Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL
NCT ID: NCT03836261
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
984 participants
INTERVENTIONAL
2019-02-25
2027-01-31
Brief Summary
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Detailed Description
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The study includes screening (35 days), treatment (from randomization until study drug discontinuation) and follow-up phase.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Acalabrutinib, Venetoclax
Acalabrutinib in combination with Venetoclax
Acalabrutinib
Acalabrutinib,
Venetoclax
Venetoclax
Acalabrutinib, Venetoclax, Obinutuzumab
Acalabrutinib in combination with Venetoclax with Obinutuzumab
Acalabrutinib
Acalabrutinib,
Venetoclax
Venetoclax
Obinutuzumab
Obinutuzumab
Chemoimmunotherapy
Chemoimmunotherapy
FCR: Fludarabine, Cyclophosphamide and Rituximab
BR: Bendamustine and Rituximab
Chemoimmunotherapy
fludarabine/cyclophosphamide/rituximab (FCR), bendamustine/rituximab (BR)
Interventions
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Acalabrutinib
Acalabrutinib,
Venetoclax
Venetoclax
Chemoimmunotherapy
fludarabine/cyclophosphamide/rituximab (FCR), bendamustine/rituximab (BR)
Obinutuzumab
Obinutuzumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Diagnosis of CLL that meets published diagnostic criteria (Hallek et al. 2018)
* Active disease per IWCLL 2018 criteria that requires treatment.
* Participants must use highly effective birth control throughout the study.
Exclusion Criteria
* Detected del(17p) or TP53 mutation.
* Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (e.g., Richter's transformation, prolymphocytic leukemia \[PLL\], or diffuse large B cell lymphoma \[DLBCL\]), or central nervous system (CNS) involvement by leukemia.
* History of confirmed progressive multifocal leukoencephalopathy (PML).
* Received any investigational drug within 30 days before first dose of study drug.
* Major surgical procedure within 30 days before the first dose of study drug.
* Significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 or 4 cardiac disease. Note: Subjects with controlled, asymptomatic atrial fibrillation are allowed to enroll on study.
* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach, or extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
* Received a live virus vaccination within 28 days of first dose of study drug.
* Known history of infection with human immunodeficiency virus (HIV).
* Serologic status reflecting active hepatitis B or C infection.
* History of known hypersensitivity or anaphylactic reactions to study drugs or excipients.
* History of stroke or intracranial hemorrhage within 6 months before first dose of study drug.
* Known bleeding disorders.
* Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists.
* Female participants must not be breastfeeding or pregnant.
* Concurrent participation in another therapeutic clinical trial.
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Acerta Pharma BV
INDUSTRY
Responsible Party
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Principal Investigators
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Jennifer Brown
Role: PRINCIPAL_INVESTIGATOR
Dana Farber Mass General Brigham Cancer Care Inc
Barbara Eichhorst
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Köln
Arnon Kater
Role: PRINCIPAL_INVESTIGATOR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Paolo Ghia
Role: PRINCIPAL_INVESTIGATOR
OSPEDALE S. RAFFAELE - MILANO
John Seymour
Role: PRINCIPAL_INVESTIGATOR
Peter MacCallum Cancer Ctr
Locations
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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 City, , 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
Countries
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References
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Brown JR, Seymour JF, Jurczak W, Aw A, Wach M, Illes A, Tedeschi A, Owen C, Skarbnik A, Lysak D, Eom KS, Simkovic M, Pavlovsky MA, Kater AP, Eichhorst B, Miller K, Munugalavadla V, Yu T, de Borja M, Ghia P; AMPLIFY investigators; AMPLIFY Investigators. Fixed-Duration Acalabrutinib Combinations in Untreated Chronic Lymphocytic Leukemia. N Engl J Med. 2025 Feb 20;392(8):748-762. doi: 10.1056/NEJMoa2409804. Epub 2025 Feb 5.
Alfaifi A, Bahashwan S, Alsaadi M, Ageel AH, Ahmed HH, Fatima K, Malhan H, Qadri I, Almehdar H. Advancements in B-Cell Non-Hodgkin's Lymphoma: From Signaling Pathways to Targeted Therapies. Adv Hematol. 2024 Nov 12;2024:5948170. doi: 10.1155/2024/5948170. eCollection 2024.
Davids MS, Lampson BL, Tyekucheva S, Wang Z, Lowney JC, Pazienza S, Montegaard J, Patterson V, Weinstock M, Crombie JL, Ng SY, Kim AI, Jacobson CA, LaCasce AS, Armand P, Arnason JE, Fisher DC, Brown JR. Acalabrutinib, venetoclax, and obinutuzumab as frontline treatment for chronic lymphocytic leukaemia: a single-arm, open-label, phase 2 study. Lancet Oncol. 2021 Oct;22(10):1391-1402. doi: 10.1016/S1470-2045(21)00455-1. Epub 2021 Sep 14.
Gordon MJ, Danilov AV. The evolving role of Bruton's tyrosine kinase inhibitors in chronic lymphocytic leukemia. Ther Adv Hematol. 2021 Jan 30;12:2040620721989588. doi: 10.1177/2040620721989588. eCollection 2021.
Other Identifiers
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ACE-CL-311
Identifier Type: -
Identifier Source: org_study_id
D8221C00001
Identifier Type: OTHER
Identifier Source: secondary_id
2023-509349-11-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-002443-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NCT05211856
Identifier Type: -
Identifier Source: nct_alias