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Data collection initiative on CART

Cellular Therapy & Immunobiology Working Party (CTIWP)
Study number:
 
Short title:
Data collection initiative on CART
Study status:
Recruiting
Deadline for data collection:
Study design:
Non interventional
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.

Two 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
Key inclusion criteria:
All patients that were treated with a commercial CART.
Country:
 
Principal investigator:
 
Principal investigator email:
 
EBMT Study coordinator:
EBMT Clinical Study Unit
Study coordinator email:
EBMT_NK01@lumc.nl