At a glance
ClinicalIndex Comparison RecordPhase 3Active· 533 enrolled
Drug / intervention
Acalabrutinib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase III Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Subjects With High Risk Chronic Lymphocytic Leukemia
In Brief
A Phase 3 clinical trial evaluating Acalabrutinib and Ibrutinib for Chronic Lymphocytic Leukemia. Active but no longer recruiting, targeting 533 participants across 130 sites in 15 countries.
Detailed Summary
This study is designed to evaluate progression-free survival (PFS) endpoint for acalabrutinib versus (vs) ibrutinib in previously treated chronic lymphocytic leukemia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Lymphocytic Leukemia
CountriesAustralia, Belgium, Denmark, France, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Poland, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3Active
2016201720182019202020212022202320242025202620272028
First PostedJun 2015
Enrollment StartJul 2015
Primary CompletionSep 2020
TodayJul 2026
Study CompletionJan 2028
First PostedJun 23, 2015
Enrollment StartJul 28, 2015
Primary CompletionSep 15, 2020
Study CompletionJan 3, 2028
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 11.0 years ago
Interventions
Acalabrutinibdrug
Participants will receive oral acalabrutinib as stated in arm description.
Ibrutinibdrug
Participants will receive oral ibrutinib as stated in arm description.