OVERVIEW
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) (ZUMA-23)
PROTOCOL 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.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
High-risk Large B-cell Lymphoma (LBCL)
Gender
N/A
Date
February 2023 - March 2031
Study Type
Interventional
Study Phase
Phase 3
Product
Axicabtagene Ciloleucel, Cyclophosphamide, Fludarabine, Etoposide, Rituximab, Doxorubicin, Vincristine, Prednisone
Eligibility information
Inclusion criteria
- Histologically confirmed large B cell lymphoma (LBCL) based on 2016 World Health Organization (WHO) classification by local pathology lab assessment, including of the following:
- Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS)
- High-grade B-cell lymphoma (HGBL)
- Note: Transformed DLBCL from follicular lymphoma or from marginal zone lymphoma is eligible if no prior treatment with anthracycline-containing regimen.
- High-risk disease defined as an International Prognostic Index (IPI) score of 4 or 5 at initial diagnosis.
- Have received only 1 cycle of rituximab plus chemotherapy (R-chemotherapy).
- Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function.
- Females of childbearing potential must have a negative serum or urine pregnancy test.
Exclusion criteria
- The following WHO 2016 subcategories by local assessment:
- T-cell/histiocyte-rich LBCL
- Primary DLBCL of the central nervous system (CNS)
- Primary mediastinal (thymic) LBCL
- B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma
- Burkitt lymphoma
- History of Richter's transformation of chronic lymphocytic leukemia
- Presence of detectable cerebrospinal fluid (CSF)-malignant cells, brain metastases, or a history of CNS involvement of lymphoma.
- Presence of cardiac lymphoma involvement.
- Any prior treatment for LBCL other than the 1 cycle of R-chemotherapy.
- History of severe immediate hypersensitivity reaction to any of the agents used in this study.
- Presence of CNS disorder. History of stroke, transient ischemic attack, or posterior reversible encephalopathy syndrome (PRES) within 12 months prior to enrollment.
- History of acute or chronic active hepatitis B or C infection.
- Positive for human immunodeficiency virus (HIV) unless taking appropriate anti-HIV medications, with an undetectable viral load by PCR and with a cluster of differentiation 4 (CD4) count > 200 cells/uL.
- Medical conditions or residual toxicities from prior therapies likely to interfere with assessment of safety or efficacy of study treatment. Please refer to protocol for further details.
- History of clinically significant cardiac disease within 12 months before enrollment.
- History of any medical condition requiring maintenance systemic immunosuppression/systemic disease modifying agents within the last 2 years.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (85)
University of Alabama Hospital
Birmingham, Alabama, United States, 35233
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
University of California Los Angeles (UCLA)
Los Angeles, California, United States, 90095
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States, 30912
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60612
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
The University of Kansas Hospital
Westwood, Kansas, United States, 66205
Norton Cancer Institute, St. Matthews Campus
Shelbyville, Kentucky, United States, 40065
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
University of MD Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Mayo Clinic Cancer Center Outpatient Pharmacy
Rochester, Minnesota, United States, 55902
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Roswell Park Cancer Institute
Buffalo, New York, United States, 14203
Weill Cornell Medical College - NewYork Presbyterian Hospital
New York, New York, United States, 10021
Columbia University Medical Center
New York, New York, United States, 10032
University of Rochester Medical Center
Rochester, New York, United States, 14642
Novant Health Cancer Institute- Hematology
Charlotte, North Carolina, United States, 28204
Prisma Health Cancer Institute
Greenville, South Carolina, United States, 29615
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030
Intermountain LDS Hospital/Blood and Marrow Transplant/ Acute Leukemia Program
Salt Lake City, Utah, United States, 84143
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Royal Brisbane and Women's Hospital
South Brisbane, Queensland, Australia, 4101
Zuniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU
Salzburg, Austria, 5020
Medizinische Universität Wien (AKH Wien, Medical University Vienna and General Hospital Vienna)
Vienna, Austria, 01090
Hopital Claude Huriez CHU Lille, Service Maladies du sang
Lille, France, 59037
Centre Hospitalier Universitaire(CHU) de Toulouse
Toulouse, France, 31100
Universitätsklinikum bonn, medizinische klinik III
Bonn, Germany, 53127
Uniklinikum Duesseldorf, Klinik fuer Haematologie, Onkologie und klinische Immunologie
Düsseldorf, Germany, 40225
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138
Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia
Perugia, Italy, 06132
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Reggio Calabria, Italy, 89133
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, Japan, 602-8566,
Maastricht Universitair Medisch Centrum
Maastricht, Netherlands, 62002
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, 4200-072
Addenbrookes Hospital (Cambridge University Hospitals NHS Foundation Trust)
Birmingham, United Kingdom, B15 2TH
University Hospitals Southampton
Southampton, United Kingdom, SO16 6YD
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