Lymphoma Working Party (LWP)
Study type:
Study number:
84032235
Type of treatment:
CAR T
Diseases:
Non-Hodgkin’s Lymphoma (NHL)
Short title:
Axi-cel vs Liso-cel in 2nd line for r/r LBCL
Primary objective:
Comparison of axi-cel and liso-cel as 2nd line therapy in terms of PFS and OS
Key inclusion criteria:
Adult patients with one of the below listed histologic entities who receive
either axi- or liso-cel as 2nd line therapy.
Inclusion period: 01/2022 up to 12/2023
either axi- or liso-cel as 2nd line therapy.
Inclusion period: 01/2022 up to 12/2023
Country:
All EBMT member countries
Principal investigator:
Dr. Anna Ossami SAIDY
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