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-ife setting.
Using the registry data, research projects to answer specific questions can be undertaken. One of these projects is investigating whether there is a link between the use of proton pump inhibitor (PPI) drugs and the rate of relapse after CAR-T cell therapy in patients with refractory or relapsed non-Hodgkin B-cell lymphoma (B-NHL), including refractory or relapsed diffuse large cell B-cell lymphoma (DLBCL).
Why is this analysis being implemented?
Les CAR-T sont des thérapies innovantes, proposées depuis plus de cinq ans déjà à certains patients atteints de LBDGC en rechute ou réfractaire après au moins deux lignes de traitement. Cependant, certains patients peuvent rechuter dans les 12 mois à la suite de ce traitement.
De précédentes études ont mis en évidence une augmentation du risque de rechute chez les patients ayant reçu des IPP pendant un traitement par immunothérapie. D’autres études ont montré que l’exposition aux antibiotiques influence la réponse aux CAR-T. En sachant qu’environ un quart de la population française est exposée aux IPP, et qu’ils peuvent impacter le microbiote digestif de façon comparable à des antibiotiques, il est nécessaire d’évaluer l’impact de la prescription de cette classe médicamenteuse sur les réponses thérapeutiques au cours du traitement des LBDGC afin d’optimiser la prise en charge des patients.
Le registre DESCAR-T collecte des données issues des dossiers médicaux des patients à qui sont proposés des CAR-T en France, qu’ils reçoivent finalement des CAR-T ou non. Ces données permettent de mieux comprendre les caractéristiques de la maladie et le profil de ces patients.
Quels sont les objectifs de l’étude ?
The primary objective of the study is to assess the risk of relapse after CAR T-cell therapy in patients with B-NHL following PPI exposure compared to unexposed subjects.
In a second step, it will make it possible to evaluate the frequency of occurrence of side effects related to CAR-T in patients who have been exposed to PPIs or not.
How will the analysis be carried out?
The study will be based in part on the analysis of data from the DESCAR-T register. This study is carried out by Eva Desbrousse, resident in clinical hematology under the supervision of Dr. VALLET of the Bretonneau Hospital in Tours. He will have access to data on all patients with DLBCL lymphoma who participate in the DESCAR-T study. This data will not make it possible to establish a link with the identity of the patients because it is 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 final analysis of these results will be presented at conferences and will be published in a scientific article 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 non−Hodgkin B-cell lymphoma (B-NHL), in particular refractory or relapsed diffuse large cell B-cell lymphoma (DLBCL), for whom CAR-T treatment (outside of clinical trials) has been considered in France after two other lines of treatment for this disease.
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“