NCT00022685Unknown3 期
A Phase III Clinical Trial of Immunotherapy With Humanized LL2 IgG (Epratuzumab) in Patients With Low-Grade Follicular, B-Cell Non-Hodgkin's Lymphoma Refractory to Rituxan (Rituximab)
适应症
试验速览
- 阶段
- 3 期
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Monoclonal antibodies such as epratuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase III trial to determine the effectiveness of epratuzumab in treating patients who have low-grade non-Hodgkin's lymphoma that has not responded to chemotherapy or rituximab.
详细描述
OBJECTIVES:
- Determine the safety of epratuzumab in patients with rituximab-refractory low-grade follicular B-cell non-Hodgkin's lymphoma.
- Confirm the convenient administration of this drug in this patient population.
- Determine the efficacy of this drug in terms of objective response rate in these patients.
- Determine the duration of response and time to progression in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive epratuzumab IV over 15-60 minutes on days 1, 8, 15, and 22.
Patients are followed every 8 weeks for 10 months and then every 3 months for up to 4 years.
研究设计
- 研究类型
- Interventional
- 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
- 未提供
排除标准
- 未提供
研究者
研究点 (2)
Loading locations...
相似试验
撤回
3 期
Trastuzumab With or Without Tamoxifen in Treating Women With Progressive Stage IV Breast CancerStage IV Breast CancerRecurrent Breast CancerNCT00053339Alliance for Clinical Trials in Oncology
已完成
3 期
Monoclonal Antibody Therapy in Treating Patients With Follicular or Mantle Cell LymphomaLymphomaNCT00003280Swiss Cancer Institute240
Unknown
2 期
Epratuzumab in Treating Patients With Non-Hodgkin's LymphomaLymphomaNCT00042913Jonsson Comprehensive Cancer Center
已完成
2 期
Trastuzumab Plus Docetaxel in Treating Women With Recurrent or Metastatic Breast CancerBreast CancerNCT00006104Vanderbilt-Ingram Cancer Center46
已完成
2 期
Trastuzumab Plus Paclitaxel in Treating Women With Metastatic Breast Cancer That Overexpresses HER2Breast CancerNCT00005635Genentech, Inc.