75
Participants
Start Date
August 14, 2014
Primary Completion Date
May 29, 2018
Study Completion Date
May 24, 2019
CTL019 T-cells
A target dose of CTL019 transduced cells will consist of a single infusion of 2.0 to 5.0 x 10\^6 CTL019 transduced cells per kg body weight (for patients ≤ 50 kg) and 1.0 to 2.5 x 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg). The following cell dose ranges may be infused if all other safety release criteria are met: 0.2 to 5.0 x 10\^6 CTL019 transduced viable T cells per kg body weight (for patient ≤ 50 kg) and 0.1 to 2.5 x 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg).
Children's Hospital of Philadelphia, Philadelphia
Duke University Medical Center, Durham
Children's Healthcare of Atlanta SC-2, Atlanta
Cincinnati Children's Hospital, Cincinnati
University of Wisconsin Hospital and Clinics, Madison
University of Minnesota Medical Center, Minneapolis
Mercy Children's Kansas University, Kansas City
University of Utah, Salt Lake City
Childrens Hospital Los Angeles SC, Los Angeles
Stanford University Medical Center, Palo Alto
Oregon Health and Science University SC, Portland
University of Michigan, Ann Arbor
University of Texas Southwestern Medical Center SC, Dallas
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY