REALYSA study aims to improve knowledge about lymphomas and the lives of lymphoma patients Thanks to the large number of patients involved, it allows sub-studies to be conducted simultaneously on specific research questions. One of his substudies involves patients with mantle cell lymphoma.
Why is this study being implemented?
Mantle cell lymphomas are a rare form of lymphoma that affects middle-aged adults. They are characterized by the presence of cancer cells in a specific region of the lymph nodes or organs, called the mantle zone.
These lymphomas are diagnosed by specific biological features of the tumor cells. The first treatment is usually chemotherapy combined with a monoclonal antibody directed against the tumor cells. In younger patients, therapeutic intensification followed by autologous hematopoietic stem cell transplantation is sometimes proposed. In all cases, maintenance treatment with a monoclonal antibody for several years is then offered.
Despite these treatments, mantle cell lymphoma remains an incurable disease, with repeated relapses. Several types of treatment are available for relapse. This is most often immunochemotherapy or a combination of targeted therapies. These treatments are sometimes very effective. However, this effectiveness is not found in all patients.
Treatment recommendations for mantle cell lymphoma have been modified several times in recent years based on developments in research. As a result, there is no very precise information on the treatments that are currently offered to patients in “real life”, in first-line or at relapse. The REALYSA study will make it possible to obtain this information.
What are the objectives of the study?
The study aims to describe who are the patients suffering from mantle cell lymphoma treated in 1st or 2nd line. Demographic data, as well as their state of health and its evolution will be analyzed.
The study also aims to describe what treatments these patients received and with what effectiveness.
These so-called “real-life” data (as opposed to clinical trials) will be useful to better understand how patients are cared for and define what improvements should be considered. They will thus make it possible to improve future therapeutic protocols.
How will the study be conducted?
The study will be based on the analysis of data from the medical files of patients participating in REALYSA. These analyzes will be carried out by members of LYSARC.
This study is carried out in collaboration with Dr. Morgane Cheminant (Necker Hospital, AP-HP, Paris) and the Astra-Zeneca laboratory, partner of REALYSA. The laboratory will only receive descriptive reports without individual data. No link can be established between the data contained in the reports and the patients participating in REALYSA.
The results transmitted to Astra-Zeneca will be used for regulatory files for French health authorities in order to provide information on current patient care.
The study will begin in March 2024.
TO THE ATTENTION OF PATIENTS PARTICIPATING IN REALYSA
What does this study mean for you?
This study only concerns patients participating in REALYSA who have diffuse mantle cell lymphoma.
If you are in this situation and you agree to your data being used for this study, this has no direct implication 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.
What should you do about this study?
There are two options:
- You do not object to the use of your data in the context of the study:
è In this case, you don’t have to do anything
- You wish to object to the use of your data in the context of the study:
è In this case, you must inform the doctor who suggested 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 about your rights to object to the use of your data on page 12 of the information provided to you when you agreed to participate in REALYSA.