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Trials / Active Not Recruiting

Active Not RecruitingNCT04170283

Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Participants With B-cell Malignancies

An Open-label, Multi-center, Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Patients With B-cell Malignancies

Status
Active Not Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
955 (actual)
Sponsor
BeiGene · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to evaluate the long-term safety of zanubrutinib regimens in participants with B-cell malignancies who participated in a BeiGene parent study for zanubrutinib.

Conditions

Interventions

TypeNameDescription
DRUGZanubrutinibParticipants will receive zanubrutinib at a dose of 160 mg twice daily (for a total daily dose of 320 mg), or the last dose level received in the BeiGene parent study.
DRUGTislelizumabPatients in Australia who participated in a parent study that involved combination therapy of zanubrutinib and tislelizumab will receive tislelizumab at a dose of 200mg every 3 weeks..

Timeline

Start date
2020-01-16
Primary completion
2027-11-01
Completion
2028-12-01
First posted
2019-11-20
Last updated
2025-10-21

Locations

152 sites across 17 countries: United States, Australia, China, Czechia, France, Germany, Greece, Italy, Japan, Netherlands, New Zealand, Poland, South Korea, Spain, Sweden, Turkey (Türkiye), United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT04170283. Inclusion in this directory is not an endorsement.