The DESCAR-T registry was set up at the request of the health authorities to improve knowledge of chimeric antigen receptor T cell (CAR-T) therapies marketed in France to treat patients diagnosed with hematologic 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.
With the data collected, the registry allows for research projects to answer specific research questions. One of these projects is looking at acute toxicities following the injection of CAR-T cells that require the use of organ suppleance (e.g., an artificial ventilator if the lungs have difficulty functioning).
Why is this analysis being implemented?
CAR-T cells can sometimes cause rapid and severe reactions (acute toxicity) that can impact the proper functioning of certain organs. It is sometimes necessary to be transferred to the intensive care unit to be able to compensate for these organs with machines, while they recover. For example, the work of the kidneys can be compensated by dialysis, or the lungs can be supported by an artificial respirator.
This analysis will provide additional information on these specific CAR-T toxicities in several medical disciplines, particularly in hematology and intensive care medicine, involved in the management of patients receiving these therapies.
What are the objectives of the analysis?
Early data suggest that these initial toxicities are not related to the efficacy of CAR-T cells. The first objective of this analysis is to look at the impact of the occurrence of these toxicities on patients’ life expectancy in real life, on a large cohort of patients in France.
This analysis also aims to describe the care needed by patients who are affected by these toxicities: their severity, the type of organ suppleance needed, how long patients stay in intensive care, etc., in order to be able to inform the medical team of the various hospital departments concerned.
Another objective of this analysis is to look for the factors that could promote the occurrence of these toxicities, such as the subtype of cancer or the age of the patients, to identify the patients most at risk in order to be able to adapt their medical care.
How will the analysis be carried out?
This project requires data that is not yet available in the DESCAR-T registry database. This data exists in your medical file but also in the national databases that allow the reimbursement of care provided in hospitals (the PMSI via the SNDS portal: in other words, the Hospital discharge summaries database via the portal of the National Health Data System).
An indirect match between patients included in DESCAR-T and patients who have been hospitalized (whose care is recorded in the PMSI) will be performed to meet the scientific objectives of this study. In other words, for each patient participating in DESCAR-T, we will try to associate their data from the PMSI database (SNDS portal) using data relating to their age, sex, diagnosis, dates and types of care received to identify them. This is called indirect matching because there is no unique patient identifier present in both databases. The data in DESCAR-T and PMSI are associated with pseudonyms that do not directly identify a patient.
In addition, no data from the PMSI can be recorded in DESCAR-T. The PMSI data used for this study will remain on a secure server (SNDS portal) and will only be used to meet the objectives presented above. Working on this database allows to obtain information more quickly and comprehensively.
Statistical analyses on the matched DESCAR-T and PMSI data will be carried out by a biostatistician from the “Health Data Science” unit of the Public Health Department of the Montpellier University Hospital. This person is certified by the Registration Authority of the Montpellier University Hospital for the SNDS to work on the data from these national databases.
This analysis is led by Dr. Jean-Jacques Tudesq, a doctor specializing in Hematological Intensive Care at the Montpellier University Hospital and Simon Menez, an intern in intensive care medicine at the Rennes University Hospital. The teams from the Montpellier University Hospital, LYSARC and IFM will work together with the scientific leaders of this study on the analyses to be carried out.
FOR PATIENTS WHO HAVE RECEIVED CAR-T THERAPY IN FRANCE
What does this project mean for you?
This project concerns adult patients included in the DESCAR-T registry, diagnosed with Lymphoma, Multiple myeloma or acute lymphoblastic leukemia who received a CAR T-cell therapy (outside clinical trials) in France.
If you are in this situation and agree for your data to be used for this project, it does not require any direct involvement on your part. The data already exist in the various registers mentioned.
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 study,
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“