NCT00517218撤回3 期
A Randomized Phase 3 Study of Fludarabine and Rituximab With or Without Genasense® (Oblimersen Sodium) in Previously Untreated Subjects With Chronic Lymphocytic Leukemia
Genta Incorporated0 个研究点开始时间: 2006年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
研究概览
简要总结
To compare the efficacy and safety of combination treatment with Genasense, fludarabine, and rituximab versus combination treatment with fludarabine and rituximab in previously untreated subjects with CLL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Previously untreated subjects with intermediate-or high-risk CLL(modified Rai Stages I-IV)
- •Measurable disease as primarily established by the National Cancer Institute-sponsored Working Group(NCI-WG) Guidelines for the diagnosis of CLL
- •Requiring therapy for active disease, as primarily defined by the NCI-WG Guidelines
- •Eastern Cooperative Oncology Group Performance Status < 2
- •Adequate organ function determined , 14 days prior to the first dose of study medication
排除标准
- •Absolute Lymphocyte count > 100,000/uL
- •Prior chemotherapy or other therapy for CLL, including allogeneic transplant
- •Less than 3 weeks from any prior major surgery at the time of informed consent
- •Failure to recover from any serious adverse effect of surgery
- •History of autoimmune hemolytic anemia or autoimmune thrombocytopenia
- •Active serious infection requiring systemic anti-infective therapy
研究者
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