The DESCAR-T registry was set up at the request of health authorities to improve knowledge about CAR-T cell therapies marketed in France for treating patients with malignant hematology. The objective of this register is to support data on the short- and long-term efficacy and tolerance of these treatments in real life.
Using the data collected, the registry allows projects to be conducted to answer specific research questions. One of these projects focuses on the results of the comparison of axi-cel and liso-cel as second line therapy for relapsed/refractory large B cell lymphoma.
Why is this project being implemented?
Axicabtagene ciloleucel (axi-cel) and Lisocabtagene maraleucel (liso-cel), two anti-CD19 CAR T-cells, have been approved as second line (2L) treatment in relapsed/refractory (R/R) large B-cell lymphoma (LBCL) for patients progressing within 12 months of first-line chemo-immunotherapy. No comparative data on the efficacy and safety of these two treatments is available and no prospective trial will ever be conducted to compare these two treatments head-to-head.
What are the objectives of the LBCL 2L axi vs liso study?
The main objective of this study is to retrospectively investigate the impact of fludarabine exposure on the efficacy and toxicity of Axi-cel in the treatment of large cell B-cell lymphomas in the DESCAR population-T. The data used will come from the patients’ medical records, including clinical data, pharmacy data and biological data, collected as part of the DESCAR-T register.
How will the project be conducted?
This study is led by Dr. Gabriel BRISOU, hematologist at the Paoli Calmette Institute (ICP) in Marseille, and Dr. Benoît TESSOULIN, hematologist at Nantes University Hospital. This study is based on the analysis of data from the medical records of patients participating in DESCAR-T. These analyses are carried out by the LYSARC teams.
The report of this study will be sent to the project leaders, who will only receive descriptive results without individual data. No link can be established between the data contained in the report and the patients whose data are collected in DESCAR-T.
This study “ LBCL 2L axi vs liso ” was initiated in May 2025.
The first results of this study will be presented at an international hematology scientific conference at the end of 2025 and will be used for writing a publication in a scientific medical research journal in 2026.
FOR PATIENTS HAVING RECEIVED CAR-T IN FRANCE
What does this study mean for you?
This study is only for patients participating in DESCAR-T who have large B-cell lymphoma (LBCL) and who have received axi-cel or lisa-cel treatment for their lymphoma as second line of treatment.
If you are in this situation and you agree that your data be 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 DESCAR-T.
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 do not have to do anything
- You wish to object to the use of your data in this study:
⇒ in this case, you must inform the doctor who suggested you participate in the DESCAR-T study. You can also notify your decision by email at : dpo@lysarc.org.
You will find detailed information about your rights to object to the use of your data in the information provided to you when you agreed to participate in DESCAR-T.