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Trial record 18 of 22 for:    BGB-3111

A Single-Arm, Expanded Access Study of Zanubrutinib (BGB3111) in Patients 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04052854
Expanded Access Status : Available
First Posted : August 12, 2019
Last Update Posted : August 12, 2019
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Mantle Cell Lymphoma Waldenström Macroglobulinemia Drug: Zanubrutinib

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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
Official Title: A Single-Arm, Expanded Access Study of Zanubrutinib (BGB3111) in Patients With B-cell Malignancies

Intervention Details:
  • Drug: Zanubrutinib
    Zanubrutinib (BGB-3111) will be orally administered in patients with relapsed/refractory (R/R) MCL and patients with treatment naive or R/R WM

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  1. Histologically confirmed diagnosis of MCL (based on the World Health Organization (WHO) 2008 classification) who have relapsed from or who are refractory to at least one prior therapy; OR 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)

Exclusion Criteria:

  1. Prior exposure to a 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 CNS involvement by WM and/or lymphoma

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): NCT04052854

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Contact: BeiGene, Ltd. c/o BeiGene USA, Inc. 877 828 5568

Sponsors and Collaborators

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Responsible Party: BeiGene Identifier: NCT04052854     History of Changes
Other Study ID Numbers: BGB-3111-216
First Posted: August 12, 2019    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019

Keywords provided by BeiGene:
Treatment naive

Additional relevant MeSH terms:
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Lymphoma, Mantle-Cell
Waldenstrom Macroglobulinemia
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action