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A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL
Sponsor: Acerta Pharma BV
Summary
This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle cell lymphoma.
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Bendamustine and Rituximab (BR) Alone Versus in Combination With Acalabrutinib (ACP-196) in Subjects With Previously Untreated Mantle Cell Lymphoma
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
635
Start Date
2017-04-05
Completion Date
2027-02-15
Last Updated
2026-10-08
Healthy Volunteers
No
Conditions
Interventions
Acalabrutinib
Administered orally (PO)
Bendamustine
Administered intravenously (IV)
Rituximab
Administered intravenously (IV)
Placebo
Placebo comparator
Locations (228)
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Tucson, Arizona, United States
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Downey, California, United States
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Santa Monica, California, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Tallahassee, Florida, United States
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West Palm Beach, Florida, United States
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Marietta, Georgia, United States
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Westwood, Kansas, United States
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Louisville, Kentucky, United States
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Ann Arbor, Michigan, United States
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Rochester, Minnesota, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Hackensack, New Jersey, United States
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Morristown, New Jersey, United States
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Hawthorne, New York, United States
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Lake Success, New York, United States
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Portland, Oregon, United States
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Charleston, South Carolina, United States
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Greenville, South Carolina, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Tyler, Texas, United States
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Charlottesville, Virginia, United States
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Fort Belvoir, Virginia, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Morgantown, West Virginia, United States
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Caba, Argentina
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Córdoba, Argentina
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Bedford Park, Australia
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Concord, Australia
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Frankston, Australia
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Gosford, Australia
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Heidelberg, Australia
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Herston, Australia
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Kogarah, Australia
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Murdoch, Australia
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Nedlands, Australia
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Newcastle, Australia
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Southport, Australia
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Sydney, Australia
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Woolloongabba, Australia
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Antwerp, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Roeselare, Belgium
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Sint-Niklaas, Belgium
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Bela Vista, Brazil
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Curitiba, Brazil
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Porto Alegre, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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Salvador, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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So Paulo, Brazil
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Vancouver, British Columbia, Canada
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Oshawa, Ontario, Canada
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Toronto, Ontario, Canada
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Edmonton, Canada
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Greenfield Park, Canada
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Halifax, Canada
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Beijing, China
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Changchun, China
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Changsha, China
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Changsha, China
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Chongqing, China
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Dalian, China
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Gongshu District, China
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Haidian District, China
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Harbin, China
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Nanchang, China
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Nanchang, China
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Nanjing, China
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Qingdao, China
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Shanghai, China
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Shenyang, China
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Suzhou, China
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Tianjian, China
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Tianjin, China
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Wenzhou, China
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Wuhan, China
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Wuhan, China
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Wuhou District, China
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Xicheng District, China
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Xuhui District, China
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Xuzhou, China
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Zhengzhou, China
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Zhengzhou, China