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

Study Overview
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Brief Summary
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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

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

Conditions
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Waldenström Macroglobulinemia

Intervention / Treatment
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* Drug: Zanubrutinib


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: 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 Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 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 Creatinine clearance of ≥ 30 mL/min Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≤ 3 x upper limit of normal (ULN) Total bilirubin level ≤ 2 x ULN (unless documented Gilbert's syndrome) Key Exclusion Criteria: Prior exposure to a Bruton tyrosine kinase (BTK) inhibitor Evidence of disease transformation at the time of study entry Ongoing requirement for systemic corticosteroid other than systemic adrenal replacement therapy Chemotherapy given with antineoplastic intent, targeted therapy, radiation therapy or antibody-based therapy within 4 weeks of the start of study drug Ongoing toxicity of ≥ Grade 2 from prior anticancer therapy Prior or concurrent active malignancy within the past 2 years Clinically significant cardiovascular disease Unable to swallow capsules or disease significantly affecting gastrointestinal function Active fungal, bacterial and/or viral infection requiring systemic therapy Known infection with HIV, or serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection as follows Pregnant or lactating women History of stroke or intracranial hemorrhage within 180 days before first dose of study drug History of severe bleeding disorder Active central nervous system (CNS) involvement by WM and/or lymphoma NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Zanubrutinib|Zanubrutinib will be orally administered in participants with treatment naive or R/R WM|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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WM, Treatment naive, Relapsed/refractory