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

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ClinicalTrials.gov Identifier: NCT04052854
Expanded Access Status : No longer available
First Posted : August 12, 2019
Last Update Posted : June 10, 2021
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment
Waldenström Macroglobulinemia Drug: Zanubrutinib

Study Design
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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: A Single-Arm, Expanded Access Study of Zanubrutinib (BGB3111) in Participants With B-cell Malignancies

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: Zanubrutinib
    Zanubrutinib will be orally administered in participants with treatment naive or R/R WM
    Other Name: BGB-3111
Eligibility Criteria
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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
Criteria

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.

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): NCT04052854


Locations
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Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Rainer Brachmann BeiGene
More Information
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04052854    
Other Study ID Numbers: BGB-3111-216
First Posted: August 12, 2019    Key Record Dates
Last Update Posted: June 10, 2021
Last Verified: June 2021
Keywords provided by BeiGene:
WM
Treatment naive
Relapsed/refractory
Additional relevant MeSH terms:
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Waldenstrom Macroglobulinemia
Neoplasms
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Zanubrutinib
Tyrosine Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents