A Multi-center, Prospective Study of the Efficacy and Safety of PD-1 Antibody (Sintilimab) in Combination With Pegaspargase and Erlotinib in the Treatment of Stage IV Extranodal NK/T-cell Lymphoma Unfit for High-intensity Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 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 safety of Sintilimab in combination with Pegaspargase and anlotinib in the treatment of stage IV NK/T-cell lymphoma patients unfit for high-dose chemotherapy.
详细描述
Stage IV NK/T-cell lymphoma has a poor prognosis, and autologous hematopoietic stem cell transplantation can improve the prognosis of patients who have achieved remission after chemotherapy. The median survival time for patients who were not suitable for transplantation was about 1 year. Asparaginase is the backbone drug for the treatment of NK/T-cell lymphoma. PD-1 antibody is effective for relapsed/refractory NK/T-cell lymphoma. Our previous study found that anlotinib is active in relapsed/refractory NK/T Cell lymphoma. This study is aimed to investigate the efficacy and safety of Sintilimab, a PD-1 antibody approved in China, in combination with Pegaspargase and anlotinib in the treatment of stage IV NK/T-cell lymphoma patients unfit for high-dose chemotherapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathology and immunohistochemistry confirmed diagnosis of NK/T-cell lymphoma according to WHO 2016 criteria.
- •Stage IV disease according Lugano 2014 staging system. Newly diagnosed patients, or relapsed disease without a history of asparaginase-containing regimen.
- •PET/CT or CT/MRI with at least one objectively evaluable lesion.
- •The age is greater than 65 years old. Those who are younger than 65 years should have a documented history unfit for high-dose combination chemotherapy (ie. high doses of methotrexate or high doses of dexamethasone, or autologous hematopoietic stem cell transplantation).
- •General status ECOG score 0-3 points.
- •The laboratory test within 1 week before enrollment meets the following conditions:
- •Blood routine: Hb>80g/L, PLT>50×109/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 does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking.
- •Sign the informed consent form.
- •Voluntary compliance with research protocols, follow-up plans, laboratory and auxiliary examinations.
排除标准
- •Patients with a history of pancreatitis.
- •Active infection requires ICU treatment.
- •Concomitant HCV or HIV infection. Patients who are infected with HBV at the same time are not excluded.
- •Serious complications such as fulminant DIC.
- •Significant organ dysfunction: such as respiratory failure, NYHA classification ≥ 2 chronic congestive heart failure, decompensation Hepatic or renal insufficiency, high blood pressure and diabetes that cannot be controlled despite active treatment, and cerebral vascular thrombosis or hemorrhagic time within the past 6 months.
- •Pregnant and lactating women.
- •Had a history of autoimmune diseases, and disease was active in the last 6 months, and was still taking oral immunosuppression in the past three months.
- •For the treatment, the daily dose of oral prednisone is greater than 10 mg.
- •Those who were known to be allergic to drugs in the study regimen.
- •Patients with other tumors who require surgery or chemotherapy within 6 months.
- •Other experimental drugs are being used.
研究组 & 干预措施
LEAP Regimen
Pegaspargase, 2500IU/m2, im, day 1 Sintilimab, 200mg, iv day1 Anlotinib, 8mg, oral, day 1-14 The LEAP regimen will be repeated every 3 weeks.
干预措施: LEAP regimen (Drug)
结局指标
主要结局
Complete response rate
时间窗: Week 24 +/-7 days
The complete response rate will be assessed on week 24.
次要结局
- Progression free survival(1-year)
- Treatment-Related Adverse Events as Assessed by CTCAE v4.0(Day 1 of each course of chemotherapy and then every 3 months for 1 year)
- Overall survival(1-year)
- Overall response rate(Week 24 +/-7 days)
研究者
Rong Tao
Associate director of department of hematology
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine