JPRN-jRCT2021210055进行中（未招募）2 期
A Phase 2 Study of the Safety and Efficacy of Venetoclax in Combination with Obinutuzumab or Ibrutinib in Japanese Subjects with Previously Untreated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Okubo Sumiko0 个研究点目标入组 20 人开始时间: 2021年11月26日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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
- •Adult male or female, at least 65 years old; or 20 to 64 years old and have at least 1 of the following:
- •-- Cumulative Illness Rating Scale (CIRS) score > 6.
- •-- Creatinine clearance (CrCl) estimated < 70 mL/min using Cockcroft-Gault equation.
- •- Must have measurable nodal disease (by computed tomography [CT]), defined as at least one lymph node
- •> 1.5 cm in longest diameter.
- •- Diagnosed Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) that
- •requires treatment according to the Modified 2008 International Workshop on Chronic Lymphocytic
- •Leukemia (iwCLL) criteria
排除标准
- •- Transformation of Chronic Lymphocytic Leukemia (CLL) to aggressive non-Hodgkin lymphoma (NHL;
- •Richter's transformation or pro-lymphocyticleukemia).
- •- Previous treatment history for CLL/SLL.
研究者
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