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 is looking at the impact of B-aplasia (a sharp drop in B-cells, a type of white blood cell), reflection of CAR T cell persistence, on the incidence and nature of relapses in patients with Acute Lymphoblastic Leukemia (ALL) following CAR T-cell therapy.
Why is this study being implemented?
CAR-T cells have shown very promising results. However, the hindsight remains insufficient to date. The first pitfalls appear in the medium term, including the loss of persistence of CAR-T cells, which exposes the risk of relapse.
Indeed, usually, after infusion, CAR T cells expand and can persist over a very long time. The disappearance of B lymphocytes (“B aplasia”) is a marker of the persistence of these CAR-T, and seems to be correlated with the persistence of remission in ALL as demonstrated in the phase I-II clinical trial “ELIANA”.
This study is being conducted to compare results obtained in a small number of patients in a clinical trial population to a more diverse population in a real-life setting.
What are the objectives of the study?
This study has two major objectives:
- To describe the duration of B-aplasia in patients treated with Tisa-cel (Kymriah) for ALL among patients registered in DESCART and corresponding to the inclusion/exclusion criteria of the ELIANA protocol, and to compare this duration to that obtained in the context of ELIANA;
- To describe the relapses (number, type) of DESCAR-T patients comparable to ELIANA patients.
How will the study be carried out?
This study is led by Dr. Marie-Emilie DOURTHE of the Robert Debré Hospital (Greater Paris University Hospitals).
The study will be based on the analysis of data from the DESCAR-T registry. The analysis will be carried out by the project leader.
This study will be carried out at the end of 2024 and the results are expected to be communicated at international hematology congresses and in a scientific article in 2025.
FOR PATIENTS WHO HAVE BEEN OFFERED CAR-T THERAPY IN FRANCE
What does this project mean for you?
This project concerns patients included in the DESCAR-T registry, diagnosed with B-ALL, aged 0 to 25 years, for whom CAR-T treatment (outside of clinical trials) has been performed 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
- 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“.