NCT02844309已完成4 期
The Efficacy of Thalidomide Plus Cyclophosphamide and Dexamethasone Following by Thalidomide and Prednisone Maintenance Therapy for the Newly Diagnosed Waldenström Macroglobulinemia - a Prospective Multicentre Phase Ⅳ Trial From China
Institute of Hematology & Blood Diseases Hospital, China1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2016年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
The purpose of this study is to evaluate the efficiency of an oral regimen in newly diagnosed Waldenström macroglobulinemia: thalidomide plus cyclophosphamide and dexamethasone following by thalidomide and prednisone maintenance therapy.
详细描述
Enrolled patients will accept maximum 8 cycles of thalidomide plus cyclophosphamide and dexamethasone. if a partial remission response or better is achieved, thalidomide plus prednisone maintenance therapy will be given for no more than two years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 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 centre 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
Thalidomide
Experimental
thalidomide 50-150mg per night
干预措施: Thalidomide (Drug)
结局指标
主要结局
Overall response rate
时间窗: up to 12 months
次要结局
- progress-free survival(up to 36 months)
研究者
Yi Shuhua
Principal Investigator
Institute of Hematology & Blood Diseases Hospital, China
研究点 (1)
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