The REALYSA study aims to improve knowledge about lymphomas and the lives of patients affected by them. Thanks to the large number of participating patients, it enables simultaneous sub‑studies focusing on specific research questions. One of these sub‑studies concerns diffuse large B‑cell lymphomas in older patients.
Why is this study being conducted?
Diffuse large B‑cell lymphoma is the most common lymphoma in older adults. The standard treatment is an immunochemotherapy called R‑CHOP, which combines a monoclonal antibody with several chemotherapy drugs.
In the oldest patients, particularly from age 80 onward, a “reduced‑dose” version of this treatment, called R‑mini‑CHOP, is often used. It relies on lower doses of certain chemotherapy drugs to limit side effects and improve treatment tolerance. However, the choice between these treatments depends on several factors, including the patient’s overall health—not age alone.
Reducing treatment intensity may nevertheless decrease its effectiveness. Some very fit patients, despite their age, may therefore receive a treatment that is less intensive than what they actually need. To date, available data do not provide a clear conclusion on differences in effectiveness between R‑CHOP and R‑mini‑CHOP in older patients.
Using data from the REALYSA cohort, this study aims to better understand the impact of treatment selection around the age of 80. In real‑life practice, treatment strategies change more frequently at this age, making it possible to analyze whether this shift is associated with differences in disease outcomes.
What are the objectives of the study?
The primary objective of this study is to determine whether disease evolution differs around the age of 80, the age at which treatment practices more commonly shift.
The study will also aim to:
• Describe how treatments (R‑CHOP or R‑mini‑CHOP) are used around this age
• Examine whether other factors (comorbidities, frailty, independence, etc.) influence therapeutic decisions
• Compare treatment tolerance, adverse events, disease progression, and deaths not related to lymphoma
How will the study be conducted?
This study will be based on the analysis of data from the medical records of patients participating in REALYSA and the questionnaires already completed by these patients (in particular the quality of life and social support questionnaires).
This study is carried out by Prof. Maynadié and Dr. Tayou of the Dijon University Hospital, in conjunction with Prof. Carras of the Grenoble University Hospital. They will have access to data on all patients with mantle cell lymphoma participating in the REALYSA study. This data will not make it possible to establish a link with the identity of the patients because it is pseudonymised: the first and last names of each person are replaced by a unique number assigned when they are included in REALYSA. LYSARC and its partners cannot link this number to a patient’s identity.
The study is scheduled to begin in March 2026.
TO THE ATTENTION OF PATIENTS PARTICIPATING IN REALYSA
What does this study mean for you?
This study involves only REALYSA participants diagnosed with diffuse large B‑cell lymphoma who were aged 60 years or older at diagnosis.
If you are in this situation and agree to have your data used for this study, there is no direct implication for you.
In particular, you will not be asked to complete any additional questionnaire beyond what is already planned as part of REALYSA.
What should you do regarding this study?
Two options are possible:
- You do not object to the use of your data for this study:
- In this case, you do not need to do anything.
- You wish to object to the use of your data for this study:
- In this case, you must inform the physician who invited you to participate in REALYSA.
- You may also express your decision by sending an email to: 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 notice you received when you agreed to participate in REALYSA.