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 BIDIFLY, focuses on patients who have follicular lymphoma.
Why is the BIDIFLY study being implemented?
Follicular lymphoma (FL) is the most common subtype of indolent (i.e., slow-growing) lymphoma. This type of lymphoma is characterized by a heterogeneous evolution from one patient to another, ranging from a very indolent disease to an aggressive form after transformation into diffuse large B-cell lymphoma (DLBCL). Given this heterogeneity, it is necessary to better identify the risk of their lymphoma evolving for each patient, in order to be able to offer them appropriate care.
What are the objectives of the BIDIFLY study?
Two categories of patients with follicular lymphoma are currently distinguished:
- “LTB” patients (for Low Tumor Burden): this concerns asymptomatic patients (without symptoms), who have a slow progression of the disease and who receive only immunotherapy treatment as long as their lymphoma does not progress.
- “HTB” patients (for High Tumor Burden): these are symptomatic patients (with symptoms) who require immunochemotherapy treatment.
The BIDIFLY study aims to meet four objectives:
- Among so-called “HTB” patients, 20% have an early relapse of their lymphoma, i.e. during the 24 months following the start of treatment. These are the so-called “POD24” patients.
OBJECTIVE 1: To develop a predictive score for POD24 that will allow the selective recruitment, in future clinical trials, of patients with the highest risk of lymphoma progression and those at low risk, in order to be able to offer them appropriate treatments.
- Among so-called “LTB” patients, 20% still do not need to receive chemotherapy treatment 20 years after diagnosis. On the other hand, patients have a similar course of lymphoma over time to that of so-called “HTB” patients and therefore require chemotherapy treatment.
AIM 2: To develop a score predicting the time from diagnosis to initiation of immunochemotherapy for initially low-risk patients (“LTB”), in order to be able to evaluate a longer maintenance treatment strategy for those at highest risk.
- Follicular lymphoma also has a strong heterogeneity at the molecular level. It is likely that it will be necessary to adapt treatments according to biological parameters.
OBJECTIVE 3: To develop a new classification of follicular lymphomas based on a set of clinical, biological and imaging data (theranostic classification), in order to develop personalized medicine approaches.
- It is now established that follicular lymphoma relapses are linked to the presence of “precursor cancer cells” (or PCCs) in the body. These cells form a reservoir that treatments fail to eliminate, leading to the appearance of new cancer cells and therefore to the relapse of the disease. It is therefore necessary to better characterize CPCs, which could make it possible to identify new therapeutic strategies
OBJECTIVE 4: To better understand the functioning of the tumor cell environment in patients with follicular lymphoma, particularly at the level of CPCs, in order to identify new targets for treatments.
How will the BIDIFLY study be carried out?
Data and patient samples included in completed LYSARC clinical trials will be shared and made available to researchers. This represents approximately 2610 patients with follicular lymphoma treated in first line, which will generate robust results.
The study is based on the pooling of clinical data collected from patients’ medical records, imaging data (PET scanner and biopsy slides), and biological data from blood, bone marrow or a biopsy. All this data will be stored, pooled and analyzed within a tool developed by the CALYM Carnot Institute and called the Lymphoma Data Hub (LDH). The hypothesis of the study is that the integration of these different types of data will make it possible to propose a new classification of follicular lymphoma that can both improve the understanding of the heterogeneity of this disease and guide the future management of patients.
The data and samples from the REALYSA cohort will be used to validate the predictive scores developed in the framework of the BIDIFLY project.
In this context and for about 800 REALYSA patients, PET CT images taken at various collection times, but also biopsy blocks taken as part of the diagnosis will be collected by LYSARC and analyzed by the researchers.
The plasmas already centralized in the REALYSA project at various collection times will also be analyzed by the researchers.
The data analyzed in this study will not make it possible to establish a link with the identity of the patients because they are pseudonymized: 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.
Led by LYSA, the BIDIFLY study is coordinated by Dr. Clémentine Sarkozy (Institut Curie in Paris)
The collection of imaging data and biopsy samples from REALYSA patients within the study began in 2024. The analyses will be carried out over several years.
FOR THE ATTENTION OF PATIENTS PARTICIPATING IN REALYSA
This study involves only patients participating in REALYSA who have follicular 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 blood sampling 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 and samples in the context of the study:
In this case, you don’t have to do anything
- You wish to object to the use of your data and samples in the context of the 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.