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 PMBL REALYSA, focuses on patients with primary mediastinal large B-cell lymphoma.
Why is this study being implemented?
Primary mediastinal large B-cell lymphoma is a rare type of lymphoma. It is a disease that can be treated well with an initial treatment: more than 8 out of 10 patients no longer have any signs of the disease five years later. Since most patients are fine after this treatment, doctors are now looking to decrease the intensity of certain treatments (this is called therapeutic de-escalation) to avoid long-term side effects, while keeping the same effectiveness.
However, 10-15% of patients have relapse or refractory disease (which does not respond to first-line treatment). In these situations, the course of the disease is generally more unfavorable and it is still unclear how best to treat these people because there are few studies. Many approaches are being explored in therapeutic trials, including immunotherapies (which help the immune system attack cancer) and CAR T-cell therapies that have emerged as promising options in this context.
Real-world data on primary mediastinal large B-cell lymphoma remain scarce. This study will provide valuable information on management, response to treatment and long-term disease progression, both in primary care and in relapse situations.
By improving our knowledge of these rare lymphomas, the REALYSA PMBL study could help improve therapeutic strategies and guide future clinical trials, in particular to optimize treatment intensity and integrate new immunotherapies.
What are the objectives of the study?
The study aims to describe patients with primary mediastinal large B-cell lymphoma treated in the 1st or 2nd line. Demographic data, as well as their state of health and the evolution of it, will be analyzed.
The study also aims to find out what treatments these patients received and how effectively.
This so-called “real-life” data (as opposed to clinical trials) will be useful to better understand how patients are managed and what improvements should be considered, especially in clinical trials.
How will the study be carried out?
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 Dr. Vincent Camus (Henri Becquerel Center, Rouen) and Dr. Loïc Renaud (Gustave Roussy Institute, Villejuif). Histopathological expertise will be provided by Dr. Marie Donzel and Alexandra Traverse-Glehen (Hospices Civils de Lyon), and expertise in medical imaging by Dr. Pierre Decazes (Henri Becquerel Center, Rouen) and Dr. Anne-Ségolène Cottereau (AP-HP, Paris).
No link can be made between the data contained in the reports and the patients participating in REALYSA.
TO THE ATTENTION OF PATIENTS PARTICIPATING IN REALYSA
What does this project implies for you?
This study only concerns patients participating in REALYSA who have primary mediastinal 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 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 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.