Zanubrutinib (BGB-3111) in Participants With Previously Treated B-Cell Lymphoma Intolerant of Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Treatment

July 17, 2023 updated by: BeiGene

A Phase 2, Multicenter, Single-arm Study of Zanubrutinib (BGB-3111) in Patients With Previously Treated B-Cell Lymphoma Intolerant of Prior Treatment With Ibrutinib and/or Acalabrutinib

The primary objective of this study is to evaluate the safety of zanubrutinib (also known as BGB-3111) in chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenström macroglobulinemia, mantle cell lymphoma, or marginal zone lymphoma patients who have become intolerant of prior ibrutinib and/or acalabrutinib treatment, by comparing intolerance to adverse event profile as assessed by the recurrence and the change in severity of adverse events.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85711
        • Recruiting
        • Arizona Oncology Associates, Pc Hope
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Recruiting
        • Rocky Mountain Cancer Centers (Williams) Usor
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Christiana Care
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Recruiting
        • SCRI Florida Cancer Specialists South
      • Jacksonville, Florida, United States, 32204
        • Recruiting
        • St Century Oncology
      • Saint Petersburg, Florida, United States, 33705
        • Recruiting
        • Scri Florida Cancer Specialists North
    • Illinois
      • Tinley Park, Illinois, United States, 60487
        • Recruiting
        • Healthcare Research Network III, LLC
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Recruiting
        • Minnesota Oncology Burnsville Clinic
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Recruiting
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • Florham Park, New Jersey, United States, 07932
        • Recruiting
        • Summit Medical Group
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Morristown Medical Center
    • New York
      • Westbury, New York, United States, 11590
        • Recruiting
        • Clinical Research Alliance, Inc
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Oncology Associates of Oregon Willamette Valley Cancer Center
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Recruiting
        • St Lukes University Health Network
      • Horsham, Pennsylvania, United States, 19044
        • Recruiting
        • Abington Hematology Oncology Associates
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology, Pllc Nashville
    • Texas
      • Amarillo, Texas, United States, 79106
        • Recruiting
        • Texas Oncology Amarillo
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor Research Institute
      • McAllen, Texas, United States, 78503
        • Recruiting
        • Texas Oncology McAllen South Second Street
      • Tyler, Texas, United States, 75702
        • Recruiting
        • Texas Oncology Tyler Longview
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Us Oncology Virginia Cancer Specialists, Pc
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Research Center
      • Spokane, Washington, United States, 99208
        • Recruiting
        • Medical Oncology Associates
    • Wisconsin
      • Madison, Wisconsin, United States, 53717
        • Recruiting
        • Ssm Health Cancer Care Dean Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Participants must meet protocol defined disease criteria requiring treatment for their respective disease prior to initiation of ibrutinib or acalabrutinib

  2. Ibrutinib and acalabrutinib intolerance is defined as an unacceptable toxicity where, in the opinion of the investigator, treatment should be discontinued in spite of optimal supportive care as a result of one of the following:

    1. For ibrutinib and acalabrutinib intolerance events:

      • 1 or more ≥ Grade 2 nonhematologic toxicities for >7 days (with or without treatment)
      • 1 or more ≥ Grade 3 nonhematologic toxicity of any duration
      • 1 or more Grade 3 neutropenia with infection or fever of any duration; or
      • Grade 4 heme toxicity which persists to the point that the investigator chose to stop therapy due to toxicity NOT progression.

    2. For acalabrutinib intolerance events only;

      • 1 or more ≥ Grade 1 nonhematologic toxicities of any duration with > 3 recurrent episodes; or
      • 1 or more ≥ Grade 1 nonhematologic toxicities for > 7 days (with or without treatment); or
      • Inability to use acid-reducing agents or anticoagulants (eg, proton pump inhibitors, warfarin) due to concurrent acalabrutinib use
  3. Ibrutinib and/or acalabrutinib-related ≥ Grade 2 toxicities must have resolved to ≤ Grade 1 or baseline prior to initiating treatment with zanubrutinib. Grade 1 acalabrutinib-related toxicities must have resolved to Grade 0 or baseline prior to initiating treatment with zanubrutinib.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  5. Absolute neutrophil count (ANC) ≥ 1000/mm^3 with or without growth factor support and platelet count ≥ 50,000/mm^3 (may be post-transfusion), on or prior to C1D1 of zanubrutinib

Key Exclusion Criteria:

  1. Clinically significant cardiovascular disease including the following:

    1. Myocardial infarction within 6 months before the Screening
    2. Unstable angina within 3 months before the Screening
    3. New York Heart Association class III or IV congestive heart failure
    4. History of sustained ventricular tachycardia, ventricular fibrillation, and/or Torsades de Pointes
    5. QT interval corrected by Fridericia's formula > 480 milliseconds
    6. History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place
  2. History of central nervous system (CNS) hemorrhage
  3. Documented progressive disease (PD) during ibrutinib and/or acalabrutinib treatment.
  4. Have received any anticancer therapy (other than immunotherapy) for CLL/SLL, WM, MCL, and MZL < 7 days before any Screening assessments are performed or any immunotherapy treatment, taken alone or as part of a chemoimmunotherapy regimen, < 4 weeks before any Screening assessments are performed
  5. Requires ongoing need for corticosteroid treatment > 10 mg daily of prednisone or equivalent corticosteroid. Note: Systemic corticosteroids must be fully tapered off/discontinued ≥ 5 days before the first dose of study drug is administered.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zanubrutinib

Cohort 1: Chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), or marginal zone lymphoma (MZL) previously treated with ibrutinib

Cohort 2: Chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), or marginal zone lymphoma (MZL) previously treated with acalabrutinib alone/with ibrutinib
Drug: Zanubrutinib
Zanubrutinib (BGB-3111) will be orally administered at a dose of 160 mg twice daily or 320mg once daily until disease progression, unacceptable toxicity, treatment consent withdrawal, or study termination.
Other Names:
  • BGB-3111
  • BRUKINSA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence and change in severity of treatment-emergent Adverse Events (AEs) of interest.
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall response as determined by investigator
Time Frame: 24 months
24 months
Progression free survival (PFS) as determined by investigator
Time Frame: 24 months
24 months
Patient reported outcomes as measured by EuroQol five dimension scale (EQ-5D)
Time Frame: 24 months
24 months
Patient reported outcomes as measured by European Organisation for Research and Treatment of Cancer (EORTC)
Time Frame: 24 months
24 months
Disease control rate as determined by investigator
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BeiGene

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2019

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

October 1, 2019

First Submitted That Met QC Criteria

October 2, 2019

First Posted (Actual)

October 4, 2019

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 17, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BGB-3111-215

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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