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Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma
Sponsor: Kite, A Gilead Company
Summary
The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma
Official title: A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Follicular Lymphoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
231
Start Date
2022-09-22
Completion Date
2030-10
Last Updated
2025-10-15
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
Lenalidomide
Administered orally
Rituximab
Administered intravenously
Doxorubicin
Administered intravenously
Vincristine
Administered intravenously
Prednisone
Administered orally
Bendamustine
Administered intravenously
Locations (52)
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States
Stanford Health Care
Stanford, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
The University of Kansas Hospital
Westwood, Kansas, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Novant Health Cancer Institute Hematology - Charlotte
Charlotte, North Carolina, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
TriStar Centennial Medical Center - Cell Processing
Nashville, Tennessee, United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Hopital Henri Mondor
Créteil, France
CHU de Dijon
Dijon, France
Hôpital Claude Huriez-CHU de Lille
Lille, France
Institut Paoli-Calmettes
Marseille, France
Hopital Saint Eloi
Montpellier, France
Hopital Pitie-Salpetriere
Paris, France
CHU Bordeaux - Hospital Haut-Leveque - Centre Francois Magendie
Pessac, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
CHU de Poitiers
Poitiers, France
Hopital Pontchaillou - CHU Rennes
Rennes, France
Centre Henri Becquerel
Rouen, France
Universitatsmedizin Gottingen
Göttingen, Germany
Universitatsklinikum Koln Klinik I fur Innere Medizin
Würzburg, Germany
ASST Papa Giovanni XXIII
Bergamo, Italy
Azienda Ospedallero-Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
Bologna, Italy
Fondazione IRCCS - Istituto Nazionale Tumori
Milan, Italy
Ospedale San Raffaele
Milan, Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, Italy
Istituto Clinico Humanitas-IRCCS
Rozzano, Italy
Hyogo Medical University Hospital
Hyōgo, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Japan
Tohoku University Hospital
Miyagi, Japan
Okayama University Hospital
Okayama, Japan
Osaka University Hospital
Osaka, Japan
Hospital Universitari Vall d'Hebrón
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Instituto Catalan de Oncologia - Hospital Duran i Reynolds (ICO L'Hospitalet)
Barcelona, Spain
Hospital General Universitario Gregorio Maranon
Madrid, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
University Hospital Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
University College London Hospitals NHS Foundation Trust
London, United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
The University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, United Kingdom