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 efficacy and safety of CAR-T therapies use for the treatment of relapsed or refractory Primary Mediastinal B-cell Lymphoma (PMBL) after at least two lines of treatment.
Why is this project being implemented?
Primary Mediastinal B-cell Lymphoma (PMBL) is a rare disease that accounts for 2% to 4% of non-Hodgkin’s lymphomas. First-line treatments (immunochemotherapies) give generally excellent results and with a cure rate over 80%. However, the 10% to 20% of patients relapsing after or refractory to treatment have a worse prognosis and second line chemotherapies are associated to poorer outcomes.
Axi-cel (Axicabtagen-ciloleucel), an anti-CD19 CAR T-cell therapy, has received European marketing authorization for the treatment of PMBL after promising initial results in cohorts of relapsed or refractory large B-cell lymphomas after at least two lines of treatment. There are still very few data on PMBL, which account for less than 5% of patients in these studies. The treatment efficacy, as well as the risk factors (clinical, biological, metabolic) of failure have been less described.
The aim of this project is therefore to provide additional knowledge to the medical and scientific community regarding the use of CAR T-cell therapies to treat patients with PMBL.
What are the objectives of this project?
This project will analyze real-life data on the use of CAR T-cells in the treatment of relapsed and refractory Primary Mediastinal B-cell Lymphoma. The overall efficacy and risk factors associated to treatment failure will be studied in this particular subpopulation. This project will use data from the patient medical records, including clinical, imaging and biological data, collected in the DESCAR-T registry.
How will the project be carried out?
The project is led by two hematologists of Bordeaux University Hospital, members of LYSA. It will use data from medical records of patients diagnosed with Primary Mediastinal B-cell Lymphoma (PMBL) included in the DESCAR-T registry before March 2023. 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 uses the data of patients included in the DESCAR-T registry, i.e. patients who have received CAR-T treatment in France, and who have been diagnosed with Primary Mediastinal B-cell Lymphoma (PMBL).
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 treatment. 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“.