The DESCAR-T registry has been created at the request of the French Health Authorities to collect data in order to consolidate the knowledge on the efficacy and safety at both short- and long-term of all CAR-T cell therapies marketed in France.
MILTENYI Biomedicine is a biopharmaceutical company dedicated to bringing accessible and innovative cancer treatments and regenerative therapies to patients. MILTENYI Biomedicine’s clinical research activities are currently focusing on difficult-to-treat haematological cancers using CAR-T technology.
MILTENYI Biomedicine contacted the LYSARC to carry out a project with the DESCAR-T registry. The objective is to compare the results of one of its ongoing studies (on the use of one of Miltenyi’s CAR T-cell therapy in development for the treatment of patients diagnosed with diffuse large B-cell lymphomas (DLBCL)) with the results of the other CAR-T received by a comparable patient population in DESCAR-T (with no differentiation by CAR-T therapy). This comparison population is identified using several criteria, including the age or the patient general status at the time of the CAR-T prescription. This technic creates what is called a “synthetic control arm”.
A first phase of the project aims to analyse the efficacy and safety of CAR T-cell treatment in all patients diagnosed with a DLBCL and a subpopulation with a less favourable prognosis, included in the DESCAR-T registry. At this stage, no comparison is made with the CAR-T cells being developed by Miltenyi.
The LYSARC will perform the data analysis and the laboratory will only receive descriptive reports, where results are anonymised (i.e. there is no possibility to identify any patient from the information in the report).
The analyses for this project will be made on the data of patients diagnosed with DLBCL and treated by CAR T-cells between July 2018 and October 2021
To the patients in the DESCAR-T registry, and more particularly those diagnosed with DLBCL: if you wish to object to the use of your data for this analysis, you can contact the doctor at your care centre for your treatment by CAR T-cells or make a request at dpo@lysarc.org. You can find more details on your rights regarding your data in the section “I am participating or have participated in a clinical trial“, or in the Patient Information Leaflet you received at the time of your inclusion in the DESCAR-T registry.