Dose-adjusted EPOCH-R in Patients With Diffuse Large B-cell Lymphoma: a Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- 3-year progression-free survival
研究概览
简要总结
The aim of this study is to evaluate the efficacy and toxicity of dose-adjusted EPOCH-R in patients with MYC positive diffuse large B-cell lymphoma.
详细描述
The prognosis of MYC positive diffuse large B-cell lymphoma (DLBCL) is very poor even treated with R-CHOP regimen. Recently, dose-adjusted EPOCH-R was shown to be effective in patients with DLBCL and relapsed/refractory Burkitt lymphoma. The aim of this study is to evaluate the efficacy and toxicity of dose-adjusted EPOCH-R in patients with MYC positive diffuse large B-cell lymphoma.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated MYC positive diffuse large B-cell lymphoma
- •Age range 18-70 years old
- •Eastern Cooperative Oncology Group performance status 0-2
- •Life expectancy of more than 3 months
- •Adequate organ function
排除标准
- •Primary or secondary central nervous system involvement
- •Previous serious cardiac disease
- •History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- •Pregnant or lactating women
- •Serious uncontrolled diseases and intercurrent infection
研究组 & 干预措施
DA-EPOCH-R
rituximab 375mg/m2 IV day 0, etoposide 50mg/m2/d CIV days 1-4, doxorubicin 10mg/m2/d CIV days 1-4, vincristine 0.4mg/m2/d CIV days 1-4, cyclophosphamide 750mg/m2 IV day 5, prednisone 50mg PO days 1-5 twice per day
干预措施: DA-EPOCH-R (Drug)
结局指标
主要结局
3-year progression-free survival
时间窗: 3 years
次要结局
- 3-year overall survival(3 years)
- Objective response rate(4 months)
- Toxicity(6 months)