331
Participants
Start Date
May 7, 2019
Primary Completion Date
May 6, 2021
Study Completion Date
February 11, 2026
Tisagenlecleucel after optional bridging and lymphodepleting chemotherapy
Investigator's choice of optional platinum-based immunochemotherapy (ie. R-ICE, R-GemOx, R-GDP, R-DHAP) + Lymphodepleting chemotherapy (fludarabine with cyclophosphamide or bendamustine) + Tisagenlecleucel (a second generation CAR-T composed of a CD19 antigen-binding domain, a 4-1BB costimulatory domain and a CD3-ζ signaling domain)
Platinum-based immunochemotherapy followed in responding patients with high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT)
"Investigator's choice of platinum-based immunochemotherapy (ie. R-ICE, R-GemOx, R-GDP, R-DHAP)+ High dose chemotherapy (ie. BEAM) + autologous HSCT.~\*Ibrutinib or lenalidomide may be used in patients who are no longer eligible for autologous HSCT after 2 cycles of immunochemotherapy"
Novartis Investigative Site, Vienna
Novartis Investigative Site, Darlinghurst
Novartis Investigative Site, Melbourne
Novartis Investigative Site, Leuven
Novartis Investigative Site, Salzburg
Novartis Investigative Site, Murdoch
Novartis Investigative Site, Zurich
Novartis Investigative Site, Taipei
Novartis Investigative Site, Berlin
Uni Pennsylvania Abramson Cncr Ctr, Philadelphia
Novartis Investigative Site, Rozzano
Novartis Investigative Site, Milan
Novartis Investigative Site, Hamburg
Novartis Investigative Site, Madrid
Novartis Investigative Site, Madrid
MUSC Hollings Cancer Center, Charleston
Emory University School of Medicine Winship Cancer Institute, Atlanta
Novartis Investigative Site, Toulouse
Mayo Clinic Jacksonville, Jacksonville
Novartis Investigative Site, Montpellier
Novartis Investigative Site, Salamanca
Tennessee Oncology PLLC, Chattanooga
The Ohio State University, Columbus
Novartis Investigative Site, Nantes
Jewish Hospital, Cincinnati
Wayne State University-Karmanos Cancer Institute, Detroit
Novartis Investigative Site, Cologne
Novartis Investigative Site, Lille
Uni of Chi Medi Ctr Hema and Onco, Chicago
University of Kansas Cancer Center, Kansas City
Uni of Nebraska Med Ctr, Omaha
Novartis Investigative Site, Pierre-Bénite
Texas Oncology-Baylor Scott and White, Dallas
Novartis Investigative Site, Paris
Uni of Texas MD Anderson Ca Center, Houston
Methodist Hospital, San Antonio
St Davids South Austin Medical Ctr, Austin
Sarah Cannon Research Institute, Denver
Novartis Investigative Site, Munich
Novartis Investigative Site, Ulm
University of California Los Angeles, Los Angeles
Moores UC San Diego Cancer Center, La Jolla
Novartis Investigative Site, Regensburg
UCSF Medical Center, San Francisco
Oregon Health Sciences Univ, Portland
Novartis Investigative Site, Beijing
Novartis Investigative Site, Beijing
Novartis Investigative Site, Singapore
Novartis Investigative Site, Singapore
Novartis Investigative Site, Shanghai
Hackensack Uni Medical Center, Hackensack
Uni of Wisconsin Carbone Cancer Ctr, Madison
Novartis Investigative Site, Salvador
Novartis Investigative Site, São Paulo
Novartis Investigative Site, Leipzig
Novartis Investigative Site, Hong Kong
Novartis Investigative Site, Roma
Kyushu University Hospital, Fukuoka
Novartis Investigative Site, Fukuoka
Hokkaido University Hospital, Sapporo
Novartis Investigative Site, Sapporo
Novartis Investigative Site, Sendai
Tohoku University Hospital, Sendai
Novartis Investigative Site, Amsterdam
Amsterdam UMC, locatie AMC, Amsterdam
Novartis Investigative Site, Utrecht
UMC Utrecht Cancer Center, Utrecht
Novartis Investigative Site, Oslo
Novartis Investigative Site, L'Hospitalet de Llobregat
Novartis Investigative Site, Barcelona
Novartis Investigative Site, Birmingham
Novartis Investigative Site, London
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY