TRANSCAR : Comparison of the efficacy and safety of CAR-T in “de novo” DLBCL VS transformed indolent lymphoma (tNHL)

The DESCAR-T registry was set up at the request of the health authorities to improve our knowledge of CAR T-cell therapies marketed in France to treat patients diagnosed with hematological malignancies. The objective of this registry is to collect data on the efficacy as well as on short- and long-term tolerance of these therapies in real-life setting.

Using the registry data, research projects to answer specific questions can be undertaken. One of these projects aims to better understand the efficacy and safety of CAR-T cells in patients diagnosed with transformed indolent Diffuse Large B-Cell Lymphoma (DLBCL) after at least two previous lines of cancer treatment.

Why is this study being implemented?

Diffuse large B-cell lymphoma is the most common type of non-Hodgkin lymphoma. This lymphoma can be either secondary, that means it occurs during the progression of another type of lymphoma (indolent lymphoma), or called “de novo”, that means it is diagnosed on a biopsy, most often lymph node, without known history of lymphoma.

CAR-T cells have shown impressive results in the treatment of relapsed or refractory DLBCL. However, patients with transformed indolent lymphoma were very poorly represented in these early results.

Analyses of data from the DESCART registry have previously shown that patients with indolent transformed DLBCL have significantly better outcomes than patients with aggressive de novo DLBCL. This project aims to provide the medical and scientific community with additional knowledge to better understand the efficacy and safety of CAR-T cell therapies in real-life in the case of transformed indolent lymphomas.

What are the objectives of the study?

The study aims to compare the efficacy and safety of CAR-T cells in patients with transformed indolent lymphoma versus patients with de novo DLBCL in a large multicenter real-life cohort.

 

How will the study be carried out?

This project is led by Julien Calvany (intern) and Dr. Pierre Stephan at the Saint Louis Hospital of the Assistance Publique des Hôpitaux de Paris, and Dr. Pierre Sesques, hematologist at the Lyon Sud University Hospital.

The study will be based on the analysis of data from the DESCAR-T registry and additional work to validate the medical diagnoses of patients by the project leaders. The data used in this project does not allow LYSARC and the researchers to link it to the identity of the patients because it is pseudonymized: a unique number is associated with each patient when included in the registry.

This study started in December 2023 and the results were presented orally at the European Association of Hematology (EHA) congress in June 2024. They will be the subject of a scientific publication in a medical research journal in 2025.

FOR PATIENTS WHO HAVE BEEN OFFERED CAR-T THERAPY IN FRANCE

What does this project mean for you?

This project concerns patients included in the DESCAR-T registry, diagnosed with diffuse large B−cell lymphoma, for whom CAR T-cell therapy has been considered (outside clinical trials) in France.

If you are in this situation and agree for your data to be used for this project, this has no direct implications for you.

What should you do about this study?

  • If you would like more information about the processing of your data in the context of DESCAR-T and this project,
  • or if you wish to exercise your rights regarding your data (access and rectification, limitation of their use),

   inform the doctor at your hospital or centre of care for CAR T-cell therapy,  who will contact LYSARC while maintaining your anonymity. You can also notify your decision by email at: dpo@lysarc.org.

Otherwise, you don’t have to do anything.

You can find more information about your rights in relation to your data “I am participating or have participated in a trial“.