CART vs AHSCT
Comparative analysis of autologous CD19-targeting CAR T-cell therapy vs Autologous Hematopoietic Stem Cell Transplantation (AHCST) for severe systemic sclerosis: a retrospective cohort study control
Health Data Hub declaration number: pending
Data controller : Assistance publique-Hôpitaux de Paris
Coordinating Investigator : Pr Dominique Farge (Paris Saint-Louis)
Co-coordinating investigator in Erlangen: Pr Christina Bergmann
Principal investigators in Paris : Pr Dominique Farge (Paris Saint-Louis), Dr Zora Marjanovic (Paris Saint-Antoine)
Principal investigator in Haifa: Pr Doron Rimar
Principal investigator in Tubingen: Pr Jörg Henes
Principal investigator in Leiden: Dr Jeska de Vries-Bouwstra
Patient population in France: Systemic sclerosis adult patients treated by autologous hematopoietic stem cell (AHSC) between 2019 and 2024, either at St-Louis or at St-Antoine Hospital (AP-HP), with the following criteria at time of transplant:
- Maximum disease duration before AHSCT : 5 years
- Modified Rodnan skin score (mRSS) ≥ 15 and involvement of heart, lungs or kidneys or disease duration ≤2 years with no major organ involvement but with a mRSS of at least 20 and erythrocyte sedimentation rate (ESR) greater than 25 mm/hr and/or haemoglobin less than 100 g/L,
- Having signed an informed consent for the collection of their medical data in the MATHEC-SFGM-TC registry and the use of these data for research purposes.
Research objective: This research will analyze health data which have been already collected as part of the routine care for Systemic Sclerosis patients while treated with autologous hematopoietic stem cell transplantation (Paris/ Haïfa/Tübingen / Leiden) as compared with similar SSc patients treated with CAR T-cell (Erlangen/Tübingen/Haïfa). These data have already been collected in the MATHEC-SFGM-TC registry or in the Haifa/ Tübingen / Erlanger/Leiden registries, with the written informed consent of the relevant patients. The aim of this retrospective data analysis is to compare safety and efficacy data from SSc patients treated by CD-19 CAR-T (cases) and by AHSCT (controls).
Information for patients included in the study in France: In accordance with the informed consent previously signed by each patient, their agreement has been obtained for the use of their data for research purposes.
Right for opposition:
Patients may contact the study coordinating investigator or a team member to apply their right to be opposed to this study:
– By email at the following address: dominique.farge-bancel@aphp.fr; ingrid.munia@aphp.fr
– By telephone at +33 (0)142385093
– By post at the following address: Unité de Médecine Interne (UF 04): CRMR MATHEC, Maladies Auto-immunes et Thérapie Cellulaire, Hôpital Saint-Louis, 1 avenue Claude Vellefaux, 75010 Paris, France.
Should you encounter any difficulties in exercising your rights, please contact the AP-HP Data Protection Officer at the following address: protection.donnees.dsi@aphp.fr
