NCT00854425已完成2 期
Phase II Study of L-asparaginase Monotherapy as Salvage Treatment in 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
- 状态
- 已完成
- 入组人数
- 40
- 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 L-asparaginase monotherapy as salvage treatment in patients with NK/T cell lymphoma
详细描述
The prognosis of patients with progressive and recurrent NK/T cell lymphoma is poor partially due to lack of effective treatment. L-asparaginase was reported to be effective in this setting by several case reports. The investigators aim to evaluate the efficacy and toxicity of L-asparaginase monotherapy in a prospective phase II study.
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 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 with progressive or recurrent disease
- •ECOG performance status 0-2
- •Life expectancy of more than 3 months
- •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
L-asp
Experimental
干预措施: L-asparaginase (Drug)
结局指标
主要结局
Response rate
时间窗: 6 weeks
次要结局
- Progression-free survival and overall survival(2 years)
研究者
研究点 (1)
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