A phase II, single-arm, multi-center trial to determine the efficacy and safety of CTL019 in pediatric patients with relapsed and refractory B-cell acute lymphoblastic leukemia

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Study title: 
A phase II, single-arm, multi-center trial to determine the efficacy and safety of CTL019 in pediatric patients with relapsed and refractory B-cell acute lymphoblastic leukemia
Date receipt dossier: 
14 okt 2015
EudraCT number: 
2014-003060-20
Company / Sponsor: 
Novartis Pharma Services AG
Phase: 
II
Treated organism: 
Humans
Indication category: 
Cancer therapy
Disease: 
Leukemia
Therapeutic approach: 
Immunotherapy
Genetic modification: 
Chimeric antigen receptor against CD19
Method of transfer of nucleic acid of interest: 
Lentiviral vector
Administered biological material: 
T-cells transduced with lentiviral vector expressing anti-CD19 CAR
Route of administration: 
Intravenous
Locations in Belgium: 
UZ Gent
Type of procedure: 
Contained use only
Current status: 
Authorized