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 SYNTH-L, involves patients who have Hodgkin lymphoma. This study aims to improve the research for new treatments for these patients.
Why is the SYNTH-L study being implemented?
Although there is an effective standard treatment for a majority of elderly patients with a Hodgkin lymphoma, the search for new treatments remains essential. Several therapeutic strategies are being developed for these patients. In order to be able to identify the most promising strategies as early as possible, it is necessary to develop new research methods. This is the goal of the SYNTH-L study.
In traditional clinical trials, two groups of patients are formed: patients receive in the first group an experimental treatment, in the second group the reference treatment (also called “control”). It is the comparison between the two groups that makes it possible to know whether the experimental treatment provides an advantage over the reference treatment.
However, these traditional trials take a long time to complete. In order to move faster, the researchers are developing a new way of doing things: to build a single group of patients, receiving the experimental treatment, and compare it to a group of patients participating or having participated in other trials or studies. This control group is called “synthetic”.
To build this “synthetic” control group, researchers use data from patients who have participated in completed trials or who are being followed in studies such as REALYSA. These patients are selected so that the “synthetic” control group resembles as closely as possible the group of patients receiving the experimental treatment. Thus, the comparison between the two groups can be made more quickly.
What are the objectives of the SYNTH-L study?
The objective of this study is to develop the method for forming “synthetic” control groups of patients aged 80 years and older who have Hodgkin lymphoma.
These “synthetic” control groups can thus be created and used as a point of comparison in various ongoing or future trials. It will make it possible to know which therapeutic strategies evaluated in these trials are the most interesting.
How will the SYNTH-L study be conducted?
The SYNTH-L study will be based on the analysis of data from the medical records of patients participating in REALYSA or having participated in various clinical trials conducted by LYSA, as well as data from patient medical records in some hematology centres (routine management).
It will not be possible to establish a link between the data and the identity of the patients because data are pseudonymized: the name and surname of each person are replaced by a unique number assigned at inclusion in REALYSA. LYSARC and its partners cannot link this number to a patient’s identity.
The SYNTH-L study is carried out by Dr Cédric Rossi, Dr Amira Marouf, Dr Bénédicte Deau-Fischer and Professor Hervé Ghesquières.
The study is scheduled to begin in 2023.
A l’attention des patients participant à REALYSA
What does the SYNTH-L study mean for you?
This study is only for patients participating in REALYSA who have a Hodgkin lymphoma.
If you are in this situation and you agree that your data is 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 the SYNTH-L study?
There are two options:
- You are not opposed to the use of your data and samples in the context of study SYNTH-L:
- In this case, you don’t have to do anything
- You wish to object to the use of your data in the context of study SYNTH-L:
- 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.