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, called “HR-Low-IPI,” is in patients with diffuse large B-cell lymphoma.
Why is this study being implemented?
Diffuse large B-cell lymphoma (DLBCL) is an aggressive but curable disease: 60% to 70% of patients will experience long-term remission with the standard chemoimmunotherapy, R-CHOP. However, for the 30% to 40% of patients with relapsed or treatment-refractory disease, the course of the disease remains uncertain despite recent advances in treatment options, including CAR-T cells and bispecific antibodies.
To date, there are several assessment tools that help determine the risk of progression of their lymphoma for each patient before starting treatment (called markers or prognostic factors). The most frequently used is the International Prognostic Index (IPI). Recently, it has been shown that in the group of low-risk patients according to IPI (IPI 1 or 2), the course of the disease is unfavorable for a number of patients. Initial results in an American study have shown that by adding 2 simple clinical criteria (the level of a biomarker and the presence of a large mass), it is possible to better identify these high-risk patients and thus be able to adapt their management.
What are the objectives of the study?
The “HR-Low-IPI” project aims to confirm the interest of these new prognostic criteria on French data in order to improve the identification of patients at high risk of relapse or refractory to the first line of treatment. Doctors hope to better identify patients at risk and be able to adapt their care.
How will the study be carried out?
The study will be based on the analysis of clinical data collected from medical records already collected within REALYSA.
The data analysed in this study will not make it possible to establish a link with the identity of the patients because they are pseudonymised: the first and last names of each person are replaced by a unique number assigned at the time of inclusion in REALYSA. LYSARC and all the project partners cannot make the link between this number and the identity of a patient.
This study is carried out in collaboration with Prof. Hervé Ghesquières (Lyon Sud Hospital, Hospices Civils de Lyon), Prof. James Cerhan (Mayo Clinic, United States) and the laboratories at Bristol Myers Squibb, 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 analysis is scheduled to begin in June 2025.
TO THE ATTENTION OF PATIENTS PARTICIPATING IN REALYSA
What does this project implies for you?
This study only includes patients participating in REALYSA who have diffuse large B-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 any additional deduction compared to what is already provided for as part of your participation in REALYSA.
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. 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.