Study of the efficacy and safety of Axi-cel (CAR-T cells) in second line versus later-line treatment in patients enrolled in the DESCAR-T registry with large B-cell lymphoma.

The DESCAR-T registry was set up at the request of the health authorities to improve knowledge of CAR-T cell therapies marketed in France to treat patients with hematologic malignancies. The aim of this registry is to support data on the short- and long-term efficacy and tolerability of these treatments in real life.

Thanks to the data collected, the registry makes it possible to carry out projects to answer specific research questions. One of these projects is interested in comparing the efficacy and safety of Axi-cel (CAR-T cell therapy) in second line versus later-line treatment in patients enrolled in the DESCAR-T registry with large B-cell lymphoma.

Why is this study being implemented?

The DESCAR-T registry was set up at the request of the health authorities to improve knowledge of CAR-T cell therapies marketed in France to treat patients with hematologic malignancies. The aim of this registry is to support data on the short- and long-term efficacy and tolerability of these treatments in real life.

Thanks to the data collected, the registry makes it possible to carry out projects to answer specific research questions. One of these projects is interested in comparing the efficacy and safety of Axi-cel (CAR-T cell therapy) in second line versus later-line treatment in patients enrolled in the DESCAR-T registry with large B-cell lymphoma.

What are the objectives of the study?

There are three objectives:

The first objective is to compare the effectiveness of the treatment according to when it is used (2nd line or later), looking at whether the disease responds, disappears completely, how long it remains controlled and overall survival.

The second objective is to compare the side effects of treatment according to when it is used, assessing possible short-term complications (such as inflammatory reactions, neurological disorders or ICU visits) and possible long-term effects.

How will the study be carried out?

This study will be based on the analysis of data from the medical records of patients with large B-cell lymphoma who used Axi-cel (CAR-T cells) and participated in DESCAR-T.

This study is carried out by Dr. Jean LEMOINE, physician at the Saint-Louis Hospital (Assistance Publique & Hôpitaux de Paris (APHP)) in Paris, France and Dr. Guillaume Manson of the Rennes University Hospital.

The statistical analysis will be carried out by Dr. LEMOINE who will have access to data on all patients with large B-cell lymphoma who participate in the DESCAR-T study. This data will not make it possible to establish a link with the identity of the patients because it is pseudonymized: the first and last names of each person are replaced by a unique number assigned when they are included in DESCAR-T. LYSARC and its partners cannot link this number to a patient’s identity.

The study is scheduled to begin in June 2026.

ATTENTION  TO PATIENTS PARTICIPATING  IN DESCART-T 

What does this study mean for you?

This study is only for patients participating in DESCAR-T who have large B-cell lymphoma and who have received Axi-cel (CAR-T cells) for their lymphoma.

If you are in this situation and you agree to have your data used for this study, it has no direct implications for you.

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:

  • There are two options:
    1. You are not opposed to the use of your data in the context of this study:
      1. In this case, you don’t have to do anything
    2. You wish to object to the use of your data in the context of this study:
      1. In this case, you must inform the doctor who offered to participate in the DESCAR-T study. You can also notify your decision by writing an email to the following address: dpo@lysarc.org.

    You will find precise information on your rights to object to the use of your data in the information note that was given to you when you agreed to participate in DESCAR-T.