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Brief Title: Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma
Official Title: An Adaptive Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Axicabtagene Ciloleucel Versus Standard of Care Therapy as First-Line Therapy in Subjects With High-Risk Large B-Cell Lymphoma (ZUMA-23)
Study ID: NCT05605899
Brief Summary: The goal of this clinical study is to compare the study drug, axicabtagene ciloleucel, versus standard of care (SOC) in first-line therapy in participants with high-risk large B-cell lymphoma.
Detailed Description: Five years after randomization, participants who have received axicabtagene ciloleucel will transition to a separate long-term follow-up study (study KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama Hospital, Birmingham, Alabama, United States
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Mayo Clinic, Phoenix, Arizona, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
University of California Los Angeles (UCLA), Los Angeles, California, United States
Stanford Cancer Institute, Palo Alto, California, United States
Colorado Blood Cancer Institute, Denver, Colorado, United States
Moffitt Cancer Center, Tampa, Florida, United States
Georgia Cancer Center at Augusta University, Augusta, Georgia, United States
Northwestern Memorial Hospital, Chicago, Illinois, United States
University of Chicago Medical Center, Chicago, Illinois, United States
The University of Kansas Hospital, Westwood, Kansas, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
University of MD Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center Outpatient Pharmacy, Rochester, Minnesota, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Montefiore Medical Center, Bronx, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Weill Cornell Medical College - NewYork Presbyterian Hospital, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
Henry-Joyce Cancer Center, Nashville, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
The University of Texas, MD Anderson Cancer Center, Houston, Texas, United States
Virginia Commonwealth University, Richmond, Virginia, United States
Fred Hutchinson Cancer Center, Seattle, Washington, United States
Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
Royal Brisbane and Women's Hospital, South Brisbane, Queensland, Australia
Peter MacCallum Cancer Center, Melbourne, Victoria, Australia
Medizinische Universität Innsbruck, Innsbruck, , Austria
Zuniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU, Salzburg, , Austria
Medizinische Universität Wien (AKH Wien, Medical University Vienna and General Hospital Vienna), Vienna, , Austria
Jewish General Hospital, Montreal, , Canada
The Ottowa Hospital- General Campus, Ottawa, , Canada
Princess Margaret Cancer Centre, Toronto, , Canada
CHU Bordeaux-Hopital Haut-Leveque, Bordeaux, , France
Hopital Claude Huriez CHU Lille, Service Maladies du sang, Lille cedex, , France
Hopital Saint Eloi, Montpellier CEDEX 05, , France
Hopital Henri MONDOR, APHP, Paris, , France
CHU Pontchaillou, Rennes CEDEX, , France
Helios Klinikum Berlin-Buch, Berlin, , Germany
Charite Universitaetsmedizin Berlin, Berlin, , Germany
Universitätsklinik Erlangen, Erlangen, , Germany
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, , Italy
Ospedale San Raffaele, Milano, , Italy
Universita Cattolica del Sacro Cuore, Rome, , Italy
IRCCS Istituto Clinico Humanitas, Rozzano, , Italy
Academisch Medisch Centrum, Amsterdam, , Netherlands
University Medical Center Groningen, Groningen, , Netherlands
Universitair Medisch Centrum Utrecht, Utrecht, , Netherlands
Centro Hospitalar Universitario Lisboa Norte, E.P.E. - Hospital de Santa Maria, Lisbon, , Portugal
Instituto Portugues de Oncologia de Lisboa Francisco Gentil - E.P.E., Lisbon, , Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E., Porto, , Portugal
Institut Catala d'Oncologia, Barcelona, , Spain
Hospital Universitari Vall D'Hebron, Barcelona, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Clínico Universitario de Valencia, Valencia, , Spain
Addenbrookes Hospital (Cambridge University Hospitals NHS Foundation Trust), Birmingham, , United Kingdom
University Hospitals Southampton, Southampton, , United Kingdom
Name: Kite Study Director
Affiliation: Kite, A Gilead Company
Role: STUDY_DIRECTOR