Infectious Diseases Working Party (IDWP)
Study type:
Study number:
84140150
Type of treatment:
Allogeneic
Autologous
Diseases:
All diseases
Short title:
HCT in HIV+ patients
Primary objective:
The first part will compare the 100-day non-relapse mortality (NRM) between HIV-positive and HIV-negative transplant patients using data from the EBMT registry.
For the second part, additional data will be collected for HIV-positive transplant patients to describe transplant characteristics, the infectious complications probability and 1-year follow-up outcome data.
For the second part, additional data will be collected for HIV-positive transplant patients to describe transplant characteristics, the infectious complications probability and 1-year follow-up outcome data.
Key inclusion criteria:
Cases must meet the following criteria:
• Data available in the EBMT Registry
• ≥18 years
• HIV-positive before the start of conditioning
• First autologous or allogeneic HCT between 1 January 2010 and 31 July 2023
• Any underlying disease
• Known whether the patient is alive or not at minimum 100 days after the day of HCT
If the centres that provided the HIV-cases can confirm that all other patients transplanted at their centre in the study period were HIV-negative, each of these patients who were ≥18 years and received their first autologous or allogeneic HCT in the defined study period will be included in the control group.
Controls must meet the following criteria:
• Data available in the EBMT Registry
• Transplanted at one of the centres that provided HIV-cases
• ≥18 years
• HIV-negative at the start of conditioning
• First autologous or allogeneic HCT between 1 January 2010 and 31 July 2023
• Known whether the patient is alive or not at minimum 100 days after the day of HCT
• Data available in the EBMT Registry
• ≥18 years
• HIV-positive before the start of conditioning
• First autologous or allogeneic HCT between 1 January 2010 and 31 July 2023
• Any underlying disease
• Known whether the patient is alive or not at minimum 100 days after the day of HCT
If the centres that provided the HIV-cases can confirm that all other patients transplanted at their centre in the study period were HIV-negative, each of these patients who were ≥18 years and received their first autologous or allogeneic HCT in the defined study period will be included in the control group.
Controls must meet the following criteria:
• Data available in the EBMT Registry
• Transplanted at one of the centres that provided HIV-cases
• ≥18 years
• HIV-negative at the start of conditioning
• First autologous or allogeneic HCT between 1 January 2010 and 31 July 2023
• Known whether the patient is alive or not at minimum 100 days after the day of HCT
Country:
All EBMT member countries
Principal investigator:
Annalisa Paviglianiti
EBMT Study coordinator:
Inge Verheggen
Study coordinator email:
idwp@ebmt.org
EBMT Study Unit:
Leiden Study Unit
Reason for processing personal data:
Research and Development of new and improved transplant, cell therapy and immunosuppression procedures.
Categories of personal data collected:
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