Lymphoma Working Party (LWP)
Study type:
Study number:
84032247
Type of treatment:
Allogeneic
CAR T
Diseases:
Non-Hodgkin’s Lymphoma (NHL)
Short title:
Primary objective:
1. Feasibility and efficacy of brexucel therapy in patients with r/r MCL who
received a prior alloHCT
2. Feasibility and
received a prior alloHCT
2. Feasibility and
Key inclusion criteria:
1) MCL, >= 18y, 1st brexucel therapy between 2016 and 2025, prior alloHCT for MCL
2) MCL, >=18y, 1st alloHCT between 2016 and 2025 after a prior brexucel
treatment.
2) MCL, >=18y, 1st alloHCT between 2016 and 2025 after a prior brexucel
treatment.
Country:
All EBMT member countries
Principal investigator:
Dr. Isabelle Krämer
EBMT Study coordinator:
Irma KHVEDELIDZE
Study coordinator email:
irma.khvedelidze@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
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