NCT00233506已完成1 期
A Dose-Finding Study of CpG 7909 in Previously Treated Chronic Lymphocytic Leukemia
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
- 41
- 试验地点
- 2
- 主要终点
- maximum tolerated dose
研究概览
简要总结
- CpG has the potential to stimulate the immune system
- this study will evaluate the safety of CpG given sub-q or IV
- purpose is to measure biological changes in CLL cells after receiving CpG
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Diagnosis of CLL
- •CLL previously treated
- •Hemoglobin >/= 10
- •Platelets >/= 50,000
- •Neutrophils >= 1,000 -
排除标准
- •patients with brain mets
- •patients with autoimmune disease
- •patients on corticosteroids or immunosuppressants
- •patients with uncontrolled intercurrent illness
- •pregnant women
- •HIV patients receiving combination anti-retroviral therapy
研究组 & 干预措施
CPG 7909 IV
Experimental
Intravenous infusions will be administered with a standard infusion pump beginning at 125 cc/hr through an intravenous catheter (central or peripheral).
干预措施: CpG 7909 (Drug)
CPG 7909 SQ
Experimental
Subcutaneous injections should be administered in the abdominal wall, upper arm, hip, or anterior thigh. If the volume of injection exceeds 1.5 ml, the volume should be divided into equal injections at a volume less than 1.5 ml and administered in different areas of the body. The maximum dose level on this trial may require 5 - 6 injections at an equal number of sites.
干预措施: CpG 7909 (Drug)
结局指标
主要结局
maximum tolerated dose
时间窗: at study completion
次要结局
- response(at end of treatment)
研究者
Link, Brian K
Professor
University of Iowa
研究点 (2)
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