The REALYSA study aims to improve knowledge about lymphomas and the lives of lymphoma patients. Thanks to the large number of patients involved, it allows sub-studies on specific research questions to be conducted simultaneously. One of these substudies, called ESCAPE, involves T-cell lymphomas.
Why is the ESCAPE study being implemented?
T–cell lymphomas are a group of very heterogeneous and aggressive lymphomas. These lymphomas have generally a rather poor prognosis and because of their rarity few clinical trials are dedicated to them. Over the past twenty years, the only treatment that has received first–line marketing authorization is Brentuximab Vedotin (Adcetris®), in combination with chemotherapy. Brentuximab Vedotin is a monoclonal antibody (anti–CD30) conjugated to a cytotoxic molecule. The antibody targets a biomarker (CD30) expressed on the surface of lymphoma cells. This biomarker can also be found in soluble form circulating in the blood.
What are the objectives of this study?
The objective of this study is to investigate the association between the amount of soluble CD30 biomarker at diagnosis and the response to treatment in peripheral T–cell lymphomas. The study will also look at the link between the expression of the biomarker on lymphoma cells and in its soluble form.
How will this study be conducted?
The study will be based on the analysis of data from the medical records of patients participating in REALYSA. The biological samples (serum) taken during your follow–up in REALYSA will be analyzed by a partner laboratory to determine the amount of soluble biomarkers according to techniques validated in other studies. The statistical analyses will then be carried out by members of LYSARC.
This study is carried out by Pr Gandhi Damaj, hematologist at the University Hospital of Caen and Pr Marie-Hélène Delfau-Larue, biologist at Hôpital Henri Mondor. They will have access to data on all T–cell patients participating in the REALYSA study. These data will not make it possible to establish a link with the identity of the patients because they are pseudonymized: the name and surname of each person are replaced by a unique number assigned during inclusion in REALYSA. LYSARC and its partners cannot link this number to a patient‘s identity.
The study is scheduled to begin in 2023.
FOR PATIENTS PARTICIPATING IN REALYSA
What does this study mean for you?
This study is only for patients with T-cell lymphoma in REALYSA.
If you are in this situation and you agree to your data and biological samples 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, and you will not have to have any additional blood sampling.
What should you do about this study?
There are two options:
- You are not opposed to the use of your data and samples 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 suggested 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 about your rights to object to the use of your data on page 12 of the information provided to you when you agreed to participate in REALYSA.