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A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312)
Sponsor: Acerta Pharma BV
Summary
Phase 3 randomized, double-blind, placebo-controlled, study assessing the efficacy and safety of acalabrutinib plus rituximab,cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) vs placebo plus R-CHOP in subjects ≤75 years of age with previously untreated non-germinal center diffuse large B-cell lymphoma.
Official title: Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤75 Years With Previously Untreated Non-GCB DLBCL
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
611
Start Date
2020-10-08
Completion Date
2027-02-22
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
acalabrutinib
Investigational Product
placebo
Placebo comparator
Prednisone
Investigational Product
Rituximab
Investigational Product
Cyclophosphamide
Investigational Product
Vincristine
Investigational Product
Doxorubicin
Investigational Product
Locations (243)
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Irvine, California, United States
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Aurora, Colorado, United States
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Norwich, Connecticut, United States
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Fort Myers, Florida, United States
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Orlando, Florida, United States
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St. Petersburg, Florida, United States
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Tallahassee, Florida, United States
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West Palm Beach, Florida, United States
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Fort Wayne, Indiana, United States
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Des Moines, Iowa, United States
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Wichita, Kansas, United States
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Louisville, Kentucky, United States
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Baltimore, Maryland, United States
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Grand Rapids, Michigan, United States
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Minneapolis, Minnesota, United States
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St Louis, Missouri, United States
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Albany, New York, United States
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New York, New York, United States
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New York, New York, United States
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Stony Brook, New York, United States
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Charlotte, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Eugene, Oregon, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Nashville, Tennessee, United States
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Fort Sam Houston, Texas, United States
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Lubbock, Texas, United States
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Salem, Virginia, United States
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Camperdown, Australia
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Darlinghurst, Australia
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Heidelberg, Australia
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Hobart, Australia
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Kogarah, Australia
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Nedlands, Australia
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Westmead, Australia
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Linz, Austria
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Wels, Austria
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Antwerp, Belgium
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Bruges, Belgium
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Goiânia, Brazil
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Passo Fundo, Brazil
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Porto Alegre, Brazil
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Porto Alegre, Brazil
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Ribeirão Preto, Brazil
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Rio de Janeiro, 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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Vancouver, British Columbia, Canada
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Toronto, CA, Canada
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London, Ontario, Canada
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Lévis, Quebec, Canada
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Montreal, Quebec, Canada
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Beijing, China
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Beijing, China
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Guangzhou, China
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Guangzhou, China
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Hangzhou, China
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Harbin, China
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Pune, India
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Afula, Israel
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Ashdod, Israel
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Beersheba, Israel
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Haifa, Israel
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Haifa, Israel
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Haifa, Israel
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Holon, Israel
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Jerusalem, Israel
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Chiba, Japan
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Niigata, Japan
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Osaka, Japan
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Taipei, Taiwan
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