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Impact of fludarabine dose modification in conditioning regimen for CAR T-cell therapy

Cellular Therapy & Immunobiology Working Party (CTIWP)
Study type:
Study number:
 
Type of treatment:
CAR T
Diseases:
Non-Hodgkin’s Lymphoma (NHL)
Acute Lymphatic Leukaemia (ALL)
Short title:
FluCar
Primary objective:
 
Key inclusion criteria:
 
Country:
All EBMT member countries
Principal investigator:
Guillaume Dachy
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:
Leiden 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