A Prospective, Multi-center Study of Whole-course Management of Pegaspargase in Extranodal NK/T Cell Lymphoma (ENKTL)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Plasma activity curve of pegaspargase
研究概览
简要总结
This is a prospective, multi-center study of the whole-course management of pegaspargase in Extranodal NK/T cell lymphoma (ENKTL). Based on a complete population pharmacokinetic model of pegaspargase in ENKTL patients, the time node of asparaginase monitoring and the principle of dose adjustment will be formulated. Besides, the proportion of "silent inactivation" of asparaginase in ENKTL patients and its effect on the prognosis of patients will also be explored. The treatment plan is as follows: (1) During 8 early (stage I/II) ENKTL patients receiving P-GOD (peasparaginase + gemcitabine + oxaliplatin + dexamethasone) for the first time, the activity of pegaspargase in peripheral blood will be detected on D3, D4, D5, D6, D7, D8, D10, D12, D14, D16, D18 and D21. (2) During 4 early (stage III/IV) ENKTL patients receiving PEMD (peaspargase + etocytidine + methotrexate + dexamethasone) for the first time, the activity of pegaspargase in peripheral blood will be detected on D3, D4, D5, D6, D7, D8, D10, D12, D14, D16, D18 and D21. (3) During 72 (including above 12 patients) ENKTL patients receiving P-GOD/PEMD, the activity of pegaspargase and anti-pegaspargase in peripheral blood will be detected on D9 and D16 of each cycle of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed first-line ENKTL patients according to WHO 2016
- •Willingness to provide written informed consent.
排除标准
- •Patients are unsuitable for the enrollment according to investigator's judgement.
研究组 & 干预措施
P-GOD
P-GOD (peasparaginase + gemcitabine + oxaliplatin + dexamethasone) ;
干预措施: Pegaspargase（P-GOD） (Drug)
PEMD
PEMD (peaspargase + etocytidine + methotrexate + dexamethasone)
干预措施: Pegaspargase（PEMD） (Drug)
结局指标
主要结局
Plasma activity curve of pegaspargase
时间窗: Plasma activity measurement of pegaspargase [time frame: Day3, Day4, Day5, Day6, Day7, Day8, Day10, Day12, Day14, Day16, Day18, and Day21 of first use of pegaspargase]
pegaspargase in ENKTL patients
次要结局
- the proportion of "silent inactivation"(days 7, 14, 21 of treatment)