Infectious complications following CAR T-Cells injection

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.

Thanks to the data collected, the registry makes it possible to carry out projects to answer specific research questions. One of these projects focuses on infectious complications following CAR-T injection.

Why is this study being implemented?

CAR-T cells are innovative therapies that have been offered to certain patients with lymphomas for more than five years now. Despite this, there is a lack of data describing the infectious complications of CAR T-cells, their frequency and their contributing factors, in the short, medium and long term, at the international and French levels. The DESCAR-T registry offers the possibility of a detailed real-life description of a large cohort of patients.

What are the objectives of the study?

The study firstly aims to describe the infectious complications (bacterial, viral, parasitic and fungal) presented by patients following their injection with CAR T cells. Its second objective is to identify factors that promote their appearance.

This study will provide the scientific and medical community with the keys to a better patient management.

How will the study be carried out?

This study is led by Tiy MORRIS (infectious diseases medical intern) and Dr. Ludovic FOUILLET, (hematologist) at the Saint-Etienne University Hospital.

The study will be based on the analysis of data from the DESCAR-T register. The analysis will be carried out by the LYSARC team. 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 is collected in DESCAR-T.

This study will be carried out in the second half of 2024 for the project leader medicine thesis. The results are also expected to be reported at international lymphoma congresses and as a scientific paper 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 who have presented an infection following their CAR-T injection (outside of clinical trials).

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“.