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Outcomes after CAR T-cell therapy in Primary Mediastinal B-Cell Lymphoma: a real-world study of the Lymphoma Working Party of the EBMT

Lymphoma Working Party (LWP)
Study type:
Study number:
84032240
Type of treatment:
CAR T
Diseases:
Non-Hodgkin’s Lymphoma (NHL)
Short title:
CAR T for PMBCL
Primary objective:
To evaluate 2-year progression-free survival (PFS) after CD19-directed CAR T-cell therapy in patients with relapsed/refractory PMBCL.
Key inclusion criteria:
- Adults (≥18 years).
- Diagnosis of primary mediastinal B-cell lymphoma.
- Treated with commercial CD19-directed CAR T-cell product (axi-cel, liso-cel, or tisa-cel).
- Treatment between January 2018 and June 2025.
- Sufficient follow-up data available in the EBMT registry.
Country:
All EBMT member countries
Principal investigator:
Dr. Remy DULERY
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