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Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma
Sponsor: Kite, A Gilead Company
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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2023-02-10
Completion Date
2031-03
Last Updated
2026-03-03
Healthy Volunteers
No
Conditions
Interventions
Axicabtagene Ciloleucel
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells
Cyclophosphamide
Administered intravenously
Fludarabine
Administered intravenously
Etoposide
Administered intravenously
Rituximab
Administered intravenously
Doxorubicin
Administered intravenously
Vincristine
Administered intravenously
Prednisone
Administered orally
Locations (90)
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
University of Iowa
Iowa City, Iowa, United States
The University of Kansas Hospital
Westwood, Kansas, United States
Norton Cancer Institute, St. Matthews Campus
Shelbyville, Kentucky, 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
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
Montefiore Medical Center
The Bronx, New York, United States
Novant Health Cancer Institute- Hematology
Charlotte, North Carolina, United States
Oncology Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Prisma Health Cancer Institute
Greenville, South Carolina, 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
Intermountain LDS Hospital/Blood and Marrow Transplant/ Acute Leukemia Program
Salt Lake City, Utah, 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
Universitätsklinikum St. Pölten
Sankt Pölten, 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
Centre Leon Berard
Cedex Lyon 08, France
CHU Dijon
Dijon, France
Hopital Claude Huriez CHU Lille, Service Maladies du sang
Lille, France
Hopital Saint Eloi
Montpellier, France
Centre Hospitalier Universitaire de Nice
Nice, France
Hopital Henri MONDOR, APHP
Paris, France
CHU Pontchaillou
Rennes, France
Centre Hospitalier Universitaire(CHU) de Toulouse
Toulouse, France
Helios Klinikum Berlin-Buch
Berlin, Germany
Charite Universitaetsmedizin Berlin
Berlin, Germany
Universitätsklinikum bonn, medizinische klinik III
Bonn, Germany
Uniklinikum Duesseldorf, Klinik fuer Haematologie, Onkologie und klinische Immunologie
Düsseldorf, Germany
Universitätsklinik Erlangen
Erlangen, Germany
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy
ASST Degli Spedali Civili di Brescia
Brescia, Italy
Ospedale San Raffaele
Milan, Italy
Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia
Perugia, Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Reggio Calabria, Italy
Universita Cattolica del Sacro Cuore
Rome, Italy
IRCCS Istituto Clinico Humanitas
Rozzano, Italy
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, Japan
Tohoku University Hospital
Miyagi, Japan
Osaka University Hospital
Osaka, Japan
Juntendo University Hospital
Tokyo, Japan
Tokyo Metropolitan Komagome Hospital
Tokyo, Japan
Academisch Medisch Centrum
Amsterdam, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Maastricht Universitair Medisch Centrum
Maastricht, 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 Universitario Marqués de Valdecilla
Santander, Spain
Hospital Universitario Virgen del Rocio
Seville, 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