Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL
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
Eligibility
Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Inclusion Criteria:
* Men and women ≥18 years of age.
* 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:
* Any prior CLL-specific therapies.
* 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.
Primary outcome measure(s)
To evaluate the efficacy of acalabrutinib with venetoclax (Arm A) compared to chemoimmunotherapy fludarabine/cyclophosphamide/rituximab [FCR] or bendamustine/rituximab [BR] (Arm C): PFS — 6 years Progression-free survival (PFS) after randomization, defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the Independent Review Committee (IRC) according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 criteria
Trial sites (170)
Facility
City
Region
Status
Research Site
Los Angeles
California
Research Site
Redondo Beach
California
Research Site
Fort Wayne
Indiana
Research Site
Wichita
Kansas
Research Site
Louisville
Kentucky
Research Site
New Orleans
Louisiana
Research Site
Baltimore
Maryland
Research Site
Boston
Massachusetts
Research Site
New York
New York
Research Site
Charlotte
North Carolina
Research Site
Canton
Ohio
Research Site
Pittsburgh
Pennsylvania
Research Site
Pittsburgh
Pennsylvania
Research Site
Fort Sam Houston
Texas
Research Site
Spokane
Washington
Research Site
Tacoma
Washington
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
Goiânia
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
São Paulo
Brazil
Research Site
São Paulo
Brazil
Research Site
São Paulo
Brazil
+ 130 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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