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Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens 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.
 
ClinicalTrials.gov Identifier: NCT04170283
Recruitment Status : Enrolling by invitation
First Posted : November 20, 2019
Last Update Posted : July 29, 2022
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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Brief 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.

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

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
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) Regimens 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

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Arms and Interventions
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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 last dose level received in the BeiGene parent study.
Other Name: BGB-3111
Experimental: Zanubrutinib in combination with Tislelizumab
Participants to receive the combination as in the parent study (Australia Only)
 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.
Other Name: BGB-3111

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..
Other Name: BGB-A317


Outcome Measures
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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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  1. Currently participating or participated recently in a BeiGene parent study

  2. Intent to continue or start zanubrutinib treatment after any of the following:

    1. At time of final analysis or study closure of the eligible BeiGene parent study
    2. At time of progressive disease (PD); and investigator, patient and medical monitor agree it is in the patient's best interest
    3. At an alternative timepoint for an alternative reason

  3. 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

  4. Zanubrutinib-naive patient:

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

    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 Gilbert Syndrome)
    5. QT interval corrected for heart rate using Fridericia's formula (QTcF) ≤ 480 msec
    6. No known New York Heart Association (NYHA) Class III or IV congestive heart failure
    7. Creatinine clearance ≥ 30 mL/min
  5. Female participants of childbearing potential and nonsterile males must be willing to use a highly effective method of birth control.

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

Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT04170283


Locations
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Sponsors and Collaborators
BeiGene
More Information
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04170283    
Other Study ID Numbers: BGB-3111-LTE1
First Posted: November 20, 2019    Key Record Dates
Last Update Posted: July 29, 2022
Last Verified: July 2022
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:
Zanubrutinib
Bruton's tyrosine kinase (BTK) inhibitor
long-term extension
Additional relevant MeSH terms:
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Neoplasms
Zanubrutinib
Antineoplastic Agents
 Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action