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)
Who is this study for? Adult patients with Chronic Lymphocytic Leukemia
Status: Active_not_recruiting
Location: See all (164) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 130
Healthy Volunteers: f
View:
• 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.
Locations
United States
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Cambridge
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Canterbury
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Wolverhampton
Time Frame
Start Date: 2019-02-25
Completion Date: 2027-01-31
Participants
Target number of participants: 984
Treatments
Experimental: Acalabrutinib, Venetoclax
Acalabrutinib in combination with Venetoclax
Experimental: Acalabrutinib, Venetoclax, Obinutuzumab
Acalabrutinib in combination with Venetoclax with Obinutuzumab
Active_comparator: Chemoimmunotherapy
Chemoimmunotherapy~FCR: Fludarabine, Cyclophosphamide and Rituximab~BR: Bendamustine and Rituximab
Related Therapeutic Areas
Sponsors
Leads: Acerta Pharma BV
Collaborators: AstraZeneca