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 diffuse large B-cell lymphoma who are receiving or have received 2nd line of therapy.
Why is this study being implemented?
Diffuse large B-cell lymphoma is the most common type of non-Hodgkin lymphoma. Approximately 40% of patients participating in REALYSA have this 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 progress favorably (it is then called “refractory”), or it relapses after a period of remission.
Several types of treatment are possible in the “second line”. This is often a new immunochemotherapy. This can be followed, for the youngest patients (usually under 65 years of age), by an autologous hematopoietic cell transplant. CAR-T cell therapy has been another treatment option since summer 2022.
At present, the characteristics of patients with diffuse lymphoma who require a 2nd treatment and how they are managed are not sufficiently well known. REALYSA will improve knowledge of these patients.
What are the objectives of the study?
The study aims to describe which patients with diffuse large B-cell lymphoma should receive a 2nd treatment. Demographic data, as well as on their state of health and its evolution will be analyzed.
The study also aims to find out which 2nd treatment these patients received and with what effectiveness.
This so-called “real-life” data (as opposed to clinical trials) will be useful to better understand how patients are managed and whether improvements should be considered. They will also be used to compile files for the French health authorities.
How will the study be conducted?
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 the BMS laboratory, a partner of REALYSA. The laboratory will only receive descriptive reports without individual data. No link can be made between the data contained in the reports and the patients participating in REALYSA.
The results sent to BMS will be used to compile dossiers for the French health authorities.
The study is scheduled to begin in April 2023.
TO THE ATTENTIONOF PATIENTS PARTICIPATING IN REALYSA
What does this study mean for you?
This study only concerns patients participating in REALYSA who have diffuse large B-cell lymphoma and who have received a 2nd treatment for their 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.