Last updated on August 2020

A Study Comparing BGB-3111 With Bendamustine Plus Rituximab in Patients With Previously Untreated CLL or SLL


Brief description of study

This study will enroll subjects with previously untreated CLL/SLL into three cohorts (Cohort 1 without del[17p] and Cohorts 2 and 3 with del[17p]). Cohort 1 subjects will receive either zanubrutinib alone or "bendamustine (B) and rituximab (R)". Cohort 2 subjects will receive zanubrutinib alone. Once Cohort 2 has finished enrollment, Cohort 3 will be opened in selected countries/sites where patients will receive zanubrutinib and venetoclax. The primary purpose is to evaluate the efficacy and safety of zanubrutinib versus bendamustine and rituximab in Cohort 1.

Detailed Study Description

This is a global phase 3, open label, randomized study of zanubrutinib versus bendamustine plus rituximab (B+R) in subjects with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), including subjects without del(17p) [Cohort 1] and subjects with del(17p) [Cohort 2 and Cohort 3]. Subjects 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. Subjects in Cohort 2 will receive treatment with zanubrutinib. Subjects 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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