Severe Aplastic Anaemia Working Party (SAAWP)
Study type:
Study number:
84090092
Type of Stem Cell Treatment:
Allogeneic
Diseases:
Bone marrow failure
Short title:
PTCy TX in SAA
Primary objective:
The primary objective is to compare 2-year GRFS between cohorts.
Key inclusion criteria:
The study will analyze all patients with aplastic anemia available in the EBMT registry who underwent a first allogeneic SCT, from an unmanipulated graft, using PTCy from haplo, MUD, MMUD, or MSD donors between 01/01/2010 and 31/12/2021. Haplo is defined as recipient-donor number of human leukocyte antigen (HLA) mismatches ≥ 2.
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
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