Frequency and Impact of Pre-Transplant Somatic Co-Occurring Mutations on Clinical Outcomes of Acute Myeloid Leukemia Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation: On Behalf of the EBMT Acute Leukemia Working Party

Study type:

Retrospective Studies

Study number:

Type of Stem Cell Treatment:

Allogeneic

Diseases:

Acute Myeloid Leukaemia (AML)

Short title:

Primary objective:

Key inclusion criteria:

Country:

All EBMT member countries

Principal investigator:

Ali Bazarbachi

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:

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