A Single-Arm, Expanded Access Study of Zanubrutinib (BGB3111) in Patients With B-cell Malignancies
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
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
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)
Prior exposure to a 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