Infectious Diseases Working Party (IDWP)
Study type:
Study number:
84140165; 84140166; 84140167
Type of treatment:
Allogeneic
Autologous
Diseases:
Complications: infectious
Short title:
IFI after allo and auto HCT
Primary objective:
Key inclusion criteria:
Inclusion criteria:
• Patient registered in the EBMT Registry
• Allogeneic or autologous HCT performed between 1 January 2015 and 30 July 2026
• Any age
• Any underlying disease
• Relevant IFI occurring after an allogeneic or autologous HCT
• Availability of clinical and microbiological data on the relevant IFI
Exclusion criteria:
• CAR-T patients
• Lack of confirmatory microbiological data
• Patient registered in the EBMT Registry
• Allogeneic or autologous HCT performed between 1 January 2015 and 30 July 2026
• Any age
• Any underlying disease
• Relevant IFI occurring after an allogeneic or autologous HCT
• Availability of clinical and microbiological data on the relevant IFI
Exclusion criteria:
• CAR-T patients
• Lack of confirmatory microbiological data
Country:
All EBMT member countries
Principal investigator:
Simone Cesaro & Maria Pia Esposto, Aliénor Xhaard & Silvia Corcione, Malgorzata Mikulska & Claudia Bartalucci
EBMT Study coordinator:
Nina Knelange, Lotus Wendel
Study coordinator email:
idwp@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.
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
Study Specific Questionnaire (MED-C)
Recipients who may access the data:
Leiden Study Unit
Statistical Unit
Investigators
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