NCT00933673Unknown2 期
Phase II Study of L-asparaginase Plus DICE Regimen in Patients With Stage I/II 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
- 76
- 试验地点
- 1
- 主要终点
- complete 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 L-asparaginase plus DICE regimen in the patients with early stage NK/T-cell lymphoma.
详细描述
DICE regimen was found to be highly effective as induction chemotherapy in patients with early stage NK/T-cell lymphoma in the ongoing study. L-asparaginase, an agent with unique anti-cancer mechanism, was also found to be effective in salvage setting. In terms of non-overlapped efficacy and toxicity, the investigators designed this phase II study to verify the efficacy and tolerability of this new combination.
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
- 14 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range 14-75 years old
- •Histological confirmed, previously untreated stage I/II NK/T cell lymphoma in the upper-aerodigestive tract
- •ECOG performance status less than 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-DICE
Experimental
干预措施: L-asp, DXM, IFO, VP-16, DDP (Drug)
结局指标
主要结局
complete response rate
时间窗: 6 weeks
次要结局
- Overall response rate, PFS and OS(6 weeks)
研究者
研究点 (1)
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