Maintenance Therapy With Anti-PD-1 Antibody for Patients With NK/T-cell Lymphoma: a Single Arm, Single Center, Open Label, Phase 2 Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 主要终点
- one-year progression free survival rate
研究概览
简要总结
For patients with NK/T-cell lymphoma, plasma EBV-DNA has been found to be a prognostic factor, and those with positive plasma EBV-DNA at the end of treatments are more likely to suffer from disease relapse. Thus, this study aims to evaluate the role of maintenance with anti-PD-1 antibody.
详细描述
For patients with NK/T-cell lymphoma, plasma EBV-DNA has been found to be a prognostic factor, and those with positive plasma EBV-DNA at the end of treatments are more likely to suffer from disease relapse. The investigators previously reported one-year progression free survival rate of 22.2% for patients with positive plasma EBV-DNA at the end of treatments. Recently, anti-PD-1 antibody has been shown to be highly effective in the treatment of NK/T-cell lymphoma. Thus, this study aims to evaluate the role of maintenance with anti-PD-1 antibody for patients with positive plasma EBV-DNA at the end of treatments.
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
- •Pathology confirmed diagnosis of NK/T-cell lymphoma.
- •Plasma EBV-DNA was positive at the end of first-line pegaspargase-based regimens.
- •ECOG score of 0-3 points.
- •The lab tests within 1 week before enrollment meets the following:
- •Blood routine: Hb≥80g/L, PLT≥50×10e9/L.
- •Liver function: ALT, AST, TBIL≤2 times the upper limit of normal.
- •Renal function: Cr is normal.
- •Coagulation: plasma fibrinogen≥1.0g/L.
- •Cardiac function: LVEF≥50%, ECG is normal
- •Sign the informed consent form.
- •Voluntary compliance with research protocols.
排除标准
- •Patients had relapsed NK/T-cell lymphoma.
- •Active infection requires ICU treatment.
- •Concomitant HIV infection or active infection with HBV, HCV.
- •Serious complications such as fulminant DIC.
- •Significant organ dysfunction:
- •respiratory failure
- •NYHA classification≥2 chronic congestive heart failure
- •decompensation Hepatic or renal insufficiency
- •high blood pressure and diabetes that cannot be controlled
- •cerebral vascular events within the past 6 months.
- •Pregnant and lactating women.
- •Had a history of autoimmune diseases, and disease was active now. Those who were known to be allergic to drugs in the study regimen.
- •Patients with other tumors who require treatments within 6 months.
- •Other experimental drugs are being used.
研究组 & 干预措施
treatment arm
anti-PD-1 antibody (toripalimab) 240mg/d, every 3 weeks, for up to one year or until disease progression.
干预措施: toripalimab (Drug)
结局指标
主要结局
one-year progression free survival rate
时间窗: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
progression free survival is caculated from date of study enrollment to documented disease progression or death of any reason, whichever came first
次要结局
- negative conversion rate of plasma EBV-DNA(up to one year)
- one-year overall survival rate(From date of enrollment until the date of documented death from any cause or last follow up, whichever came first, assessed up to 12 months)
研究者
LIANG WANG
Director of department of hematology
Beijing Tongren Hospital