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

NCT04170283 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 955

Last updated 2025-10-21

No results posted yet for this study

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

DRUG

Zanubrutinib

Participants 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.

DRUG

Tislelizumab

Patients 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..

Sponsors & Collaborators

  • BeiGene

    lead INDUSTRY

Principal Investigators

  • Study Director · BeiGene

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-16
Primary Completion
2027-11-30
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China
  • Czechia
  • France
  • Germany
  • Greece
  • Italy
  • Japan
  • Netherlands
  • New Zealand
  • Poland
  • South Korea
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04170283 on ClinicalTrials.gov