Last updated on July 2019

Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma


Brief description of study

The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

Detailed Study Description

This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.

Standard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.

Clinical Study Identifier: NCT03391466

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University of Chicago

Chicago, IL United States
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Mayo Clinic

Rochester, MN United States
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Swedish Cancer Institute

Seattle, WA United States
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University of Iowa

Iowa City, IA United States
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Stanford University

Stanford, CA United States
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Cleveland Clinic

Cleveland, OH United States
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University of Maryland

Baltimore, MD United States
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Memorial Sloan Kettering

New York, NY United States
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Vanderbilt University

Nashville, TN United States
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MD Anderson Cancer Center

Houston, TX United States
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University of Virginia Health System

Charlottesville, VA United States
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UCLA

Santa Monica, CA United States
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Stanford Cancer Institute

Stanford, CA United States
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Moffitt Cancer Center

Tampa, FL United States
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Northwestern University

Chicago, IL United States
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Mayo Clinic, Patient Location

Rochester, MN United States
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Thomas Jefferson University

Philadelphia, PA United States
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UPMC Hillman Cancer Center

Pittsburgh, PA United States
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Henry-Joyce Cancer Center

Nashville, TN United States
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Erasmus Medical Center

Rotterdam, Netherlands
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Barts Health NHS Trust

London, United Kingdom
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Mayo Clinic Hospital

Phoenix, AZ United States
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Recruitment Status: Open


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