Paediatric Diseases Working Party (PDWP)
Study type:
Study number:
Type of Stem Cell Treatment:
Allogeneic
Allogeneic - Related
Allogeneic - Unrelated
Allogeneic - Haploidentical
Diseases:
Acute Myeloid Leukaemia (AML)
Short title:
Primary objective:
The aim is to evaluate the variables impacting the occurrence of aGVHD III-IV. The second aim is to evaluate the impact of aGVH occurrence in other outcome (as landmark analaysis).
Key inclusion criteria:
Country:
All EBMT member countries
Principal investigator:
Giovanna Lucchini
EBMT Study coordinator:
Arnaud Dalissier
Study coordinator email:
arnaud.dalissier@upmc.fr
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.
Research and Development of new and improved transplant, cell therapy and immunosuppression procedures.
Categories of personal data collected:
DOB/YOB, gender
Medical data already reported to the EBMT Registry
Recipients who may access the data:
Paris 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)
Is a Data Protection Impact Assessment required?:
DPIA performed for EBMT Registry (WP & NIS Studies)
Retention Schedule (if possible):
at least 15 years after completion or discontinuation of the study (WP/NIS)