115
Participants
Start Date
July 29, 2015
Primary Completion Date
December 22, 2022
Study Completion Date
December 22, 2022
Tisagenlecleucel
The target dose of CTL019 transduced cells for adult patients consisted of a single infusion of 5 x 10\^8 viable CTL019 transduced cells, which was administered via intravenous infusion. The acceptable dose range was 1 - 5x10\^8 viable CTL019 transduced cells.
Lymphodepleting chemotherapy
Prior to CTL019 cell infusion, an additional lymphodepleting chemotherapy cycle was planned. The use of any additional bridging therapy prior to the recommended lymphodepleting chemotherapy was at the discretion of the investigator and dependent on the patient's disease burden. Lymphodepleting chemotherapy was started 14 to 5 days before CTL019 infusion (D1) to allow for at least 48 hours from last dose of lymphodepleting chemotherapy to CTL019 infusion. The lymphodepleting regimen was: Fludarabine (25 mg/m\^2 intravenously \[i.v.\] daily for 3 doses) and cyclophosphamide (250 mg/m\^2 i.v. daily for 3 doses starting with the first dose of fludarabine).
Novartis Investigative Site, Melbourne
Weill Cornell Medical College, New York
University of Pennsylvania Perelman School of Medicine, Philadelphia
Novartis Investigative Site, Milan
Emory University School of Medicine/Winship Cancer Institute SC CTL019, Atlanta
The Ohio State University James Cancer Hospital &, Columbus
Uni of Michigan Health System SC CTL019, Ann Arbor
Novartis Investigative Site, Cologne
University of Minnesota, Minneapolis
University of Chicago Medical Center Hematology and Oncology SC - CTL019B2207J, Chicago
University of Kansas Cancer Center SC - CTL019C2201, Westwood
Novartis Investigative Site, Pierre-Bénite
MD Anderson Cancer Center SC, Houston
UCSF Medical Center ., San Francisco
Novartis Investigative Site, Würzburg
Oregon Health Sciences University Oregon Health & Sci Uni, Portland
Sidney Kimmel Comprehensive Cancer Center SC-2, Baltimore
Novartis Investigative Site, Camperdown
Novartis Investigative Site, Vienna
Novartis Investigative Site, Hamilton
Novartis Investigative Site, Montreal
Novartis Investigative Site, Fukuoka
Novartis Investigative Site, Sapporo
Novartis Investigative Site, Chuo Ku
Novartis Investigative Site, Amsterdam
Novartis Investigative Site, Oslo
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY