At a glance
ClinicalIndex Comparison RecordPhase 2Active· 107 enrolled / 107 target
Drug / intervention
Acalabrutinib (ACP-196) +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.
An Open-label, Phase 2 Study of ACP-196 in Subjects With Waldenström Macroglobulinemia
In Brief
A Phase 2 clinical trial evaluating Acalabrutinib (ACP-196) for Waldenström Macroglobulinemia (WM). Active but no longer recruiting, targeting 107 participants across 38 sites in 7 countries.
Signals
Enrollment appears stalled
Detailed Summary
The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and activity of acalabrutinib in treating subjects with WM.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWaldenström Macroglobulinemia (WM)
CountriesFrance, Greece, Italy, Netherlands, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2Active
2015201620172018201920202021202220232024202520262027
First PostedJul 2014
Enrollment StartSep 2014
Primary CompletionOct 2019
TodayJul 2026
Study CompletionDec 2026
First PostedJul 3, 2014
Enrollment StartSep 11, 2014
Primary CompletionOct 1, 2019
Study CompletionDec 31, 2026
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 12.0 years ago
Arms & Interventions
Previously Treatedexperimental
Subjects previously treated with Waldenström Macroglobulinemia N=92
Drug: Acalabrutinib (ACP-196)
Treatment Naïveexperimental
Subjects with treatment-naïve Waldenström Macroglobulinemia. N=14
Drug: Acalabrutinib (ACP-196)
Interventions
Acalabrutinib (ACP-196)drug
Acalabrutinib (ACP-196)drug