A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel versus Standard of Care Therapy in Subjects with Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)

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Study title: 
A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel versus Standard of Care Therapy in Subjects with Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)
Date receipt dossier: 
25 Apr 2018
EudraCT number: 
2017-002261-22
Company / Sponsor: 
Kite Pharma
Phase: 
III
Treated organism: 
Humans
Indication category: 
Cancer therapy
Disease: 
B cell malignancies
Therapeutic approach: 
Immunotherapy
Genetic modification: 
Chimeric antigen receptor against CD19
Method of transfer of nucleic acid of interest: 
Retroviral vectors
Administered biological material: 
Autologous T cells transduced with retroviral vectors (YESCARTA, Axicabtagene ciloleucel)
Route of administration: 
Intravenous
Locations in Belgium: 
UCL (Hôpital Saint-Luc)
Nr of subjects: 
6
Type of procedure: 
Contained use only
Current status: 
Authorized