GoCART Coalition
Autoimmune Diseases Working Party (ADWP)
Cellular Therapy & Immunobiology Working Party (CTIWP)
Transplant Complications Working Party (TCWP)
Study type:
Study number:
Type of Stem Cell Treatment:
CAR T
Diseases:
Acute Lymphatic Leukaemia (ALL)
Multiple Myeloma (MM) or other Plasma Cell Disorder (PCD)
Non-Hodgkin’s Lymphoma (NHL)
Short title:
sHLH/MAS
Primary objective:
Primary Aim: To estimate the cumulative incidence of sHLH/MAS (macrophage activating syndrome) post CAR-T cell therapy
Secondary Aims:
1. To describe the parameters used for diagnosis and treatment of patients who developed sHLH/MAS
2. To estimate the cumulative incidence of confirmed autoimmune cytopenia post CAR-T cell therapy
3. To estimate OS, PFS, RI and NRM post CAR-T cell therapy
Secondary Aims:
1. To describe the parameters used for diagnosis and treatment of patients who developed sHLH/MAS
2. To estimate the cumulative incidence of confirmed autoimmune cytopenia post CAR-T cell therapy
3. To estimate OS, PFS, RI and NRM post CAR-T cell therapy
Key inclusion criteria:
First chronological CAR-T
CART received between 2015 and 2022
Diagnosis of acute leukemia, plasma cell disorders and lymphoma
CART received between 2015 and 2022
Diagnosis of acute leukemia, plasma cell disorders and lymphoma
Country:
All EBMT member countries
Principal investigator:
Matteo Doglio
EBMT Study coordinator:
Eva MICHEL
Study coordinator email:
eva.michel@ebmt.org
EBMT Study Unit:
Paris Study Unit
Reason for processing personal data:
Research and Development of new and improved transplant, cell therapy and immunosuppression procedures.
Categories of personal data collected:
DOB/YOB, gender
Medical data already reported to the EBMT Registry
Study Specific Questionnaire (MED-C)
Recipients who may access the data:
Paris Study Unit
3rd-party processors of Personal Data on behalf of EBMT/Service provider:
No
Privacy notices
Article 6 lawful basis for processing personal data:
Article 6.1 (a) - Consent (Collection)
Article 9 basis for processing special category data:
Article 9(2) (a) - Consent (Collection)
Data Protection Impact Assessments
Rights available to individuals:
Access
Data portability
Rectification
Objection
Deletion
Is a Data Protection Impact Assessment required?:
DPIA performed for EBMT Registry (WP & NIS Studies)
Retention Schedule (if possible):
at least 5 years after the final report or first publication of study results