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 collected data, the registry makes it possible to carry out projects to answer specific research questions. One of these projects focuses on lymphoma patients treated with CAR-T and for whom PET (Positron Emission Tomography) imaging was performed, before and after CAR-T injection.
Different kinds of lymphoma are part of this study: Diffuse Large B-Cell Lymphoma (DLBCL) (from the second line of treatment, i.e. after the first relapse of the disease), follicular lymphoma and mantle cell lymphoma. Only patients from the following hospitals participate in this project: Lyon Sud University Hospital, Rennes University Hospital, Montpellier University Hospital, Nice University Hospital, IPC Marseille, Lille University Hospital, Dijon University Hospital, Nantes University Hospital, Necker Hospital, Cochin Hospital, St Louis Hospital, Henri Mondor University Hospital and IUC Toulouse.
Why is this study being implemented?
18F-FDG Positron Emission Tomography (PET) is a metabolic imaging technique that has demonstrated its interest in the management of lymphoma. Therefore, it is important to evaluate the interest of PET in the context of new expensive therapies and more particularly CAR-T cells. In this context, a standardization of the evaluation of PET must be carried out, in particular to define the prognostic biomarkers and the interpretation criteria at diagnosis and at the different stages of therapeutic evaluation.
Therefor, LYSA has set up a working group on the interest of PET scans in patients treated with CAR-T cells. This group is composed of nuclear physicians from the LYSA-IM group.
What are the objectives of the study?
The objective is to build a database of PET images that are reviewed centrally by a panel of specialists and so for which the interpretation is standardized. These data could help answer questions about the role of PET in the management of lymphoma patients, by comparing the patient’s condition before CAR-T injection to the various examinations and follow-ups performed post-CAR-T.
The variables obtained from centralized review make it possible to establish this profile (TMTV -total tumor metabolic volume; SUV -nuclear quantification metric; measurement of the spleen; visual criteria on the bone marrow; score of Deauville; response according to Lugano). Some of these variables may be the subject of more in-depth evaluations in order to try to better categorize therapeutic responses.
The main objective is to be able to determine for each type of lymphoma which patients will benefit the most from CAR-T treatment and to be able to isolate patients relapsing from their disease after CAR-T very quickly in order to offer them more appropriate therapies
How will the study be carried out?
The study will be based on the analysis of data obtained on centralized PET/CT scan examinations via the LYSA-IM GAELO platform. They are correlated with clinical data from the DESCAR-T registry on the same patients. These analyses will be carried out by the LYSARC team.
The results of these different analyses will then be the subject of various oral presentations or posters at hematology or medical imaging congresses or may be the subject of writings, such as abstracts or articles published in specialized scientific journals. No link can be established between the data contained in these publications or valuations and the patients whose data are collected in DESCAR-T.
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 lymphoma (DLBCL, follicular lymphoma or mantle cell lymphoma) for whom CAR-T treatment (outside of clinical trials) has been administrated in France. Only patients treated in the hospitals mentioned at the beginning of this page are concerned.
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“.