NCT00568607Unknown2 期
Phase II Study of a Combination Chemotherapy of DICE in the Patients With NK/T Cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and tolerability of the combination chemotherapy of DICE in the patients with NK/T cell lymphoma.
详细描述
Patients with NK/T cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy of CHOP.The investigators did this trial to evaluate the efficacy and tolerability of the combination chemotherapy of DICE in the patients with NK/T cell lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range 18-75 years old
- •Histological confirmed NK/T cell lymphoma
- •ECOG performance status less than 2
- •Life expectancy of more than 3 months
- •None of major drugs in the trial (IFO,VP16,DDP) has been previously used
- •Normal laboratory values: hemoglobin > 80 g/dl, neutrophil > 2×109/L, platelet > 100×109/L, serum creatine < 1.5×upper limitation of normal (ULN), serum bilirubin < 1.5×ULN, ALT and AST < 2.5×ULN
排除标准
- •Pregnant or lactating women
- •Serious uncontrolled diseases and intercurrent infection
- •The evidence of CNS metastasis
- •History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
研究组 & 干预措施
IFO, VP-16, DDP, DXM
Experimental
干预措施: IFO, VP-16, DDP, DXM (Drug)
结局指标
主要结局
Response rate
时间窗: every two cycles
次要结局
- TTP and OS(every two cycles)
研究者
研究点 (1)
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