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
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key 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.
Key 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.
Primary outcome measure(s)
Event-free Survival (EFS) by Blinded Central Assessment — Up to 5 years EFS, is defined as the time from randomization to the earliest occurrence of death due to any cause, disease progression/relapse, initiation of any non-protocol specified subsequent new lymphoma therapy for the treatment of residual disease or Biopsy-proven residual disease at the Month 6 disease assessment or later, regardless of whether subsequent new lymphoma therapy is initiated or not.
Trial sites (85)
Facility
City
Region
Status
University of Alabama Hospital
Birmingham
Alabama
Banner MD Anderson Cancer Center
Gilbert
Arizona
Mayo Clinic
Phoenix
Arizona
UC San Diego Moores Cancer Center
La Jolla
California
University of California Los Angeles (UCLA)
Los Angeles
California
Colorado Blood Cancer Institute
Denver
Colorado
Moffitt Cancer Center
Tampa
Florida
Georgia Cancer Center at Augusta University
Augusta
Georgia
Northwestern Memorial Hospital
Chicago
Illinois
University of Chicago Medical Center
Chicago
Illinois
University of Iowa
Iowa City
Iowa
The University of Kansas Hospital
Westwood
Kansas
Norton Cancer Institute, St. Matthews Campus
Shelbyville
Kentucky
Ochsner Clinic Foundation
New Orleans
Louisiana
University of MD Greenebaum Comprehensive Cancer Center
Baltimore
Maryland
Dana-Farber Cancer Institute
Boston
Massachusetts
University of Michigan
Ann Arbor
Michigan
Mayo Clinic Cancer Center Outpatient Pharmacy
Rochester
Minnesota
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack
New Jersey
Roswell Park Cancer Institute
Buffalo
New York
Weill Cornell Medical College - NewYork Presbyterian Hospital
New York
New York
Columbia University Medical Center
New York
New York
University of Rochester Medical Center
Rochester
New York
Montefiore Medical Center
The Bronx
New York
Novant Health Cancer Institute- Hematology
Charlotte
North Carolina
Prisma Health Cancer Institute
Greenville
South Carolina
Tennessee Oncology, PLLC
Nashville
Tennessee
Henry-Joyce Cancer Center
Nashville
Tennessee
University of Texas Southwestern Medical Center
Dallas
Texas
The University of Texas, MD Anderson Cancer Center
Houston
Texas
Intermountain LDS Hospital/Blood and Marrow Transplant/ Acute Leukemia Program
Salt Lake City
Utah
Virginia Commonwealth University
Richmond
Virginia
Royal Prince Alfred Hospital
Camperdown
New South Wales
Royal Brisbane and Women's Hospital
South Brisbane
Queensland
Peter MacCallum Cancer Center
Melbourne
Victoria
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
+ 45 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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