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.
The registry data really enables the realization of projects to answer specific research questions. One of these projects focuses on the impact of exposure to Fludarabine during lymphodepletion in patients treated with Axi-cel on the clinical response of patients in terms of survival, its progression in the DESCAR-T registry population.
Why is this project being implemented?
Patients treated with CAR-T cells receive lymphodepleting chemotherapy prior to their administration. Several studies have shown that exposure to Fludarabine can be estimated to optimize the effectiveness of CAR-T cells. These recent studies have shown that a dose calculation based on the estimated exposure to fludarabine improves the effectiveness and tolerance of CAR-T cell treatment. A preliminary monocentric study (conducted at the Henri Becquerel Center in 2024) using this modeling method, showed the importance of expanding the patient cohort to obtain more significant and representative results from the general population.
What are the objectives of this project?
The main objective of this study is to retrospectively investigate the impact of fludarabine exposure on the efficacy and toxicity of Axi-cel in the treatment of large cell B-cell lymphomas in the DESCAR population-T. The data used will come from the patients’ medical records, including clinical data, pharmacy data and biological data, collected as part of the DESCAR-T register.
How will the project be carried out?
The project is led by a pharmacist from the CHB in Rouen and a hematologist who is a member of LYSA. It will use data from the medical records of patients diagnosed from January 2016 to August 2025 for large cell B-cell lymphoma treated with Axi-cel included in the DESCAR-T registry. These data are pseudonymized and as such cannot be linked to a patient identity, i.e. a unique number is associated to each patient included in the registry. The LYSARC and the researchers cannot link this number to the identity of an individual.
FOR PATIENTS HAVING RECEIVED CAR-T IN FRANCE
What does this project involve for you?
This project concerns patients included in the DESCAR-T registry, patients diagnosed with primitive mediastinal cell B lymphoma (PMBL), relapsing after receiving treatment for CAR-T in France.
If you are in this situation and you accept that your data will be used for this project, this has no direct implication for you.
What should you do about this project?
There are two options:
- You do not object to the use of your data for this project:
=> in this case, you do not have to do anything
- You wish to object to the use of your data in this project:
⇒ in this case, please inform the doctor at the center where you have received your CAR T- treatement. You can also notify your decision by email at : dpo@lysarc.org.
You can find more information about your rights to object to the use of your data on the page “I am participating or have participated in a clinical trial