Status:
ACTIVE_NOT_RECRUITING
Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL
Lead Sponsor:
Acerta Pharma BV
Collaborating Sponsors:
AstraZeneca
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18-130 years
Phase:
PHASE3
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...
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 with...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2027
Estimated Enrollment :
984 Patients enrolled
Trial Details
Trial ID
NCT03836261
Start Date
February 25 2019
End Date
January 31 2027
Last Update
December 27 2024
Active Locations (170)
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1
Research Site
Los Angeles, California, United States, 90095
2
Research Site
Redondo Beach, California, United States, 90277
3
Research Site
Fort Wayne, Indiana, United States, 46804
4
Research Site
Wichita, Kansas, United States, 67214