At a glance
ClinicalIndex Comparison RecordPhase 3Active· 310 enrolled
Drug / intervention
Acalabrutinib (ACP-196) +3 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, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator's Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects With R/R Chronic Lymphocytic Leukemia
In Brief
A Phase 3 clinical trial evaluating Acalabrutinib (ACP-196), Rituximab, and 2 other interventions for Chronic Lymphocytic Leukemia. Active but no longer recruiting, targeting 310 participants across 157 sites in 25 countries.
Detailed Summary
This study is designed to evaluate the efficacy of acalabrutinib compared with rituximab in combination with idelalisib or bendamustine in previously treated subjects with chronic lymphocytic leukemia (CLL).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Lymphocytic Leukemia
CountriesAustralia, Austria, Belgium, Bulgaria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Hungary, Israel, Italy, New Zealand, Poland, Russia, Singapore, Slovakia, South Korea, Spain, Sweden, Taiwan, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3Active
201720182019202020212022202320242025202620272028
First PostedNov 2016
Enrollment StartFeb 2017
Primary CompletionSep 2021
TodayJul 2026
Study CompletionOct 2027
First PostedNov 22, 2016
Enrollment StartFeb 2, 2017
Primary CompletionSep 3, 2021
Study CompletionOct 1, 2027
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 9.6 years ago
Interventions
Acalabrutinib (ACP-196)drug
Acalabrutinib monotherapy
Rituximabdrug
Rituximab in combination with idelalisib or bendamustine
Idelalisibdrug
Idelalisib in combination with rituximab
Bendamustinedrug
Bendamustine in combination with rituximab