Velcade/Dexamethasone/Cyclophosphamide(PCD) Versus Rituximab /Dexamethasone/Cyclophosphamide(RCD) for the Treatment of Patients With Waldenstrom's Macroglobulinemia
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Investigators try to compare the complete remission (CR) rates at the end of the research.
研究概览
简要总结
Patients will receive RCD or PCD combination as induction treatment followed by rituximab or velcade maintenance therapy, as the investigators try to compare the, very good partial remission (VGPR) rate, complete remission (CR) rates, Overall remission rate (MR+CR + VGPR + partial remission (PR) rate), major reaction rate (MRR, PR+VGPR+CR) at the end of the research.
详细描述
This is an open-label, single-centre, randomised study, looking at a series of 40 patients up to the age of 75 with newly diagnosed Waldenstrom's macroglobulinemia (WM) not previously treated. Patients will receive RCD or PCD combination as induction treatment followed by rituximab or velcade maintenance therapy, as the investigators try to compare the, very good partial remission (VGPR) rate, complete remission (CR) rates, Overall remission rate (MR+CR + VGPR + partial remission (PR) rate), major reaction rate (MRR, PR+VGPR+CR) at the end of the research.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recently diagnosed WM according to the second 2002 WM international working group
- •Not previously treated, apart from not regularly received by Chlorambucil
- •Aged from 18 to 75 years, both male and female
- •Ability to give signed informed consent
- •Negative pregnancy test at inclusion (if necessary)
- •ECOG from 0 to 2
排除标准
- •Known hypersensitivity to rituximab or velcade or cyclophosphamide
- •Uncontrolled infection including bacteria, virus and fungus, including active HBV infection
- •Organic dysfunction: Bilirubin > 1.5 x normal above, Renal failure requiring dialysis, glutamic pyruvic transaminase (ALT) and Glutamic-Oxaloacetic Aminotransferase (AST) > 2.5 x normal above
- •Positive HIV serology
- •Serious psychiatric item in the history
研究组 & 干预措施
rituximab /Dex/CTX
rituximab /Dexamethasone/cyclophosphamide 6 cycles followed by rituximab (at least 2 cycles) rituximab:375mg/m2 d1 Dexamethasone:40mg d1-4 cyclophosphamide:750mg/m2,d1-28
干预措施: rituximab /Dexamethasone/cyclophosphamide (Drug)
Velcade/Dex/CTX
Velcade/Dexamethasone/cyclophosphamide 6 cycles followed by velcade (at least 2 cycles) Velcade:1.3mg/m2 d1,d4,d8,d11 Dexamethasone:20mg d1-2,d4-5,d8-9,d11-12 cyclophosphamide:750mg/m2,d1-28
干预措施: Velcade/Dexamethasone/cyclophosphamide (Drug)
结局指标
主要结局
Investigators try to compare the complete remission (CR) rates at the end of the research.
时间窗: 2 years
Investigators try to compare the very good partial remission (VGPR) rate at the end of the research.
时间窗: 2 years
Investigators try to compare major reaction rate (MRR, PR+VGPR+CR) at the end of the research.
时间窗: 2 yeas
Investigators try to compare Overall remission rate (MR+CR + VGPR + partial remission (PR) rate) at the end of the research.
时间窗: 2 years
次要结局
未报告次要终点