At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 68 enrolled
Drug / intervention
Zanubrutinibdrug
Likely dose
Zanubrutinib 160 mg orally twice a dayAI-extracted
Key inclusion· 9
- ✓Age 18 years or older
- ✓Histologically confirmed marginal zone lymphoma (splenic, nodal, or extranodal subtypes)
- ✓Relapsed or refractory after at least one prior line of therapy including a CD20-directed regimen with documented failure to achieve partial response or progressive disease
- ✓Current need for systemic therapy for MZL
Key exclusion· 13
- ✕Known transformation to aggressive lymphoma (e.g., large cell lymphoma)
- ✕Clinically significant cardiovascular disease
- ✕Prior malignancy within past 2 years (except curatively treated skin cancer, superficial bladder cancer, cervical/breast carcinoma in situ, or localized prostate cancer)
- ✕History of severe bleeding disorder (hemophilia A/B, von Willebrand disease) or spontaneous bleeding requiring transfusion
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Open-label Study of Zanubrutinib (BGB-3111) in Patients With Relapsed or Refractory Marginal Zone Lymphoma
In Brief
A Phase 2 clinical trial evaluating Zanubrutinib for Marginal Zone Lymphoma and MZL. Completed, enrolled 68 participants across 31 sites in 9 countries.
Detailed Summary
This is a single arm study to evaluate the efficacy, safety and tolerability of zanubrutinib (BGB-3111) in participants with relapsed/refractory marginal zone lymphoma (R/R MZL).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMarginal Zone Lymphoma, MZL
CountriesAustralia, China, Czechia, France, Italy, New Zealand, South Korea, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedFeb 2019
Enrollment StartFeb 2019
Primary CompletionMay 2022
TodayJul 2026
First PostedFeb 19, 2019
Enrollment StartFeb 19, 2019
Primary CompletionMay 4, 2022
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 7.4 years ago
Interventions
Zanubrutinibdrug
Zanubrutinib at a dose of 160 mg orally twice a day (BID)