Paediatric Diseases Working Party (PDWP)
Study type:
Study number:
8417052
Type of treatment:
Allogeneic - Haploidentical
Diseases:
Acute Lymphatic Leukaemia (ALL)
Acute Myeloid Leukaemia (AML)
Short title:
Primary objective:
To compare leukemia-free survival outcomes between TCR αβ/CD19+depleted or PTCY approach approaches in pediatric HLA-haploidentical transplants.
Key inclusion criteria:
1) First allogeneic HCT for acute lymphoblastic (ALL) or AML, including therapy related leukemia.
2) Haploidentical related donor with TCR αβ/CD19+depleted or PTCY approach
3) Age < 18 years at HCT
4) Year of Transplant: 01/2010-12/2022
5) First allo HSCT(no previous auto or allo)
2) Haploidentical related donor with TCR αβ/CD19+depleted or PTCY approach
3) Age < 18 years at HCT
4) Year of Transplant: 01/2010-12/2022
5) First allo HSCT(no previous auto or allo)
Country:
All EBMT member countries
Principal investigator:
Franco Locatelli
EBMT Study coordinator:
Arnaud Dalissier
Study coordinator email:
arnaud.dalissier@ebmt.org
EBMT Study Unit:
Paris 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
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)
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