The REALYSA study and the DESCAR-T registry aim to improve knowledge about lymphomas and the lives of patients with lymphoma. Thanks to the large number of patients who participate, these “real-life” initiatives allow for simultaneous sub-studies on specific research questions. One of these sub-studies concerns relapsed or refractory large B-cell lymphomas.
Why is this study being implemented?
Diffuse large B-cell lymphoma is the most common type of non-Hodgkin lymphoma.
Current treatments make it possible to obtain a cure in a majority of patients. However, in some patients, these treatments are not sufficiently effective. Either the disease does not evolve favorably (it is then said to be “refractory”), or it relapses after a period of remission.
Several types of treatment are possible in “second line”. This is often a new immunochemotherapy. This can be followed, for the youngest patients (generally under 65 years of age), by an autologous hematopoietic cell transplant. Treatment with CAR-T cells has been another treatment option since the summer of 2022.
CAR T cells (Chimeric Antigen Receptor T-cells) are T cells that are reprogrammed in the laboratory to recognize and destroy cancer cells. Taken from the patient, the T lymphocytes are genetically modified to express a specific receptor, allowing them to target diseased cells, and then reinjected into the patient. A true “living drug”, CAR T cells multiply and persist in the body, offering a new therapeutic weapon against several blood cancers, including lymphomas, leukemias and myelomas.
The superiority of the efficacy of CAR-T cell therapies compared to the standard of treatment in refractory or early-relapsed diffuse large cell lymphoma has been shown in randomized clinical trials, but it is important to evaluate in real life (i.e. in routine use) whether this superiority in efficacy is well confirmed.
What are the objectives of the study?
The objective of this study is to compare the efficacy of CAR T-cell treatments with the standard of immunochemotherapy treatment (followed or not by an autologous transplant) in a real-life setting.
How will the study be carried out?
This study will be based on the analysis of data from the medical records of patients participating in REALYSA and DESCAR-T. Statistical methods will be used to make the patient populations comparable in the 2 groups and thus produce more robust results.
These analyses will be carried out by members of LYSARC.
This study is led by Dr. Brisou, a Physician at the Paoli Calmettes Institute in Marseille, and Prof. Tessoulin of the Nantes University Hospital. They will have access to data on all patients with large B-cell lymphoma who participate in the REALYSA study or the DESCAR-T registry. This data will not make it possible to establish a link with the identity of the patients because it is pseudonymised: the first and last names of each person are replaced by a unique number assigned when included in REALYSA or DESCAR-T. LYSARC and its partners cannot link this number to a patient’s identity.
This work has benefited from a grant granted by the CALYM Carnot Institute, under the “Carnot Scheme”, managed by the French National Research Agency (ANR).
The study is scheduled to begin in June 2025.
TO THE ATTENTION OF PATIENTS PARTICIPATING IN REALYSA
What does this project implies for you?
This study is only for patients participating in REALYSA or DESCAR-T who have large B-cell lymphoma.
If you are in this situation and you agree to have your data used for this study, it has no direct implications for you.
In particular, you will not have to answer any additional questionnaire compared to what is already planned as part of your participation in REALYSA or DESCAR-T.
What should you do about this study?
There are two options:
- You are not opposed to the use of your data in the context of this study:
- In this case, you don’t have to do anything.
- You wish to object to the use of your data in the context of this study:
- In this case, you must inform the doctor who offered you to participate in the REALYSA study or DESCAR-T. You can also notify your decision by writing an email to the following address: dpo@lysarc.org .
You will find detailed information on your rights to object to the use of your data on page 12 of the information notice that was given to you when you agreed to participate in REALYSA or DESCAR-T.