The REALYSA study aims to improve knowledge about lymphomas and the lives of patients with lymphomas. Thanks to the large number of patients who participate, it allows sub-studies to be conducted simultaneously on specific research questions. One of its sub-studies is in patients with peripheral T-cell lymphoma.
Why is this study being implemented?
Peripheral T-cell lymphomas (called PTCL) are a rare and complicated group of cancers. They are difficult to treat and still poorly understood in many aspects.
The initial management of these lymphomas can vary from hospital to hospital, and most clinical trials have failed to demonstrate a clear benefit of the new therapeutic strategies compared to the standard CHOP chemotherapy protocol.
However, progress has been observed in some types of T-cell lymphoma: in patients with anaplastic large cell lymphoma, for example, the combination of Brentuximab Vedotin and chemotherapy (CHP) has shown an improvement compared to CHOP.
The question of the use of stem cell transplantation (autologous or allogeneic) from the first line of treatment remains controversial, with practices that vary greatly depending on the hospital.
Due to their rarity, the data available outside of clinical trials are limited. There is little information about real-life care.
It is in this context that the REALY-T study makes a valuable contribution. The analysis of data from REALYSA’s more than 300 patients with peripheral T-cell lymphoma allows an in-depth description of the clinical profile of these patients, the treatments actually received, and the results observed in real life (during routine management).
What are the objectives of the study?
The study aims to describe patients with peripheral T-cell lymphoma. Demographic data, as well as their state of health and the evolution of it, will be analyzed.
The study also aims to find out what treatments these patients received and how effectively.
This so-called “real-life” data (as opposed to clinical trials) will be useful to better understand how patients are being cared for and what improvements should be considered. They will thus make it possible to improve future therapeutic protocols.
How will the study be carried out?
The study will be based on the analysis of data from the medical records of patients participating in REALYSA. These analyses will be carried out by members of LYSARC.
This study is carried out in collaboration with Dr. Edith Julia (Lyon Sud Hospital, Hospices Civils de Lyon, Pierre-Bénite) and Dr. Sylvain Carras (Grenoble University Hospital), members of LYSA. They will have access to data on all patients with peripheral T-cell lymphoma participating in the REALYSA study. 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 they are included in REALYSA. LYSARC and its partners cannot link this number to a patient’s identity.
The study is scheduled to begin in June 2025.
TO THE ATTENTION OF PATIENTS PARTICIPATING IN REALYSA
What does this study mean for you?
This study is only for patients participating in REALYSA who have peripheral T-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.
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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 suggested that you participate in the REALYSA study. 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.