A Multi-center Phase II Study of R-ESHAP Followed by Autologous Transplantation as Salvage Treatment for Patients With Refractory or Relapsed Diffuse Large B-cell Lymphoma.
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
The aim of study is to prove R-ESHAP regimen followed by autologous stem cell transplantation as salvage treatment in patients with refractory or relapsed diffuse large B-cell lymphoma is effective.
详细描述
The standard treatment in patients with refractory or relapsed diffuse large B-cell 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 R-ESHAP regimen in a multi-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 diffuse large B-cell lymphoma
- •Refractory or first relapsed disease
- •Prior anthracycline exposure
- •Measurable disease
- •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≧90g/L
- •Liver function: total bilirubin, ALT and AST <1.5×UNL
- •Renal function: Cr<1.5×UNL, CCR≧50ml/min
- •No contraindication for transplantation
排除标准
- •Evidence of CNS and bone marrow involvement
- •More than 1 type of chemotherapy regimens exposure
- •High level of HBV DNA
- •Contraindication of high-dose methylprednisolone
- •Pregnant or lactating women
- •History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- •History of allergic reaction/hypersensitivity to rituximab
- •Significant active infection
研究组 & 干预措施
R-ESHAP
Rituximab 375mg/m2 at day 0, Meththylprednisolone 500mg IV at days 1 to 5, Etoposide 40mg/m2 at days 1 to 4, Cisplatin 25mg/m2 at days 1 to 4, Cytarabine 2000mg/m2 at day 5. Frequence of cycles: every 3 weeks. Numbers of cycles: 3 cycles.
干预措施: R-ESHAP (Drug)
结局指标
主要结局
Overall response rate
时间窗: 6 weeks
次要结局
- 3-year progression-free survival rate(3 years)
- 3-y overall survival rate(3 years)