At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 16 enrolled
Drug / intervention
Ibrutinib +1 moredrug
Likely dose
Ibrutinib 420 mgfrom 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.
Phase 2 Study of Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib (PCI-32765) in Combination With Rituximab, in Japanese Patients With Waldenstrom's Macroglobulinemia (WM)
In Brief
A Phase 2 clinical trial evaluating Ibrutinib and Rituximab for Waldenstrom Macroglobulinemia. Completed, enrolled 16 participants across 9 sites.
Detailed Summary
The purpose of this study is to evaluate overall response rate (ORR) by Independent Review Committee (IRC) assessment, when combined with rituximab in Japanese participants with treatment naïve or relapsed/refractory Waldenstrom's Macroglobulinemia (WM).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWaldenstrom Macroglobulinemia
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedAug 2019
Enrollment StartSep 2019
Primary CompletionAug 2021
Study CompletionMar 2023
TodayJul 2026
First PostedAug 20, 2019
Enrollment StartSep 25, 2019
Primary CompletionAug 24, 2021
Study CompletionMar 2, 2023
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 6.9 years ago
Interventions
Ibrutinibdrug
Ibrutinib 420 mg will be administered orally.
Rituximabdrug
Rituximab 375 mg/m\^2 will be administered intravenously.