Lymphoma Working Party (LWP)
Study type:
Study number:
84032246
Type of treatment:
Allogeneic
CAR T
Diseases:
Non-Hodgkin’s Lymphoma (NHL)
Short title:
Consolidative allo-HSCT after CAR-T in lymphoma
Primary objective:
To evaluate outcomes following allogeneic hematopoietic cell
transplantation performed after CAR T-cell therapy in lymphoma patients
without documented disease progression before transplantation.
transplantation performed after CAR T-cell therapy in lymphoma patients
without documented disease progression before transplantation.
Key inclusion criteria:
• Age ≥18 years
• Diagnosis of lymphoma
• Receipt of CAR T-cell therapy
• Subsequent receipt of allo-HCT
• No documented relapse or progression between CAR-T infusion and
allo-HCT (i.e. patient in complete remission, partial remission, or stable
disease after CAR-T)
• Diagnosis of lymphoma
• Receipt of CAR T-cell therapy
• Subsequent receipt of allo-HCT
• No documented relapse or progression between CAR-T infusion and
allo-HCT (i.e. patient in complete remission, partial remission, or stable
disease after CAR-T)
Country:
All EBMT member countries
Principal investigator:
Dr. Remy DULERY
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
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