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Brief Title: Tisagenlecleucel in Adult Patients With Aggressive B-cell Non-Hodgkin Lymphoma
Official Title: Tisagenlecleucel Versus Standard of Care in Adult Patients With Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma: A Randomized, Open Label, Phase III Trial (BELINDA)
Study ID: NCT03570892
Brief Summary: This is a randomized, open label, multicenter phase III trial comparing the efficacy, safety, and tolerability of tisagenlecleucel to Standard Of Care in adult patients with aggressive B-cell Non-Hodgkin Lymphoma after failure of rituximab and anthracycline containing frontline immunochemotherapy.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Moores UC San Diego Cancer Center, La Jolla, California, United States
University of California Los Angeles University of California LA, Los Angeles, California, United States
UCSF Medical Center, San Francisco, California, United States
Sarah Cannon Research Institute, Denver, Colorado, United States
Mayo Clinic Jacksonville Main Centre, Jacksonville, Florida, United States
Emory University School of Medicine/Winship Cancer Institute SC, Atlanta, Georgia, United States
Uni of Chi Medi Ctr Hema and Onco, Chicago, Illinois, United States
University of Kansas Cancer Center SC, Kansas City, Kansas, United States
Wayne State University - Karmanos Cancer Institute SC, Detroit, Michigan, United States
Uni of Nebraska Med Ctr, Omaha, Nebraska, United States
Hackensack Univ Medical Center, Hackensack, New Jersey, United States
Jewish Hospital, Cincinnati, Ohio, United States
The Ohio State University SC, Columbus, Ohio, United States
Oregon Health Sciences Univ SC, Portland, Oregon, United States
University of Pennsylvania, Abramson Cancer Center, Philadelphia, Pennsylvania, United States
MUSC Hollings Cancer Center, Charleston, South Carolina, United States
Sarah Cannon Research Institute ., Nashville, Tennessee, United States
St Davids South Austin Medical Ctr, Austin, Texas, United States
Baylor Scott and White Res Inst, Dallas, Texas, United States
University of Texas MD Anderson Cancer Center MD Anderson Cancer Center, Houston, Texas, United States
Methodist Hospital, San Antonio, Texas, United States
Uni of Wisconsin Carbone Cancer Ctr, Madison, Wisconsin, United States
Novartis Investigative Site, Darlinghurst, New South Wales, Australia
Novartis Investigative Site, Melbourne, Victoria, Australia
Novartis Investigative Site, Murdoch, Western Australia, Australia
Novartis Investigative Site, Salzburg, , Austria
Novartis Investigative Site, Vienna, , Austria
Novartis Investigative Site, Leuven, , Belgium
Novartis Investigative Site, Salvador, BA, Brazil
Novartis Investigative Site, Sao Paulo, , Brazil
Novartis Investigative Site, Beijing, , China
Novartis Investigative Site, Beijing, , China
Novartis Investigative Site, Shanghai, , China
Novartis Investigative Site, Lille, , France
Novartis Investigative Site, Montpellier cedex 5, , France
Novartis Investigative Site, Nantes Cedex 1, , France
Novartis Investigative Site, Paris 10, , France
Novartis Investigative Site, Pierre Benite, , France
Novartis Investigative Site, Toulouse, , France
Novartis Investigative Site, Regensburg, Bavaria, Germany
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Hamburg, , Germany
Novartis Investigative Site, Koeln, , Germany
Novartis Investigative Site, Leipzig, , Germany
Novartis Investigative Site, Muenchen, , Germany
Novartis Investigative Site, Ulm, , Germany
Novartis Investigative Site, Hong Kong, , Hong Kong
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Rozzano, MI, Italy
Novartis Investigative Site, Roma, RM, Italy
Kyushu University Hospital, Fukuoka city, Fukuoka, Japan
Hokkaido University Hospital, Sapporo city, Hokkaido, Japan
Tohoku University Hospital, Sendai city, Miyagi, Japan
Amsterdam UMC, locatie AMC, Amsterdam, , Netherlands
UMC Utrecht Cancer Center, Utrecht, , Netherlands
Novartis Investigative Site, Oslo, , Norway
Novartis Investigative Site, Singapore, , Singapore
Novartis Investigative Site, Singapore, , Singapore
Novartis Investigative Site, Salamanca, Castilla Y Leon, Spain
Novartis Investigative Site, Barcelona, Catalunya, Spain
Novartis Investigative Site, Hospitalet de LLobregat, Catalunya, Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Zurich, , Switzerland
Novartis Investigative Site, Taipei, , Taiwan
Novartis Investigative Site, Birmingham, , United Kingdom
Novartis Investigative Site, London, , United Kingdom
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR