Rituximab for Waldenstrom's Macroglobulinemia (WM): A Phase II Pilot Study for Untreated or Previously Treated Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 136
研究概览
简要总结
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have Waldenstrom's macroglobulinemia.
详细描述
OBJECTIVES: I. Determine the response rate in previously treated and previously untreated patients with Waldenstrom's macroglobulinemia receiving rituximab. II. Determine the associated toxicities with this treatment, specifically the frequency of febrile or hypotensive events, in this patient population.
OUTLINE: Patients are stratified according to prior treatment (yes vs no). Patients with prior treatment are further stratified according to type of treatment (alkylating agents vs purine nucleoside analogues). Patients receive rituximab IV over 4 hours on days 1, 8, 15, and 22. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 66 patients (33 per stratum) will be accrued for this study within 36 months.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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