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Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL
Sponsor: Acerta Pharma BV
Summary
The purpose of this study is to evaluate the efficacy and safety of acalabrutinib in combination with venetoclax and acalabrutinib in combination with venetoclax with and without obinutuzumab compared to chemoimmunotherapy in subjects with previously untreated CLL
Official title: A Randomized, Multicenter, Open-Label, Phase 3 Study to Compare the Efficacy and Safety of Acalabrutinib (ACP-196) in Combination With Venetoclax With and Without Obinutuzumab Compared to Investigator's Choice of Chemoimmunotherapy in Subjects With Previously Untreated Chronic Lymphocytic Leukemia Without Del(17p) or TP53 Mutation (AMPLIFY)
Key Details
Gender
All
Age Range
18 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
984
Start Date
2019-02-25
Completion Date
2027-01-31
Last Updated
2024-12-27
Healthy Volunteers
No
Conditions
Interventions
Acalabrutinib
Acalabrutinib,
Venetoclax
Venetoclax
Chemoimmunotherapy
fludarabine/cyclophosphamide/rituximab (FCR), bendamustine/rituximab (BR)
Obinutuzumab
Obinutuzumab
Locations (170)
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Los Angeles, California, United States
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Redondo Beach, California, United States
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Fort Wayne, Indiana, United States
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Wichita, Kansas, United States
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Louisville, Kentucky, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Canton, Ohio, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Fort Sam Houston, Texas, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Capital Federal, Argentina
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Córdoba, Argentina
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Adelaide, Australia
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Darlinghurst, Australia
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Heidelberg, Australia
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Kogarah, Australia
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Melbourne, Australia
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Nedlands, Australia
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Waratah, Australia
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Woolloongabba, Australia
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Krems, Austria
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Salzburg, Austria
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Vienna, Austria
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Goiânia, Brazil
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Porto Alegre, 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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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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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Vratsa, Bulgaria
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Beijing, China
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Beijing, China
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Beijing, China
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Changchun, China
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Changsha, China
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Chengdu, China
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Chongqing, China
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Guangzhou, China
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Guangzhou, China
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Hangzhou, China
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Nanchang, China
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Nanjing, China
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Shenyang, China
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Shenyang, China
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Tianjin, China
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Ürümqi, China
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Wenzhou, China
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Wuhan, China
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Wuhan, China
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Xi'an, China
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Zhengzhou, China
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Zhengzhou, China
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Brno, Czechia
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Hradec Králové, Czechia
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Olomouc, Czechia
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Ostrava - Poruba, Czechia
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Plzen - Lochotin, Czechia
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Prague, Czechia
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Aarhus, Denmark
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Copenhagen, Denmark
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Roskilde, Denmark
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Montpellier, France
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Paris, France
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Paris, France
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Paris, France
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Rennes, France
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Rouen, France
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Toulouse, France
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Villejuif, France
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Paderborn, Germany
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Würzburg, Germany
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Budapest, Hungary
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Budapest, Hungary
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Debrecen, Hungary
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Kaposvár, Hungary
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Haifa, Israel
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Jerusalem, Israel
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Jerusalem, Israel
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Petah Tikva, Israel
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Tel Aviv, Israel
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Tel Litwinsky, Israel
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Meldola, Italy
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Milan, Italy
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Milan, Italy
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Novara, Italy
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Ravenna, Italy
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Torino, Italy
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's-Hertogenbosch, Netherlands
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Almere Stad, Netherlands
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Amsterdam, Netherlands
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Arnhem, Netherlands
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Breda, Netherlands
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Brzozów, Poland
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Bydgoszcz, Poland
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Gdynia, Poland
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Krakow, Poland
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Lodz, Poland
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Lublin, Poland
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Wroclaw, Poland
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Wroclaw, Poland
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Moscow, Russia
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Moscow, Russia
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Saint Petersburg, Russia
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Saint Petersburg, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Sochi, Russia
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Tula, Russia
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Volgograd, Russia
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Dammam, Saudi Arabia
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Jeddah, Saudi Arabia
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Riyadh, Saudi Arabia
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Bratislava, Slovakia
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Bloemfontein, South Africa
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Cape Town, South Africa
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Pretoria, South Africa
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Randburg, South Africa
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Soweto, South Africa
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Incheon, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Badalona, Spain
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Barcelona, Spain
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Barcelona, Spain
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Madrid, Spain
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Madrid, Spain
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Majadahonda, Spain
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Salamanca, Spain
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Santander, Spain
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Valencia, Spain
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Gothenburg, Sweden
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Örebro, Sweden
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Uppsala, Sweden
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taoyuan, Taiwan
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Ankara, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Kurupelit, Turkey (Türkiye)
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Talas, Turkey (Türkiye)
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Cambridge, United Kingdom
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Canterbury, United Kingdom
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Wolverhampton, United Kingdom