Combination of Basiliximab and Pegaspargase in the Treatment of Relapsed/Refractory Extranodal NK/T-cell Lymphoma, Nasal Type: a Single Arm, 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
- complete response rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Basiliximab in combination with pegaspargase in the treatment of relapsed/refractory NK/T-cell lymphoma.
详细描述
The investigators previously found that CD25 was elevated in patients who were resistant to chemotherapy, and CD25 can mediate resistance, which can be reversed by targeting CD25 therapy. Thus, the purpose of this study is to evaluate the efficacy and safety of Basiliximab in combination with pegaspargase in the treatment of relapsed/refractory NK/T-cell lymphoma.
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.
- •Previously treated with pegaspargase-based regimens.
- •PET-CT or MRI scan with at least one measurable lesion.
- •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 with a history of pancreatitis.
- •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
2500 IU/m2 pegaspargase given on day 1, 20 mg basiliximab given on day 1 and 8, repeated every 3 weeks
干预措施: Basiliximab (Drug)
treatment arm
2500 IU/m2 pegaspargase given on day 1, 20 mg basiliximab given on day 1 and 8, repeated every 3 weeks
干预措施: Pegaspargase (Drug)
结局指标
主要结局
complete response rate
时间窗: up to 15 weeks±1 week from start of treatment
evaluated by PET-CT scan or MRI, according to 2014 Lugano criteria for lymphoma
次要结局
- one year progression free survival rate(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)
- overall response rate(up to 15 weeks±1 week from start of treatment)
研究者
LIANG WANG
Professor of Department of Hematology
Beijing Tongren Hospital