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 profile of patients in intent-to-treat with CAR T-cells and the efficacy and safety of these therapies in patients diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL) after at least two previous lines of cancer therapy.
Why is this analysis being implemented?
Certain subtypes of large B-cell lymphoma (LBCL) such as high-grade B-cell lymphoma (HGBL), double hit, triple hit and not otherwise specified (NOS), are considered particularly aggressive diseases. Standard chemotherapy like R-CHOP is not always enough. These patients experience high rates of early relapse. CAR-T cell therapy has changed the therapeutic landscape of LBCL in chemo-resistant LBCL in 3rd line, and more recently in 2nd line of treatment. The prognosis with CAR-T appears to be as good in HGBL as in other LBCL subtypes. However, no studies investigating the impact of CAR-T cells in patients with HGBL, especially in a real-world setting, are available so far.
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 and provides important information on the best use to make of these treatments among current and future therapeutic options.
What are the objectives of the analysis?
The study aims to compare the prognosis of a large cohort of patients with HGBL versus other LBCL subtypes in a real-world context, based on the French DESCAR-T registry.
How will the analysis be carried out?
This project is led by Dr. Louise Roulin and Xavier Phina-Ziebin (medical intern), from the Henri Mondor Hospital of the Assistance Publique des Hôpitaux de Paris.
The study is based on the analysis of data from the DESCAR-T registry and additional work to validate the medical diagnoses of patients by the project leaders. The statistical analyses will be carried out by the LYSARC team. The statistical 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 carried out in 2023 and the results were communicated through a poster at the American Society of Hematology (ASH) International Congress in December 2023 and are expected to be published in a medical research journal at the end of 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 high-grade B-cell lymphoma (HGBL), 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“