Spots Global Cancer Trial Database for Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL
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Trial Identification
Brief Title: Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for 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)
Study ID: NCT03836261
Conditions
Study Description
Brief 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
Detailed Description: This randomized, global, multicenter, open-label, Phase 3 study will evaluate the efficacy and safety of AV and AVG versus chemoimmunotherapy (FCR or BR) in subjects with previously untreated CLL without del(17p) or TP53. Subjects will be randomized in a 1:1:1 ratio into 3 arms through a block stratified randomization procedure. The study includes screening (35 days), treatment (from randomization until study drug discontinuation) and follow-up phase.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Los Angeles, California, United States
Research Site, Redondo Beach, California, United States
Research Site, Fort Wayne, Indiana, United States
Research Site, Wichita, Kansas, United States
Research Site, Louisville, Kentucky, United States
Research Site, New Orleans, Louisiana, United States
Research Site, Baltimore, Maryland, United States
Research Site, Boston, Massachusetts, United States
Research Site, New York, New York, United States
Research Site, Charlotte, North Carolina, United States
Research Site, Canton, Ohio, United States
Research Site, Pittsburgh, Pennsylvania, United States
Research Site, Pittsburgh, Pennsylvania, United States
Research Site, Fort Sam Houston, Texas, United States
Research Site, Spokane, Washington, United States
Research Site, Tacoma, Washington, United States
Research Site, Buenos Aires, , Argentina
Research Site, Buenos Aires, , Argentina
Research Site, Capital Federal, , Argentina
Research Site, Córdoba, , Argentina
Research Site, Adelaide, , Australia
Research Site, Darlinghurst, , Australia
Research Site, Heidelberg, , Australia
Research Site, Kogarah, , Australia
Research Site, Melbourne, , Australia
Research Site, Nedlands, , Australia
Research Site, Waratah, , Australia
Research Site, Woolloongabba, , Australia
Research Site, Krems, , Austria
Research Site, Salzburg, , Austria
Research Site, Vienna, , Austria
Research Site, Goiania, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Rio de Janeiro, , Brazil
Research Site, Rio de Janeiro, , Brazil
Research Site, Sao Paulo, , Brazil
Research Site, Sao Paulo, , Brazil
Research Site, São Paulo, , Brazil
Research Site, Plovdiv, , Bulgaria
Research Site, Sofia, , Bulgaria
Research Site, Vratsa, , Bulgaria
Research Site, Calgary, Alberta, Canada
Research Site, Edmonton, Alberta, Canada
Research Site, Vancouver, British Columbia, Canada
Research Site, Ottawa, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Quebec, , Canada
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Changchun, , China
Research Site, Changsha, , China
Research Site, Chengdu, , China
Research Site, Chongqing, , China
Research Site, Guangzhou, , China
Research Site, Guangzhou, , China
Research Site, Hangzhou, , China
Research Site, Nanchang, , China
Research Site, Nanjing, , China
Research Site, Shengyang, , China
Research Site, Shenyang, , China
Research Site, Shenyang, , China
Research Site, Tianjin, , China
Research Site, Urumchi, , China
Research Site, Wenzhou, , China
Research Site, Wuhan, , China
Research Site, Wuhan, , China
Research Site, Xian, , China
Research Site, Zhengzhou, , China
Research Site, Zhengzhou, , China
Research Site, Brno, , Czechia
Research Site, Hradec Kralove, , Czechia
Research Site, Olomouc, , Czechia
Research Site, Ostrava, , Czechia
Research Site, Plzen, , Czechia
Research Site, Praha, , Czechia
Research Site, Aarhus, , Denmark
Research Site, Copenhagen, , Denmark
Research Site, Roskilde, , Denmark
Research Site, Montpellier Cedex 5, , France
Research Site, Paris Cedex 10, , France
Research Site, Paris, , France
Research Site, Paris, , France
Research Site, Rennes Cedex 9, , France
Research Site, Rouen Cedex 1, , France
Research Site, Toulouse Cedex 9, , France
Research Site, Villejuif, , France
Research Site, Paderborn, , Germany
Research Site, Würzburg, , Germany
Research Site, Budapest, , Hungary
Research Site, Budapest, , Hungary
Research Site, Debrecen, , Hungary
Research Site, Kaposvár, , Hungary
Research Site, Haifa, , Israel
Research Site, Jerusalem, , Israel
Research Site, Jerusalem, , Israel
Research Site, Petah Tiqva, , Israel
Research Site, Tel Aviv, , Israel
Research Site, Tel Hashomer, , Israel
Research Site, Meldola, , Italy
Research Site, Milano, , Italy
Research Site, Milano, , Italy
Research Site, Novara, , Italy
Research Site, Ravenna, , Italy
Research Site, Torino, , Italy
Research Site, Incheon, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Almere, , Netherlands
Research Site, Amsterdam, , Netherlands
Research Site, Arnhem, , Netherlands
Research Site, Breda, , Netherlands
Research Site, Den Bosch, , Netherlands
Research Site, Brzozów, , Poland
Research Site, Bydgoszcz, , Poland
Research Site, Gdynia, , Poland
Research Site, Krakow, , Poland
Research Site, Lublin, , Poland
Research Site, Wrocław, , Poland
Research Site, Wrocław, , Poland
Research Site, Łódź, , Poland
Research Site, Moscow, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Saint Petersburg, , Russian Federation
Research Site, Saint-Petersburg, , Russian Federation
Research Site, Samara, , Russian Federation
Research Site, Sochi, , Russian Federation
Research Site, St Petersburg, , Russian Federation
Research Site, Tula, , Russian Federation
Research Site, Volgograd, , Russian Federation
Research Site, Dammam, , Saudi Arabia
Research Site, Jeddah, , Saudi Arabia
Research Site, Riyadh, , Saudi Arabia
Research Site, Bratislava, , Slovakia
Research Site, Bloemfontein, , South Africa
Research Site, Cape Town, , South Africa
Research Site, Johannesburg, , South Africa
Research Site, Pretoria, , South Africa
Research Site, Randburg, , South Africa
Research Site, Badalona(Barcelona), , Spain
Research Site, Barcelona, , Spain
Research Site, Barcelona, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Majadahonda, , Spain
Research Site, Salamanca, , Spain
Research Site, Santander, , Spain
Research Site, Valencia, , Spain
Research Site, Göteborg, , Sweden
Research Site, Uppsala, , Sweden
Research Site, Örebro, , Sweden
Research Site, Kaohsiung, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Tainan City, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taoyuan City, , Taiwan
Research Site, Ankara, , Turkey
Research Site, Ankara, , Turkey
Research Site, Izmir, , Turkey
Research Site, Kurupelit, , Turkey
Research Site, Talas, , Turkey
Research Site, Cambridge, , United Kingdom
Research Site, Canterbury, , United Kingdom
Research Site, Wolverhampton, , United Kingdom
Contact Details
Name: Jennifer Brown
Affiliation: Dana Farber Mass General Brigham Cancer Care Inc
Role: PRINCIPAL_INVESTIGATOR
Name: Barbara Eichhorst
Affiliation: Universitätsklinikum Köln
Role: PRINCIPAL_INVESTIGATOR
Name: Arnon Kater
Affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Role: PRINCIPAL_INVESTIGATOR
Name: Paolo Ghia
Affiliation: OSPEDALE S. RAFFAELE - MILANO
Role: PRINCIPAL_INVESTIGATOR
Name: John Seymour
Affiliation: Peter MacCallum Cancer Ctr
Role: PRINCIPAL_INVESTIGATOR
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