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RACE-2: long-term follow-up of patients participating in RACE: the prospective Randomized multicenter study comparing horse Antithymocyte globuline (hATG) + Cyclosporine A (CsA) with or without Eltrombopag as front-line therapy for Severe Aplastic Anemia patients

Severe Aplastic Anaemia Working Party (SAAWP)
Study type:
Non-interventional Prospective Studies
Study number:
84090088
Type of transplant / Cell therapy:
Allogeneic
Diseases:
Bone marrow failure
Short title:
RACE-2: long-term follow-up
Primary objective:
To evaluate the long-term outcome and survival of patients who have received standard IST with or without Eltrombopag within the RACE trial.
Key inclusion criteria:
Subject participated in the RACE trial (EudraCT number: 2014-000363-40) during which patient received ATGAM, Cyclosporine A with or without Eltrombopag.
Country:
France
Italy
Netherlands
Spain
Switzerland
United Kingdom
Principal investigator:
Régis Peffault de Latour, Antonio M. Risitano
EBMT Study coordinator:
Brian Piepenbroek
Study coordinator email:
saawp@ebmt.org
Reason for processing personal data:
Research and Development of new and improved transplant, cell therapy and immunosuppression procedures.
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
3rd-party processors of Personal Data on behalf of EBMT/Service provider:
Non

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