NCT01010568终止2 期
Ofatumumab and Bendamustine in Previously Treated Chronic Lymphocytic Leukemia/ Small Lymphocytic Leukemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Overall Response Rate
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the combination of bendamustine and ofatumumab in subjects with relapsed/refractory chronic lymphocytic leukemia and small cell lymphoma. All subjects enrolled on this study will receive both drugs by intravenous (IV) infusion.
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
- •Pathologically confirmed CLL or SLL requiring therapy
- •Age 18 years of age or older
- •ECOG performance status 0, 1, or 2
- •Normal organ and bone marrow function
- •Resolution of toxic effects from prior therapies
- •Ability to adhere to the study schedule and give written informed consent
排除标准
- •Any serious medical, psychiatric illness or laboratory abnormality
- •Chemotherapy or radiotherapy within 4 weeks of entering the study
- •Currently receiving other treatment for CLL/SLL or other malignancies
- •Active other malignancies
- •History of allergic reactions to bendamustine or ofatumumab
- •Ongoing corticosteroid use
- •Pregnant or lactating
- •HIV positive
- •Active hepatitis B
- •Allogeneic transplant within 6 months of entering study or graft-versus-host disease.
研究组 & 干预措施
Ofatumumab and Bendamustine
Experimental
Ofatumumab and Bendamustine
干预措施: Ofatumumab and Bendamustine (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: 6 months
40% per the National Cancer Institute Working Group Response Criteria for Chronic Lymphocytic Leukemia
次要结局
- Complete Response Rate(6 months)
- Median PFS(2 years)
研究者
研究点 (1)
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