NCT01804127Unknown2 期
Interim PET/CT Guided Cycle Numbers of R-CHOP in Patients With Diffuse Large B-cell Lymphoma: a Exploratory Phase II Study Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 196
- 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 optimize the number of cycles of R-CHOP in patients with diffuse large B-cell lymphoma based on the interim results of PET/CT.
详细描述
R-CHOP is the standard regimen for patients with diffuse large B-cell lymphoma (DLBCL). However, the standard number of cycles is uncertain. Recently, interim PET/CT was found to predict prognosis in DLBCL. The hypothesis of this study is to optimize the number of cycles based on the interim results of PET/CT in order to avoid treatment exposure.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated diffuse large B-cell lymphoma
- •Age range 18-80 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
R-CHOP
Experimental
rituximab 375mg/m2 day 0, cyclophosphamide 750mg/m2 IV day 1, doxorubicin 50mg/m2 IV day 1, vincristine 1.4mg/m2 IV day1 (maximum: 2mg), prednisone 50mg PO days 1-5 twice per day
干预措施: R-CHOP (Drug)
结局指标
主要结局
3-year progression-free survival
时间窗: 3 years
次要结局
- Objective response rate(6 months)
- 3-year overall survival(3 years)
研究者
研究点 (1)
Loading locations...
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