The Efficacy of Cyclophosphamide Plus Dexamethasone Combinated With Rituximab or Bortezomib for the Newly Diagnosed Waldenström Macroglobulinemia - a Prospective Multicentre Randomized Control Trial From China
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- progress-free survival
研究概览
简要总结
The purpose of this study is to compare the efficacy of cyclophosphamide plus dexamethasone combined with rituximab or bortezomib regimens in newly diagnosed Waldenström macroglobulinemia patients.
详细描述
Newly diagnosed WM patients will be randomly assigned to BCD or RCD group for introduction chemotherapy. Chemotherapeutic response will be evaluated after 3 cycles. If a PR or better response achieves, addition 3 cycles will be given. If not, patients will be crossed to control group for another 3 cycles. If a PR or better response comes out, addition 3 cycles will be given, otherwise, the patients will quit this study.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged >=18 years
- •diagnosed with LPL/WM
- •untreated or mild treated without standard regimens,especially untreated with rituximab and/or bortezomib
- •symptom patients
- •with life-expectancy more than 3 months.
排除标准
- •diagnosed with other malignancies outside B-NHL within one year(including active center neural system lymphoma)
- •transformed lymphoma
- •liver or renal function lesion unrelated to lymphoma
- •serious complications such as uncontrolled diabetes,gastric ulcer or other serious angiocardiopathy determined by the physician
- •HIV positive or active HBV infection or other uncontrolled systematic infection
- •clinical central nervous dysfunction
- •serious surgery within 30 days
- •pregnancy or baby nursing period or un-contracepted child-bearing period woman;
- •allergy to the trail drugs.
研究组 & 干预措施
Bortezomib
Patients in this group will receive bortezomib+ cyclophosphamide+ dexamethasone as introduction chemotherapy regimen. Chemotherapeutic response will be evaluated after 3 cycles. If a MR or better response achieves, addition 3 cycles will be given. If not, patients will cross to RCD group for another 3 cycles. If a MR or better response comes out, addition 3 cycles will be given, otherwise, the patient will quit this study.
干预措施: Bortezomib (Drug)
rituximab
Patients in this group will receive rituximab+cyclophosphamide+ dexamethasone as introduction chemotherapy regimen. Chemotherapeutic response will be evaluated after 3 cycles. If a MR or better response achieves, addition 3 cycles will be given. If not, patients will cross to BCD group for another 3 cycles. If a MR or better response comes out, addition 3 cycles will be given, otherwise, the patient will quit this study.
干预措施: Rituximab (Drug)
结局指标
主要结局
progress-free survival
时间窗: up to 36 months
次要结局
- Overall response rate(up to 12 months)
研究者
Yi Shuhua
Principal Investigator
Institute of Hematology & Blood Diseases Hospital, China