Paediatric Diseases Working Party (PDWP)
Study type:
Study number:
8417043
Type of Stem Cell Treatment:
Allogeneic
Diseases:
Acute Lymphatic Leukaemia (ALL)
Short title:
Primary objective:
Primary Aim: to compare the incidence of secondary malignancies in patients with ALL aged 2-4 years receiving either TBI or chemo based conditioning and transplanted in the years 2000-2012
Secondary Aim: to analyse the main standard outcome parameters according to the two different conditioning strategies
Secondary Aim: to analyse the main standard outcome parameters according to the two different conditioning strategies
Key inclusion criteria:
1) Patients age 2-4 years at first transplant
2) Patients diagnosed as ALL
3) Complete Remission 1 or 2 at transplant
4) Patient who underwent a first allograft between 2000 and 2012 included
2) Patients diagnosed as ALL
3) Complete Remission 1 or 2 at transplant
4) Patient who underwent a first allograft between 2000 and 2012 included
Country:
All EBMT member countries
Principal investigator:
Krzysztof Kalwak
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.
Categories of personal data collected:
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