Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma
NCT ID: NCT05605899
Last Updated: 2025-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
300 participants
INTERVENTIONAL
2023-02-10
2031-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Axicabtagene Ciloleucel
Participants will receive cyclophosphamide 500 mg/m\^2/day intravenously (IV) and fludarabine 30 mg/m\^2/day IV lymphodepletion chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0.
Axicabtagene Ciloleucel
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells
Cyclophosphamide
Administered intravenously
Fludarabine
Administered intravenously
Standard of Care Therapy
Participants will receive the investigator's choice of one of the following therapies/dosing schedules:
* Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for a total of 6 cycles (21-day cycle)
* Rituximab 375 mg/m\^2 on Day 1
* Cyclophosphamide 750 mg/m\^2 on Day 1
* Doxorubicin 50 mg/m\^2 on Day 1
* Vincristine 1.4 mg/m\^2 (maximum 2 mg) on Day 1
* Prednisone 40 mg/m\^2 on Day 1 through Day 5
* Dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) for a total of 6 cycles (21-day cycle)
* Rituximab 375 mg/m\^2 on Day 1
* Etoposide 50 mg/m\^2 on Days 1 to 4
* Doxorubicin 10 mg/m\^2 on Days 1 to 4
* Vincristine 0.4 mg/m\^2 on Days 1 to 4
* Cyclophosphamide 750 mg/m\^2 on Day 5
* Prednisone 60 mg/m\^2 twice daily on Days 1 to 5
Cyclophosphamide
Administered intravenously
Etoposide
Administered intravenously
Rituximab
Administered intravenously
Doxorubicin
Administered intravenously
Vincristine
Administered intravenously
Prednisone
Administered orally
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Kite, A Gilead Company
INDUSTRY
Responsible Party
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Principal Investigators
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Kite Study Director
Role: STUDY_DIRECTOR
Kite, A Gilead Company
Locations
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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
Countries
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Central Contacts
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Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2022-501489-24-00
Identifier Type: OTHER
Identifier Source: secondary_id
KT-US-484-0136
Identifier Type: -
Identifier Source: org_study_id
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