). The study is based on the analysis of data from the DESCAR-T registry. The analyses are carried out by LYSARC team. The report of this study will be sent to the project leaders, who will only receive 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.
This study was the subject of a series of analyses between January and July 2024. Initial results were presented orally at the European Hematology Association (EHA) congress in June 2024 and new results are expected to be reported at the American Society of Hematology (ASH) International Congress in December 2024. This work should then be the subject of a scientific publication in a medical research journal in 2025.
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 Diffuse Large B-Cell Lymphoma, for whom CAR T-cell therapy has been considered (outside clinical trials) 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“