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 focuses on patients above 80 that have been considered eligible for CAR-T therapy.
Why is this project being implemented?
CAR T-cells are innovative therapies used to treat different types of lymphoma, with a high cost. It is important to be able to better predict which patients will benefit most, for the longest duration, or conversely which patients won’t benefit from these treatments. Firstly, to provide the best possible care for each patient, and secondly, to make the best possible use of healthcare resources across the society as a whole.
Patients’ age is therefore an important factor to consider. It is often associated with a frailer general state of health, which is an important element for doctors to consider when they decide to prescribe therapies that can have serious toxic effects. Hence the importance to better understand the balance between potential risks and expected benefits of CAR T-cells in this population.
Patients’ age is also a factor to be considered in the assessment of the cost-effectiveness of a treatment, which is a matter of general interest to our societies. The effectiveness of a treatment is related to the number of years that patients who receive the treatment will gain compared to those who do not.
It is rare that doctors prescribe CAR T-cells to patients aged over 80, so it is important to describe the profile of these patients, as well as the efficacy and toxicity of CAR T-cells in this population.
What are the objectives of this project?
This project is looking at the real-world-use of anti-CD19 CAR T-cells prescribed to patients over the age of 80. The data used will come from patient medical records collected in the DESCAR-T registry.
How will the project be carried out?
The project is led by an intern in hematology at Rennes University Hospital. It will use data from medical records collected in the DESCAR-T registry before March 2023 of patients meeting the inclusion criteria for this research project. 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 been prescribed CAR-T treatment in France, and who were above 80 years old at that time.
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