Autologous Stem-cell Transplantation Versus Conventional Chemotherapy for High Risk Waldenström Macroglobulinemia - a Prospective Multicentre Phase Ⅳ Trial From China
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 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 evaluate whether autologous stem cell transplantation will improve the survival of patients with high-risk Waldenström macroglobulinemia, compared with conventional chemotherapy.
详细描述
WM patients with partial response after introduction chemotherapy will be recommended to adopt autologous stem cell transplantation or receive conventional chemotherapy (dependent on patient's choices). After transplantation or conventional chemotherapy, maintenance therapy with rituximab or thalidomide plus prednisone will be given for less than two years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •70 years>=Aged >=18 years
- •diagnosed with high-risk LPL/WM according to the ISSWM criteria
- •untreated or mild treated without standard regimens
- •suitable for ASCT
- •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
autologous stem cell transplantation
Patients in this group will receive BEAC(BCNU+VP-16+CTX+Ara-c) as conditioning regimen and then with autologous stem cells feedback
干预措施: autologous stem cell transplantation (Procedure)
conventional chemotherapy
Patients in this group will receive previously effective chemotherapeutic regimen as consolidation therapy
干预措施: conventional chemotherapy (Drug)
结局指标
主要结局
progress-free survival
时间窗: up to 36 months
次要结局
- complete remission rate(up to 12 months)
研究者
Yi Shuhua
Principal Investigator
Institute of Hematology & Blood Diseases Hospital, China