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Trial record 12 of 33 for:    BGB-3111

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04170283
Recruitment Status : Enrolling by invitation
First Posted : November 20, 2019
Last Update Posted : August 5, 2020
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
B-cell Malignancies Drug: Zanubrutinib Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multi-center, Long-term Extension Study of Zanubrutinib (BGB-3111) in Patients With B-cell Malignancies
Actual Study Start Date : January 21, 2020
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2025

Arm Intervention/treatment
Experimental: Zanubrutinib (BGB-3111)
All participants to receive open-label zanubrutinib
Drug: Zanubrutinib
Participants will receive zanubrutinib at a dose of 160 mg twice daily (for a total daily dose of 320 mg), or the equivalent last dose level received in the BeiGene parent study.
Other Name: BGB-3111

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  1. As part of the BeiGene parent study:

    1. Currently participating, or
    2. Participated recently
  2. Must meet the following criteria within < or = 15 days before first dose of study drug (Zanubrutinib):

    1. Platelets ≥ 50,000/mm3
    2. Absolute neutrophil count ≥ 750/mm3
    3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 x upper limit of normal
    4. Serum total bilirubin ≤ 3 x upper limit of normal (not required for cases with documented Gilbert Syndrome)
    5. QT interval corrected for heart rate using Fridericia's formula (QTcF) ≤ 480 msec; site to provide copy of ECG tracing and rhythm
    6. No known New York Heart Association Class III or IV congestive heart failure
    7. Creatinine clearance ≥ 30 mL/min (as estimated by the Cockcroft-Gault equation based on ideal body weight or estimated glomerular filtration rate [eGFR] from the Modification of Diet in Renal Disease [MDRD])

Key Exclusion Criteria:

  1. Permanently discontinued from zanubrutinib treatment in the BeiGene parent study due to unacceptable toxicity, non-compliance with study procedures, or withdrawal of consent
  2. Uncontrolled active systemic infection or recent infection requiring parenteral anti-microbial therapy
  3. 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
  4. Concomitant chemotherapy, targeted therapy, radiation therapy, antibody-based therapies, or any prohibited concomitant therapy outlined in the protocol
  5. Pregnant or lactating woman
  6. Inability to comply with study procedures
  7. Concurrent participation in another therapeutic clinical study
  8. History of progressive disease (PD) while receiving a BTK inhibitor (excluding zanubrutinib)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04170283

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Sponsors and Collaborators
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Study Director: Rainer K. Brachmann, MD BeiGene
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Responsible Party: BeiGene Identifier: NCT04170283    
Other Study ID Numbers: BGB-3111-LTE1
First Posted: November 20, 2019    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BeiGene:
Bruton's tyrosine kinase (BTK) inhibitor
long-term extension
Additional relevant MeSH terms:
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Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action