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 treated with CAR T-cells and the efficacy and safety of these therapies in patients diagnosed with Lymphoma or Acute Lymphoblastic Leukemia (ALL) after at least two previous lines of cancer therapy.
Why is this analysis being implemented?
CAR T-cells are innovative therapies that have been offered for more than five years to some patients with lymphoma or ALL after at least two lines of treatment.
Rare complications (1 to 2%) may occur during this treatment, such as macrophage activation syndrome (MAS), which is often life-threatening. This syndrome combines non-specific clinical signs such as fever or deterioration of general condition, and suggestive biological elements such as alteration of liver function tests, increase in LDH, ferritin and triglycerides. These non-specific signs make MAS difficult to diagnose and treatment unsuitable.
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.
This project therefore aims to provide the medical and scientific community with original elements of knowledge concerning the occurrence of MAS in patients suffering from lymphoma and ALL in order to improve its management.
What are the objectives of the analysis?
The study aims to first describe the real-life outcome of lymphoma and ALL patients who developed MAS during CAR-T cell therapy. Secondarily, the objectives will be to describe the population with MAS, and to evaluate the efficacy and safety of this treatment in these patients.
How will the analysis be carried out?
This project is led by Dr. Jérôme Paillassa from the University Hospital of Angers and Nicolas Gower, medical intern from the University Hospital of Lille, representing Lysa, in partnership with the GRAAL (Group for Research on Adult Acute Lymphoblastic Leukemia) and the SFCE (French Society for the Fight against Childhood and Adolescent Cancer and Leukemia).
The study will be based on the analysis of DESCAR-T data. The data used in this project does not allow LYSARC and the researchers to link it to the identity of the patients because it is pseudonymized: a unique number is associated with each patient when included in the registry.
This study will be conducted in June and July 2024 and the results are expected to be reported at the American Society of Hematology (ASH) International Congress in December 2024. It will also be the subject of Nicolas Gower’s medical thesis and should 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 Lymphoma or ALL, for whom CAR T-cell therapy has been considered (outside clinical trials) in France after two other lines of treatment for this disease, and for which a MAS has been declared.
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“