At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 17 enrolled
Drug / intervention
Ibrutinibdrug
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.
A Single Arm, Multicenter, Phase 4 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib (PCI-32765) in Chinese Subjects With Relapse or Refractory Waldenström's Macroglobulinemia
In Brief
A Phase 4 clinical trial evaluating Ibrutinib for Waldenstrom Macroglobulinemia. Completed, enrolled 17 participants across 6 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy of ibrutinib based on overall response rate (ORR) (partial response \[PR\] or better) by investigator assessment per the modified Consensus Response Criteria from the Sixth International Workshop on Waldenstrom's Macroglobulinemia (IWWM) (NCCN 2019), in Chinese participants with relapsed or refractory waldenstrom's macroglobulinemia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWaldenstrom Macroglobulinemia
CountriesChina
Collaborators--
Timeline
Phase 4CompletedFinished
2020202120222023202420252026
First PostedAug 2019
Enrollment StartDec 2019
Primary CompletionMar 2024
TodayJul 2026
First PostedAug 1, 2019
Enrollment StartDec 18, 2019
Primary CompletionMar 19, 2024
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 6.9 years ago
Interventions
Ibrutinibdrug
Ibrutinib will be administered orally, once daily, at a dose of 420 mg (140 mg\*3 capsules taken together at one time).