34
Participants
Start Date
February 15, 2019
Primary Completion Date
July 27, 2021
Study Completion Date
April 26, 2023
Tisagenlecleucel
Tisagenlecleucel was infused once as an intravenous infustion at a dose of either 0.2 to 5 x 106 CAR-positive viable T cells per kg body weight for subjects ≤ 50 kg or 0.1 to 2.5 x 108 CAR-positive viable T cells for subjects \> 50 kg.
lymphodepleting chemotherapy
Prior to tisagenlecleucel infusion, each subject underwent lymphodepletion with recommended Fludarabine and cyclophosphamide (unless contra-indicated for subject)
Bridging Therapy
Pre-treatment phase could also include bridging therapy of investigator's choice
Novartis Investigative Site, Randwick
Novartis Investigative Site, Copenhagen
Novartis Investigative Site, Parkville
Prinses Maxima Centrum voor Kinderoncologie, Utrecht
Memorial Sloan Kettering Cancer Center MSKCC (8), New York
The Childrens Hospital of Philadelphia Drug Shipment, Philadelphia
Novartis Investigative Site, Monza
Johns Hopkins Oncology Center ORA, Baltimore
Novartis Investigative Site, Madrid
Novartis Investigative Site, Münster
Novartis Investigative Site, Paris
University of Texas Southwestern Medical Center ., Dallas
Childrens Hospital Los Angeles, Los Angeles
UCSF Medical Center, San Francisco
Novartis Investigative Site, Villejuif
Dana Farber Cancer Institute Dept.of DFCI, Boston
Cinn Children Hosp Medical Center, Cincinnati
Novartis Investigative Site, Vienna
Novartis Investigative Site, Toronto
Novartis Investigative Site, Helsinki
Novartis Investigative Site, Roma
Kyoto University Hospital, Sakyō-ku
Novartis Investigative Site, Setagaya-ku
Novartis Investigative Site, Oslo
Novartis Investigative Site, Barcelona
Novartis Investigative Site, London
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY