Lymphoma Working Party (LWP)
Study type:
Study number:
84032102
Type of treatment:
Autologous
Diseases:
Hodgkin’s Disease (HD)
Short title:
NIS BV or CPI as bridge to auto SCT in HL
Primary objective:
To assess the real-world impact of the use of BV and/or CPI-based salvage therapy as bridge to autologous SCT for HL.
Key inclusion criteria:
Adults (patients ≥ 18 years of age) with a diagnosis
of classical Hodgkin lymphoma and a decision to use Brentuximab Vedotin
and/or Checkpoint inhibitors as bridge to autologous stem cell
transplantation.
of classical Hodgkin lymphoma and a decision to use Brentuximab Vedotin
and/or Checkpoint inhibitors as bridge to autologous stem cell
transplantation.
Country:
All EBMT member countries
Principal investigator:
Dr. Ali BAZARBACHI & Dr. Anna SUREDA
EBMT Study coordinator:
Diane Marie BACABAC
Study coordinator email:
diane.bacabac@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:
DOB/YOB, gender
Medical data already reported to the EBMT Registry
Study Specific Questionnaire (MED-C)
Recipients who may access the data:
Paris Study Unit
Statistical 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