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NCT Number: NCT04170283

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

B-cell Malignancies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Paratus Clinical Research Woden, Canberra, Australian Capital Territory, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Currently participating or participated recently in a BeiGene parent study
  • Intent to continue or start zanubrutinib treatment after any of the following:
  • At time of final analysis or study closure of the eligible BeiGene parent study
  • At time of progressive disease (PD); and investigator, patient and medical monitor agree it is in the patient's best interest
  • At an alternative timepoint for an alternative reason
  • Patient who is currently on zanubrutinib treatment:

Does not meet any protocol-specified criteria for zanubrutinib hold or permanent discontinuation, and, in the opinion of the investigator, will continue to benefit from zanubrutinib treatment

  • Zanubrutinib-naive patient:

Must meet the following criteria ≤ 15 days before first dose of study drug:

  • Platelets ≥ 50,000/mm3
  • Absolute neutrophil count ≥ 750/mm3
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal
  • Serum total bilirubin ≤ 3 x upper limit of normal (not required for Gilbert Syndrome)
  • QT interval corrected for heart rate using Fridericia's formula (QTcF) ≤ 480 msec
  • No known New York Heart Association (NYHA) Class III or IV congestive heart failure
  • Creatinine clearance ≥ 30 mL/min
  • Female participants of childbearing potential and nonsterile males must be willing to use a highly effective method of birth control.

Key Exclusion Criteria:

  • Permanently discontinued from zanubrutinib treatment in the BeiGene parent study due to unacceptable toxicity, non-compliance with study procedures, or withdrawal of consent
  • Uncontrolled active systemic infection or recent infection requiring parenteral anti-microbial therapy
  • Life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of zanubrutinib, or put the study outcomes at undue risk
  • Concomitant chemotherapy, targeted therapy, radiation therapy, antibody-based therapies, or any prohibited concomitant therapy outlined in the protocol
  • Pregnant or lactating woman
  • Inability to comply with study procedures
  • Concurrent participation in another therapeutic clinical study
  • History of progressive disease (PD) while receiving a BTK inhibitor (excluding zanubrutinib)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Treatment and study plan

Zanubrutinib

Drug

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.

Other names: BGB-3111

Tislelizumab

Drug

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..

Other names: BGB-A317

Primary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Up to 5 years

    Safety as assessed by incidence of all treatment-emergent adverse events (TEAEs) and serious AEs (SAEs)

Secondary outcomes

  1. Progression-Free Survival (PFS) per investigator assessment

    Time frame: Up to 5 years

    Time from the starting date of zanubrutinib in the eligible BeiGene study to the date of first documentation of disease progression or death, whichever occurs first

  2. Duration of Response (DOR) per investigator assessment

    Time frame: Up to 5 years

    Time from the date that response criteria are first met after the start of zanubrutinib in the eligible BeiGene study to the date that progressive disease (PD) is objectively documented or death, whichever occurs first

  3. Overall Survival (OS)

    Time frame: Up to 5 years

    Time from the starting date of zanubrutinib in the eligible BeiGene study to the date of death due to any reason

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2027
Study completion
2028
First posted
Nov 20, 2019
Registry last updated
Oct 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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