Cellular Therapy & Immunobiology Working Party (CTIWP)
Study type:
Study number:
Type of Stem Cell Treatment:
Cellular therapies (other than DLI)
Diseases:
Acute Lymphatic Leukaemia (ALL)
Non-Hodgkin’s Lymphoma (NHL)
Multiple Myeloma (MM) or other Plasma Cell Disorder (PCD)
Short title:
Data collection initiative on CART
Primary objective:
The EMA continues to monitor the safety and efficacy of ATMPs after they are approved and marketed,
and may request MAHs to conduct an additional post-authorisation study (PAS) to monitor the products
over a longer period of time. With the qualification of the Cellular and Gene Therapy module Form of the
EBMT Registry, the EMA has recommended MAHs to conduct their PAS with a 15 -years follow -up of patients
infused with period from the IEC therapy using the data captured in the EBMT Registry. This data includes
efficacy data and safety data on adverse events which are of special interest, as captured on the EBMT Cellular
and Gene Therapy Form. These adverse events of special interest are defined a priori by experts in the field in
close collaboration with the EMA and captured in the standardised data collection forms.
The studies that use the data on CART are stated here :
EUPAS32539: http://www.encepp.eu/encepp/viewResource.htm?id=37249
EUPAS32497: http://www.encepp.eu/encepp/viewResource.htm?id=35597
EUPAS45152: https://www.encepp.eu/encepp/viewResource.htm?id=45153
EUPAS45813: https://www.encepp.eu/encepp/viewResource.htm?id=50709
EUPAS103852: https://www.encepp.eu/encepp/viewResource.htm?id=103853
and may request MAHs to conduct an additional post-authorisation study (PAS) to monitor the products
over a longer period of time. With the qualification of the Cellular and Gene Therapy module Form of the
EBMT Registry, the EMA has recommended MAHs to conduct their PAS with a 15 -years follow -up of patients
infused with period from the IEC therapy using the data captured in the EBMT Registry. This data includes
efficacy data and safety data on adverse events which are of special interest, as captured on the EBMT Cellular
and Gene Therapy Form. These adverse events of special interest are defined a priori by experts in the field in
close collaboration with the EMA and captured in the standardised data collection forms.
The studies that use the data on CART are stated here :
EUPAS32539: http://www.encepp.eu/encepp/viewResource.htm?id=37249
EUPAS32497: http://www.encepp.eu/encepp/viewResource.htm?id=35597
EUPAS45152: https://www.encepp.eu/encepp/viewResource.htm?id=45153
EUPAS45813: https://www.encepp.eu/encepp/viewResource.htm?id=50709
EUPAS103852: https://www.encepp.eu/encepp/viewResource.htm?id=103853
Key inclusion criteria:
All patients that were treated with a commercial CART.
Country:
All European countries
Principal investigator:
EBMT Study coordinator:
EBMT Clinical Study Unit
Study coordinator email:
EBMT_NK01@lumc.nl
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
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)
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