Cellular Therapy & Immunobiology Working Party (CTIWP)
Type d'étude:
Numéro de l'étude:
Type de traitement à base de cellules souches:
Cellular therapies (other than DLI)
Maladies:
Acute Lymphatic Leukaemia (ALL)
Non-Hodgkin’s Lymphoma (NHL)
Multiple Myeloma (MM) or other Plasma Cell Disorder (PCD)
Titre court:
Data collection initiative on CART
Objectif principal:
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
Principaux critères d'inclusion:
All patients that were treated with a commercial CART.
Pays:
Tous les pays européens
Investigateur principal:
Coordinateur EBMT de l'étude:
EBMT Clinical Study Unit
E-mail du coordinateur de l'étude:
EBMT_NK01@lumc.nl
Unité d'étude EBMT:
Unité d'études cliniques
Raison du traitement des données personnelles:
Les données des patients sont nécessaires pour pouvoir identifier le patient et calculer son âge à tout moment (impact sur les EIG et réponse aux médicaments cliniques). Les données personnelles sur les soins de santé font partie du CV collecté pour prouver la qualification appropriée pour la conduite de l'essai.
Catégories de données personnelles collectées:
Date de Naissance / Année de Naissance, Genre
Données médicales déjà déclarées au registre EBMT
Contact des centres / Politiques des centres
Destinataires pouvant accéder aux données:
Unité d'études de Leiden
Unité d'études de Paris
Unité d'études cliniques
Unité statistique
Sous-traitants tiers de données personnelles pour le compte de l'EBMT/Prestataire de services:
Oui
Privacy notices
Article 6 base légale pour le traitement des données personnelles:
Article 6.1 (a) - Consentement (Collecte)
Base de l'article 9 pour le traitement des données de catégorie spéciale:
Article 9(2) (a) - Consentement (Collecte)
Une évaluation de l'impact (DPIA) sur la protection des données est-elle requise ?:
Analyse d'impact réalisée pour le registre EBMT (études WP & NIS)
Calendrier de conservation (si possible):
Au moins 5 ans après le rapport final ou la première publication des résultats de l'étude