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



Status:Recruiting
Conditions:Blood Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/13/2019
Start Date:November 2, 2017
End Date:October 2022
Contact:Aileen Cohen, MD
Email:clinicaltrials@beigene.com
Phone:781-801-1800

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An International, Phase 3, Open-Label, Randomized Study of BGB-3111 Compared With Bendamustine Plus Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

This study will enroll subjects with previously untreated CLL/SLL into two cohorts (Cohort 1
without del[17p] and Cohort 2 with del[17p]). Cohort 1 subjects will receive either "BGB-3111
alone" or "bendamustine (B) and rituximab (R)". Cohort 2 subjects will receive BGB-3111
alone. The primary purpose is to evaluate the efficacy and safety of BGB-3111 versus
bendamustine and rituximab in Cohort 1.

This is a global phase 3, open label, randomized study of BGB-3111 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]. Subjects in Cohort 1 are randomized 1:1 to BGB-3111 (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 receive treatment with BGB-3111.

Inclusion Criteria: All subjects

1. Unsuitable for chemoimmunotherapy with FCR in the opinion of the investigator.

2. Confirmed diagnosis of CD20-positive CLL or SLL.

3. Binet Stage C disease, or Binet Stage B or A disease requiring treatment.

4. ECOG performance status of 0, 1 or 2.

5. Life expectancy ≥ 6 months.

6. Adequate bone marrow function.

7. Adequate renal and hepatic function.

8. Females of childbearing potential and non-sterile males must agree to use highly
effective methods of birth control throughout the course of study

9. Male patients are eligible if vasectomized or if they agree to use of barrier
contraception with other methods described above throughout the course of study.

10. Written informed consent.

Exclusion Criteria: All subjects

1. Previous systemic treatment for CLL/SLL.

2. Known prolymphocytic leukemia or history of or suspected Richter's transformation.

3. Clinically significant cardiovascular disease.

4. Prior malignancy within the past 3 years, except for curatively treated basal or
squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the
cervix of breast.

5. Major surgery or significant injury ≤ 4 weeks prior to start of study treatment.

6. History of severe bleeding disorder.

7. History of stroke or intracranial hemorrhage within 6 months before the first dose of
study drug.

8. Severe or debilitating pulmonary disease.

9. Inability to swallow capsules or disease affecting gastrointestinal function.

10. Known central nervous system involvement by leukemia or lymphoma.

11. Active infection requiring systemic treatment.

12. Known infection with human immunodeficiency virus (HIV) or active hepatitis B or C
infection.

13. Vaccination with live vaccine within 35 days prior to the first dose of study drug.

14. Known hypersensitivity to BGB-3111, bendamustine, or rituximab or any other
ingredients of the study drugs.

15. Requires ongoing treatment with strong CYP3A inhibitor or inducer.

16. Pregnant or nursing females.

17. Concurrent participation in another therapeutic clinical trial.
We found this trial at
48
sites
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Danielle Brander, MD
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Christopher Flowers, MD
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Alexey Danilov, MD
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Paul Barr, MD
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Principal Investigator: Mazyar Shadman, MD
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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Augusta, Georgia 30912
Principal Investigator: Locke Bryan, MD
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Jennifer Brown, MD
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Craig Portell, MD
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Shuo Ma, MD
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Concord, New South Wales 2138
Principal Investigator: Emma Verner, MD
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Florham Park, New Jersey 07932
Principal Investigator: Benjamen Freeman, MD
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Henderson, Nevada 89052
Principal Investigator: Edwin Kingsley, MD
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2460 West Horizon Ridge Parkway
Henderson, Nevada 89052
Principal Investigator: Edwin Kingsley, MD
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Henderson, Nevada 89074
Principal Investigator: Edwin Kingsley, MD
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Henderson, Nevada 89128
Principal Investigator: Edwin Kingsley, MD
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Henderson, Nevada 89148
Principal Investigator: Edwin Kingsley, MD
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Kansas City, Missouri 64132
Principal Investigator: Suman Kambhampati, MD
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Kansas City, Missouri 64132
Principal Investigator: Suman Kambhampati, MD
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Principal Investigator: Edwin Kingsley, MD
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Lubbock, Texas 79410
Principal Investigator: Donald Quick, MD
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Mount Sterling, Kentucky 40353
Principal Investigator: Muhammad Zaydan, MD
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Nashville, Tennessee 37203
Principal Investigator: Ian Flinn, MD
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Nashville, Tennessee 37203
Principal Investigator: Ian Flinn, MD
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Nashville, Tennessee 37203
Principal Investigator: Ian Flinn, MD
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Nashville, Tennessee 37203
Principal Investigator: Ian Flinn, MD
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Nashville, Tennessee 37203
Principal Investigator: Ian Flinn, MD
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Nashville, Tennessee 37203
Principal Investigator: Ian Flinn, MD
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Nashville, Tennessee 37203
Principal Investigator: Ian Flinn, MD
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Nashville, Tennessee 58014
Principal Investigator: Ian Flinn, MD
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Nashville, Tennessee 37203
Principal Investigator: Ian Flinn, MD
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397 Wallace Road
Nashville, Tennessee 37203
Principal Investigator: Ian Flinn, MD
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Nashville, Tennessee 37203
Principal Investigator: Ian Flinn, MD
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Nashville, Tennessee 37203
Principal Investigator: Ian Flinn, MD
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Nashville, Tennessee 37203
Principal Investigator: Ian Flinn, MD
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: Ian Flinn, MD
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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New York, New York
Principal Investigator: Jonah Shulman, MD
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Nicole Lamanna, MD
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Andrew Zelenetz, MD
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Saint Louis, Missouri 63110
Principal Investigator: Brad Kahl, MD
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Saint Louis, Missouri 63110
Principal Investigator: Brad Kahl, MD
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Saint Louis, Missouri 63110
Principal Investigator: Brad Kahl, MD
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Saint Louis, Missouri 63129
Principal Investigator: Brad Kahl, MD
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Saint Louis, Missouri 63110
Principal Investigator: Brad Kahl, MD
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Saint Louis, Missouri 63110
Principal Investigator: Brad Kahl, MD
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Seattle, Washington 98108
Principal Investigator: Solomon Graf, MD
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Tyler, Texas 75702
Principal Investigator: Habte Yimer, MD
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Principal Investigator: Bruce Cheson, MD
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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Watertown, South Dakota 57201
Principal Investigator: Bipinkumar Amin, MD
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