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ACTIVE NOT RECRUITING
NCT03836261
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Acalabrutinib

Acalabrutinib,

DRUG

Venetoclax

Venetoclax

DRUG

Chemoimmunotherapy

fludarabine/cyclophosphamide/rituximab (FCR), bendamustine/rituximab (BR)

DRUG

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