Phase II Study of IGEV Followed by Autologous Stem Cell Transplantation in Patients With Refractory or Relapsed Hodgkin Lymphoma.
试验速览
- 阶段
- 2 期
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Complete response rate
研究概览
简要总结
The aim of study is to prove IGEV regimen followed by autologous stem cell transplantation as salvage treatment in patients with refractory or relapsed Hodgkin lymphoma is effective.
详细描述
The standard treatment in patients with refractory or relapsed Hodgkin lymphoma is salvage chemotherapy followed by autologous transplantation for responsive patients. However, the standard of salvage chemotherapy remains uncertain. This study is to evaluate the efficacy and safety of IGEV regimen in a single-center basis.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: 18-65 years old
- •Histological confirmed refractory or relapsed Hodgkin lymphoma
- •With at least one site of measurable disease according to IWC criteria
- •ECOG performance status 0-1
- •Life expectancy of more than 3 months
- •Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧80g/L
- •Liver function: total bilirubin, ALT and AST <1.5×UNL
- •Renal function: Cr<1.5×UNL, CCR≧45ml/min
- •No contraindication for transplantation
排除标准
- •No prior chemotherapy
- •With more than 2 lines of prior chemotherapy exposure
- •Evidence of CNS and bone marrow involvement
- •History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- •Pregnant or lactating women
- •Significant active infection
研究组 & 干预措施
IGEV regimen
Ifosfamide 1200 mg/m2 at days 1-4, Mesna 400 mg 0,4,8h at days 1-4, Gemcitabine 800 mg/m2 at day 1 and day 4, Vinorelbine 20 mg/m2 at day 1, Prednisone 100 mg at days 1-4. Frequency of cycles: every 3 weeks. Numbers of cycles: 4 cycles
干预措施: IGEV (Drug)
结局指标
主要结局
Complete response rate
时间窗: 6 weeks
次要结局
- 3-year progression-free survival rate(3 years)
- Overall response rate(6 weeks)
- 3-year overall survival rate(3 years)