Severe Aplastic Anaemia Working Party (SAAWP)
Study type:
Study number:
84090091
Type of treatment:
Allogeneic - Unrelated
Allogeneic - Haploidentical
Diseases:
Bone marrow failure
Short title:
MMUD vs Haplo for SAA
Primary objective:
The primary objective is to compare 3-year GRFS between MMUD and haploidentical cohorts.
Key inclusion criteria:
The study will analyze all patients with SAA available in the EBMT Registry who underwent a first allogeneic SCT from MMUD and haploidentical donor with post-transplant cyclophosphamide between January 2012 and December 2021). Patients who received in vivo antithymocyte globulin (ATG), Campath, or ex vivo T cell depletion were excluded.
Country:
All EBMT member countries
Principal investigator:
Juan Montoro
EBMT Study coordinator:
Brian Piepenbroek
Study coordinator email:
saawpebmt@lumc.nl
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:
DOB/YOB, gender
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