Combination of Lenalidomide and Sintilimab for Patients With Relapsed/Refractory NK/T-cell Lymphoma Who Failed Pegaspargase-based Regimens: a Single Arm, Open, Phase II Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Rate of complete response
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 lenalidomide in the treatment of Relapsed/Refractory NK/T-cell lymphoma patients who failed pegaspargase-based regimens.
详细描述
Pegaspargase is the backbone of treatment for NK/T-cell lymphoma (ENKTCL), and patients with ENKTCL who failed pegaspargase-based regimens have extremely poor survival outcomes. Previous study has confirmed the efficacy of anti-PD-1 antibodies (including pembrolizumab or sintilimab). Constitutive activation of NF-kB pathway has been demonstrated to be involved in the development of ENKTCL and plays critical role in therapy resistance. Lenalidomide, an immuno-modulatory drug, has been found to inhibit NF-kB pathway, and synergize with anti-PD-1 antibody in the treatment of multiple myeloma. Thus, we hypothesize that the combination of lenalidomide and sintilimab will further deepen the remission status and benefit patients who failed pegaspargase-based regimens.
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
- •Histopathology and immunohistochemistry confirmed diagnosis of NK/T-cell lymphoma according to WHO 2016 criteria.
- •Previously treated with pegaspargase-based regimens (refractory or relapsed after initial remission).
- •PET/CT or CT/MRI with at least one objectively evaluable lesion.
- •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>50×10（9）/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 HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis 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.
- •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
treatment arm
Sintilimab, 200mg, iv day1 Lenalidomide, 25mg/d, oral, day 1-14 repeated every 3 weeks
干预措施: Sintilimab (Drug)
treatment arm
Sintilimab, 200mg, iv day1 Lenalidomide, 25mg/d, oral, day 1-14 repeated every 3 weeks
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Rate of complete response
时间窗: 24 weeks ±7 days
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
次要结局
- safety profiles(up to 1year after enrollment)
- Rate of overall response(24 weeks ±7 days)
- 1-year progression free survival rate(up to 1year after enrollment)
- 1-year overall survival rate(up to 1year after enrollment)
研究者
JING-WEN WANG
Professor of Department of Hematology
Beijing Tongren Hospital