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 INTENSIFY, focuses on patients with large B-cell lymphoma.
Why is this study being implemented?
Large B-cell lymphoma (LBCL) is an aggressive but curable disease, with 60% to 70% of patients experiencing 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 therapeutic advances, including CAR-T cells and bispecific antibodies.
Variability in treatment efficacy from one patient to another indicates that our understanding of tumor biology and mechanisms remains incomplete.
To date, several tools (called markers or prognostic factors) help determine the risk of progression for each patient before starting treatment. These tools include the International Prognostic Index (IPI), PET imaging and biological markers such as the amount of circulating tumor DNA (tumor DNA that circulates in the blood and can be identified because tumor cells have a different DNA from that of normal cells). However, these tools are usually analyzed independently of each other.
What are the objectives of the study?
The INTENSIFY project aims to integrate all these prognostic factors via a multi-modal approach in order to identify patients at risk of relapse or refractory to the first line of treatment. This approach involves combining several types of information about patients with large B-cell lymphoma. This includes the analysis of various elements such as clinical data, PET scans and biological analyses (including genetic data). This approach provides an overview of the disease for each patient, taking into account different factors that could influence the treatment and course of the disease. By integrating all this information, the researchers hope to better identify at-risk patients and develop more personalized treatments.
How will the study be carried out?
Data and patient samples included in completed clinical trials of LYSARC and REALYSA will be pooled and made available to researchers. This represents approximately 5000 LBCL patients treated in primary care, which will generate robust results.
The study will be based on the analysis of clinical data collected from medical records, the analysis of PET CT images, the analysis of biopsies (biological analysis and image analysis), as well as on advanced biological analyses on various types of samples already carried out within REALYSA.
For REALYSA, this project requires the biological collection and analysis of tumor blocks that have been taken as part of the diagnosis. PET images will also be centralized and analyzed by researchers.
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, the researchers and all the project partners cannot make the link between this number and the identity of a patient.
L
ed by LYSA, the INTENSIFY study is coordinated by Dr. Sydney Dubois (Henri Becquerel Center in Rouen) and Dr. Pierre Sesquès (Hospices Civils de Lyon).
TO THE ATTENTION OF PATIENTS PARTICIPATING IN REALYSA
What does the INTENSIFY study mean for you?
This study is only in patients participating in REALYSA who have diffuse large B-cell lymphoma.
If you are in this situation and you agree to have your data and biological samples used for the study, it has no direct implications for you.
In particular, you will not have any additional deductions compared to what is already planned as part of your participation in REALYSA.
What do you have to do about the 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.