A Phase II Trial of Consolidation Chemothetapy for Patients With Relapse or Refractory Lymphoid Malignancies After Autologous Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- progression free survival
研究概览
简要总结
To imporve the outcome of patients with relapsed/refractory lymphoma, we conduct a clinical trial to test the efficacy and feasibility of consolidation chemotherapy after autologous stem cell transplantation
详细描述
Patients with relapsed or refractory lymphoma will be included. All patients will undergo PBSC mobilization with CTX and G-CSF. After sucessful collection of CD34+ over 1x109/L, autologous stem cel ltransplantation with Bu-Cy-E conditioning will be given. Two months after auto-HSCT, a PET-CT will be performed and all patients with CR, CRu and PR will recieved 3 cycles of mini-Bu-Cy-E as consolidation 3, 6 and 9 months after auto-HSCT. For patients with SD or PD after auto-HSCT will refered to the allogeneic transplantatio program and take off the study.
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
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with relapsed or refracotry NHL or HD: PR or SD after first line salvage chemotherapy;
- •ECOG: 0-2
- •Tbil < 1.5x ULN and AST/ALT <2.5x ULN
- •With informed consent
排除标准
- •Life expectancy < 3 months
- •Women in pregnancy
- •uncontrollable infection disease
- •serum Cr >400mmol/l
- •uncontroled diabetis and heart disease
研究组 & 干预措施
Consolidation chemo
Patients recieved 3 cycles of consolidation chemotherapy post-auto-HSCT: mini-Bu-Cy-E regimen
干预措施: Bu-CY-E (Drug)
结局指标
主要结局
progression free survival
时间窗: 2-year
次要结局
- overall survival(2-year)
- progression(2-year)
- transplantation-related mortality(2-year)
研究者
Jiong HU
Head, Blood & Marrow Transplantation Center
Shanghai Jiao Tong University School of Medicine