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Retrospective analysis of different rabbit ATG brands on outcome and occurrence of acute and chronic GVHD in patients with aplastische anemia undergoing allogeneic transplantation

Severe Aplastic Anaemia Working Party (SAAWP)
Study type:
Retrospective Studies
Study number:
84090097
Type of treatment:
Allogeneic
Allogeneic - Related
Allogeneic - Unrelated
Diseases:
Bone marrow failure
Short title:
ATG brands in AA
Primary objective:
Our main objective is to assess the overall survival in patients diagnosed with aplastic anemia receiving different brands of rabbit ATG (Grafalone and Thymoglobuline) for allogeneic stem cell transplantation from a matched sibling and matched unrelated donor in European centres.
Key inclusion criteria:
• Diagnosis of acquired severe or very severe aplastic anemia
• allogeneic transplantation from a matched sibling and matched unrelated donor
• Patients of all ages
• Treatment with rabbit ATG as part of the conditioning regimen
Country:
All EBMT member countries
Principal investigator:
Fabian Beier
EBMT Study coordinator:
Joe Tuffnell
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
Recipients who may access the data:
Leiden Study Unit
Statistical 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