A Single-Arm, Expanded Access Study of Zanubrutinib in Participants With B-cell Malignancies

October 21, 2024 updated by: BeiGene

A Single-Arm, Expanded Access Study of Zanubrutinib (BGB3111) in Participants With B-cell Malignancies

This is a multicenter expanded access study of zanubrutinib monotherapy for participants with B-cell malignancies who are ineligible to enroll into any available zanubrutinib clinical trials

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Contacts and Locations

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

Study Locations

  • United States
    • California
      • Rancho Mirage, California, United States, 92270
        • Eisenhower Desert Cardiology Center
      • Santa Barbara, California, United States, 93105
        • Sansum Clinic and Ridley Tree Cancer Center
    • Maryland
      • Columbia, Maryland, United States, 21044
        • Maryland Oncology Hematology, PA
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Morristown Medical Center
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • Westbury, New York, United States, 11590
        • Clinical Research Alliance, Inc
    • Texas
      • Round Rock, Texas, United States, 78681
        • Texas Oncology Austin Midtown
      • Tyler, Texas, United States, 75702
        • Texas Oncology Tyler Longview

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

Key Inclusion Criteria:

  1. Histologically confirmed diagnosis of WM with R/R disease or treatment-naive and considered by their treating physician to be unsuitable for standard chemoimmunotherapy regimens
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  3. Absolute neutrophil count (ANC) ≥ 0.75 x 109/L, independent of growth factor support; and Platelet count ≥ 50 x 109/L, independent of growth factor support or transfusion within 7 days of study entry
  4. Creatinine clearance of ≥ 30 mL/min
  5. Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≤ 3 x upper limit of normal (ULN)
  6. Total bilirubin level ≤ 2 x ULN (unless documented Gilbert's syndrome)

Key Exclusion Criteria:

  1. Prior exposure to a Bruton tyrosine kinase (BTK) inhibitor
  2. Evidence of disease transformation at the time of study entry
  3. Ongoing requirement for systemic corticosteroid other than systemic adrenal replacement therapy
  4. Chemotherapy given with antineoplastic intent, targeted therapy, radiation therapy or antibody-based therapy within 4 weeks of the start of study drug
  5. Ongoing toxicity of ≥ Grade 2 from prior anticancer therapy
  6. Prior or concurrent active malignancy within the past 2 years
  7. Clinically significant cardiovascular disease
  8. Unable to swallow capsules or disease significantly affecting gastrointestinal function
  9. Active fungal, bacterial and/or viral infection requiring systemic therapy
  10. Known infection with HIV, or serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection as follows
  11. Pregnant or lactating women
  12. History of stroke or intracranial hemorrhage within 180 days before first dose of study drug
  13. History of severe bleeding disorder
  14. Active central nervous system (CNS) involvement by WM and/or lymphoma

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?

Collaborators and Investigators

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

Sponsor

BeiGene

Investigators

  • Study Director: Rainer Brachmann, BeiGene

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 Registration Dates

First Submitted

August 8, 2019

First Submitted That Met QC Criteria

August 8, 2019

First Posted (Actual)

August 12, 2019

Study Record Updates

Last Update Posted (Actual)

October 23, 2024

Last Update Submitted That Met QC Criteria

October 21, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BGB-3111-216

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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