A Phase II Study of Avelumab in Relapsed or Refractory Extranodal Natural Killer/T-cell Lymphoma
试验速览
- 阶段
- 2 期
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- The rate of response of avelumab.
研究概览
简要总结
This study was conducted to evaluate the complete response rate of avelumab in patients with NK / T-cell lymphoma besides relapsed or refractory stage lymphoma.
详细描述
Extranodal natural killer/T-cell lymphoma (ENKTL) generally has poorer prognosis than other lymphomas because the majority of patients are present as advanced disease and show poor response to treatment.
In particular, treatment of relapsed or refractory stage ENKTL is very poor and there is no standard treatment.
ENKTL is entirely infected with Epstein-Barr virus (EBV) and the prevalence of this disease is closely related to EBV.
Therefore, the biological properties of ENKTL may be affected by EBV-related protein and LMP1 may induce activation of molecules in various sub-channels, such as PI3K/Akt and NF-kB, and affect the aggressiveness of lymphoma.
As an increase in PDL1 has been reported recently among the major roles of LMP1, the role of Immuno-oncology drug targeting PDL1 among ENKTL is expected.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
avelumab
-
1 Cycle: 10mg/kg Avelumab administered via IV every 2 weeks (1st, 15th)
-
Interval of 1 cycle: 28 days ③ Administration schedule: Repeated until disease progression or unacceptable toxicity and dose adjustments may be permitted based on the toxicity that occurs every cycle.
干预措施: avelumab (Drug)
结局指标
主要结局
The rate of response of avelumab.
时间窗: From date of enrollment until the date first documented disease progression or unacceptable toxicity, whichever came first, assessed up to 48 months
To assess the efficacy of disease control including complete response (CR), partial response (PR) and stable disease (SD)
次要结局
- Progression-free survival(the time between the date of treatment start and the date of death due to any cause or date of disease progression..assessed up to 48 months)
- Toxicity Profile(from the date of informed consent signature to 30 days after last drug administration.)
- Overall survival (OS)(Time between the start of treatment and the date of death.assessed up to 48 months)
研究者
Won Seog Kim
Clinical Professor
Samsung Medical Center