NCT04052854No Longer Available不适用
A Single-Arm, Expanded Access Study of Zanubrutinib (BGB3111) in Participants With B-cell Malignancies
BeiGene10 个研究点 分布在 1 个国家开始时间: 2019年8月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
- 试验地点
- 10
研究概览
简要总结
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
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究者
研究点 (10)
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