Study Details

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)

Participation Requirements

Age

18 Years +

Sex

All

Healthy Volunteers

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 (65)

University of Alabama Hospital

Birmingham, Alabama, United States, 35233

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States, 85234

Mayo Clinic

Phoenix, Arizona, United States, 85054

UC San Diego Moores Cancer Center

La Jolla, California, United States, 92093

University of California Los Angeles (UCLA)

Los Angeles, California, United States, 90025

Stanford Cancer Institute

Palo Alto, California, United States, 94305

Colorado Blood Cancer Institute

Denver, Colorado, United States, 80218

Moffitt Cancer Center

Tampa, Florida, United States, 33612

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

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

University of Michigan

Ann Arbor, Michigan, United States, 48109

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

Montefiore Medical Center

Bronx, New York, United States, 10467

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

Avera Cancer Institute

Sioux Falls, South Dakota, United States, 57105

Tennessee Oncology, PLLC

Nashville, Tennessee, United States, 37203

Henry-Joyce Cancer Center

Nashville, Tennessee, United States, 37232

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75235

The University of Texas, MD Anderson Cancer Center

Houston, Texas, United States, 77030

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

Fred Hutchinson Cancer Center

Seattle, Washington, United States, 98109

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia, 2050

Royal Brisbane and Women's Hospital

South Brisbane, Queensland, Australia, 4101

Peter MacCallum Cancer Center

Melbourne, Victoria, Australia, 3000

Medizinische Universität Innsbruck

Innsbruck, Austria, 6020

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

Jewish General Hospital

Montreal, Canada, H3T1E2

The Ottowa Hospital- General Campus

Ottawa, Canada, K1H 8L6

Princess Margaret Cancer Centre

Toronto, Canada, M5G 2M9

CHU Bordeaux-Hopital Haut-Leveque

Bordeaux, France

Hopital Claude Huriez CHU Lille, Service Maladies du sang

Lille cedex, France, 59037

Hopital Saint Eloi

Montpellier CEDEX 05, France, 34295

Hopital Henri MONDOR, APHP

Paris, France, 94000

CHU Pontchaillou

Rennes CEDEX, France, 35033

Helios Klinikum Berlin-Buch

Berlin, Germany, 13125

Charite Universitaetsmedizin Berlin

Berlin, Germany

Universitätsklinikum bonn, medizinische klinik III

Bonn, Germany, 53127

Universitätsklinik Erlangen

Erlangen, Germany

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy, 40138

Ospedale San Raffaele

Milano, Italy, 20132

Universita Cattolica del Sacro Cuore

Rome, Italy

IRCCS Istituto Clinico Humanitas

Rozzano, Italy

Academisch Medisch Centrum

Amsterdam, Netherlands, 1081HV

University Medical Center Groningen

Groningen, Netherlands, 9700 RB

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands, 3508 GA

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.