NCT00302861终止1 期
Phase 1/2 Study to Evaluate the Feasibility and Tolerability of Treatment of Previously Untreated B-CLL Chronic Lymphocytic Leukemia (B-CLL) Patients With Recombinant Idiotype Conjugated to KLH (Id-KLH) Administered With GM-CSF
Genitope Corporation0 个研究点目标入组 86 人开始时间: 2006年3月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 86
- 主要终点
- The proportion of patients with positive humoral immune responses
研究概览
简要总结
This is a multi-center, open-label, single arm Phase 1/2 study evaluating the feasibility, safety, and tolerability of a series of 16 immunizations of Id-KLH with GM-CSF in patients with previously untreated B-CLL. The length of the controlled portion of the study is two years. The study will be conducted at investigative sites in the United States.
研究设计
- 研究类型
- Interventional
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
- •Have signed a written informed consent
- •B-CLL diagnosis
- •Rai Stage 0, I, or II
- •Previously untreated
- •Be able to watch and wait for approximately 8 months following submission of blood (or tissue) while Id-KLH is being manufactured
排除标准
- •Anti-leukemia treatment prior to beginning immunization
- •Anti-leukemia treatment other than Id-KLH during immunizations
- •Prior malignancy (excluding basal cell carcinoma and cervical carcinoma in situ)
- •Pregnant or lactating
- •Patients with known autoimmune disease (including previously treated autoimmune hemolytic anemia or immune thrombocytopenia)
- •Participation in any other clinical trial in which an investigational agent is administered
结局指标
主要结局
The proportion of patients with positive humoral immune responses
Safety and toxicity
次要结局
未报告次要终点
研究者
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