Transplant Complications Working Party (TCWP)
Study type:
Study number:
Type of treatment:
CAR T
Diseases:
All diseases
Short title:
NRM post CAR-T
Primary objective:
Identify the risk of non-relapse mortality after different CAR T cell products, for each indication
Key inclusion criteria:
1. CAR-Ts infused before 01/01/2024
2. Patients receiving a licensed CAR-T cell product
3. First CAR-Ts only
4. All diagnoses (acute leukemia, lymphoma, multiple myeloma)
5. Adults at time of CAR-T infusion
2. Patients receiving a licensed CAR-T cell product
3. First CAR-Ts only
4. All diagnoses (acute leukemia, lymphoma, multiple myeloma)
5. Adults at time of CAR-T infusion
Country:
All EBMT member countries
Principal investigator:
Charlotte Graham
EBMT Study coordinator:
William Boreland
Study coordinator email:
tcwp@ebmt.org
EBMT Study Unit:
Paris Study Unit
Reason for processing personal data:
Patients’ data is needed to be able to identify the patient and calculate age at any time (impact on SAEs and response to clinical medications). Health care personal data is part of the CV collected for evidence of proper qualification for running the trial.
Categories of personal data collected:
DOB/YOB, gender
Medical data already reported to the EBMT Registry
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