NCT02100852已完成1 期
A Multi-center Phase I/Ib Study Evaluating the Efficacy and Safety of TGR-1202, a Novel PI3K Delta Inhibitor, in Combination With Obinutuzumab and Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose acceptable for participants
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in combination with obinutuzumab (Gazyva) and chlorambucil in patients with chronic lymphocytic leukemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Confirmed Chronic Lymphocytic Leukemia (CLL)
- •Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
- •Ability to swallow oral medication
排除标准
- •Known hepatitis B virus, hepatitis C virus or HIV infection
- •Primary central nervous system lymphoma or known intracranial involvement
- •Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months
研究组 & 干预措施
TGR-1202 + Obinutuzumab + Chlorambucil
Experimental
TGR-1202 is an oral daily dose with obinutuzumab at a fixed IV infusion and chlorambucil as an oral dose on specified days.
干预措施: TGR-1202 + Obinutuzumab + Chlorambucil (Drug)
结局指标
主要结局
Maximum Tolerated Dose acceptable for participants
时间窗: 28 days (1 cycle of therapy)
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities
次要结局
- Overall Response Rate(Up to 1 year)
研究者
研究点 (1)
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