JPRN-jRCT2080224959已完成1 期
A Phase 1/2 Study of Zanubrutinib in Japanese Patients With Mature B-Cell Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 62
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Participants with Confirmed diagnosis of mature B-cell neoplasms including chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma and Waldenstrom's macroglobulinemia
- •- Relapsed/refractory disease defined as disease that relapsed after, or been refractory to, at least 1 prior therapy
- •- Meeting at least one of criteria for requiring treatment
- •- Measurable disease by computed tomography (CT)/ magnetic resonance imaging (MRI) for mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) and follicular lymphoma (FL) participants and by serum immunoglobulin (Ig) M level > 0.5 g/dL for WM participants
- •- Eastern Cooperative Oncology Group performance status of 0, 1, or 2
- •- Life expectancy of > 4 months
排除标准
- •- Known central nervous system involvement by lymphoma/leukemia
- •- Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter's syndrome
- •- Prior allogeneic stem cell transplant
- •- Systemic chemotherapy or radiation therapy within 2 weeks prior to first dose of zanubrutinib
- •- Active fungal, bacterial, and/or viral infection requiring systemic therapy
- •- Prior therapy with B-cell receptor inhibitor (eg, Bruton tyrosine kinase, phosphoinositide 3 kinase delta, and/or spleen tyrosine kinase inhibitor) or B-cell lymphoma 2 inhibitor (eg, venetoclax/ABT-199)
- •- Pregnant, lactating, or nursing women
- •- Autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy
研究者
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