Last updated on October 2020

A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL


Brief description of study

The primary objective of this study is to compare efficacy between zanubrutinib versus bendamustine and rituximab in patients with previously untreated CLL/SLL, as measured by progression free survival.

Detailed Study Description

This is a global phase 3, open label, randomized study of zanubrutinib versus bendamustine plus rituximab (B+R) in participants with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), including participants without del(17p) [Cohort 1] and participants with del(17p) [Cohort 2 and Cohort 3]. Participants in Cohort 1 are randomized 1:1 to zanubrutinib (Arm A) or bendamustine plus rituximab (Arm B). Randomization will be stratified by age, Binet stage, immunoglobulin variable region heavy chain (IGHV) mutational status, and geographic region. Participants in Cohort 2 will receive treatment with zanubrutinib. Participants in Cohort 3 will receive treatment with zanubrutinib and venetoclax.

Clinical Study Identifier: NCT03336333

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Emory University

Atlanta, GA United States
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Augusta University

Augusta, GA United States
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Northwestern University

Chicago, IL United States
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Montgomery Cancer Center

Mount Sterling, KY United States
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Research Medical Center - Kansas

Kansas City, MO United States
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Barnes Jewish Hospital

Saint Louis, MO United States
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Washington University

Saint Louis, MO United States
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Summit Medical Group, PA

Florham Park, NJ United States
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Mount Sinai

New York, NY United States
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University of Rochester

Rochester, NY United States
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Tennessee Oncology, PLLC

Nashville, TN United States
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Texas Oncology - Tyler

Tyler, TX United States
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University of Virginia

Charlottesville, VA United States
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Concord Hospital

Concord, Australia
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The Tweed Hospital

Tweed Heads, Australia
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Westmead Hospital

Westmead, Australia
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The Queen Elizabeth Hospital

Woodville South, Australia
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Monash Medical Centre

Bentleigh East, Australia
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Box Hill Hospital

Box Hill, Australia
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Marc Andre

Yvoir, Belgium
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North Shore Hospital

North Shore, New Zealand
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Palmerston North Hospital

Palmerston North, New Zealand
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Christchurch Hospital

Christchurch, New Zealand
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Tauranga Hospital

Tauranga, New Zealand
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Kaluga Regional Hospital

Kaluga, Russian Federation
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Central City Hospital # 7

Yekaterinburg, Russian Federation
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Derriford Hospital

Plymouth, United Kingdom
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Southampton General Hospital

Southampton, United Kingdom
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The Royal Wolverhampton NHS Trust

Wolverhampton, United Kingdom
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Recruitment Status: Open


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