Severe Aplastic Anaemia Working Party (SAAWP)
Study type:
Study number:
84090101
Type of treatment:
Allogeneic
Immunosuppressive Treatment (IST)
Diseases:
Bone marrow failure
Short title:
RACE IST vs HCT
Primary objective:
The main objective is comparing overall survival (OS) and failure-free survival (FFS) of IST, specifically hATG+CsA+EPAG, versus HSCT, possibly considering different donor types, as first-line treatment.
Key inclusion criteria:
Country:
All EBMT member countries
Principal investigator:
Simona Iacobelli, Antonio Risitano
EBMT Study coordinator:
Brian Piepenbroek
Study coordinator email:
saawp@ebmt.org
EBMT Study Unit:
Leiden 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:
Medical data already reported to the EBMT Registry
Study Specific Questionnaire (MED-C)
Recipients who may access the data:
Leiden Study Unit
Statistical Unit
Investigators
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