Cellular Therapy & Immunobiology Working Party (CTIWP)
Study type:
Study number:
8420014
Type of treatment:
CAR T
Diseases:
Acute Lymphatic Leukaemia (ALL)
Non-Hodgkin’s Lymphoma (NHL)
Multiple Myeloma (MM) or other Plasma Cell Disorder (PCD)
Short title:
CAR-T DCI
Primary objective:
The European Medicines Agency (EMA) continues to monitor the safety and effectiveness of Advanced Therapy Medicinal Products (ATMPs) after they are approved and marketed, and may request Marketing Authorisation Holders (MAHs) to conduct an additional post-authorisation safety (PAS) study to monitor the products over a longer period of time.
With the qualification of the Cellular Therapy Form of the EBMT Registry, EMA has recommended MAHs to conduct their PAS study with a 15-years follow-up of patients infused with the Immune Effector Cell (IEC) therapy using the data captured in the EBMT Registry.
This data includes effectiveness data and safety data on adverse events of special interest, as captured on the EBMT Cellular Therapy Form.
These adverse events of special interest are defined by experts in the field in close collaboration with EMA and captured in the standardised data collection forms.
The studies that use the data on CAR-T are stated here :
Yescarta (EUPAS32539):
https://catalogues.ema.europa.eu/node/3104/administrative-details
Kymriah (EUPAS32497):
https://catalogues.ema.europa.eu/node/2692/administrative-details
Abecma (EUPAS45152):
https://catalogues.ema.europa.eu/node/3261/administrative-details
Tecartus (EUPAS45813):
https://catalogues.ema.europa.eu/node/3635/administrative-details
Breyanzi (EUPAS103852):
https://catalogues.ema.europa.eu/node/3676/administrative-details
With the qualification of the Cellular Therapy Form of the EBMT Registry, EMA has recommended MAHs to conduct their PAS study with a 15-years follow-up of patients infused with the Immune Effector Cell (IEC) therapy using the data captured in the EBMT Registry.
This data includes effectiveness data and safety data on adverse events of special interest, as captured on the EBMT Cellular Therapy Form.
These adverse events of special interest are defined by experts in the field in close collaboration with EMA and captured in the standardised data collection forms.
The studies that use the data on CAR-T are stated here :
Yescarta (EUPAS32539):
https://catalogues.ema.europa.eu/node/3104/administrative-details
Kymriah (EUPAS32497):
https://catalogues.ema.europa.eu/node/2692/administrative-details
Abecma (EUPAS45152):
https://catalogues.ema.europa.eu/node/3261/administrative-details
Tecartus (EUPAS45813):
https://catalogues.ema.europa.eu/node/3635/administrative-details
Breyanzi (EUPAS103852):
https://catalogues.ema.europa.eu/node/3676/administrative-details
Key inclusion criteria:
All patients that were treated with a commercial CAR-T, at a site participating in the Data Collection Initiative.
Country:
All European countries
Principal investigator:
EBMT Study coordinator:
EBMT Clinical Study Unit
EBMT Study Unit:
Clinical 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
Centers’ contact / Centers’ policies
Recipients who may access the data:
Leiden Study Unit
Paris Study Unit
Clinical 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
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