Efficacy and Safety of Tislelizumab Combined Treatment in Refractory Natural Killer/T-cell Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
Natural killer/T-cell lymphoma (NKTCL) patients with relapsed/refractory disease had very poor outcome. Anti-PD-1 antibody showed promising results in response, but but the complete remission rate of was low. Some anti-PD-1 antibody based regimen showed higher and deeper response in NKTCL patients.
详细描述
About 20-30% of early-stage patients and 40-60% of late-stage NKTCL patients will experience disease relapse and refractory disease, and the median survival time of relapsed patients is about 6 months. PD-1 antibody is an effective drug for the treatment of patients with relapsed/refractory NKTCL, but the response rate and complete remission rate of monotherapy are low. How to improve the prognosis of patients is an important way to try combination therapy. In this study, we aim to explore the effectiveness and safety of a novel anti-PD-1 antibody, tislelizumab, in combination with different drugs (tislelizumab plus azacytidine and lenalidomide, or tislelizumab plus etoposide and pegaspargase) to treat refractory NK/T.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with biopsy histopathology, immunohistochemistry and EBER test meet ing the WHO 2016 diagnostic criteria for NK/T cell lymphoma.
- •With progressive disease after asparaginase-based combined chemotherapy
- •Have experienced multiple courses of PD-1/PD-L1 treatment with non-responsive or progressive disease.
- •PET/CT or CT/MRI with at least one measurable lesion or objectively evaluable lesion.
- •General ECOG score 0-3 points.
- •The laboratory examination 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. Blood coagulation test: plasma fibrinogen ≥1.0g/L. Heart function: LVEF≥50%, ECG did not indicate any acute myocardial infarction, arrhythmia, or atrioventricular block of degree I or more.
- •Signed informed consent form.
- •Voluntarily comply with research protocols, follow-up plans, laboratory and auxiliary examinations.
排除标准
- •Patients with a history of pancreatitis (only patients who are planning to undergo PD1 combined with pegaspargase are excluded).
- •Severe infections require ICU treatment.
- •Combined HCV or HIV infection. Patients with HBV infection who receive antiviral treatment at the same time will not be excluded.
- •There are serious complications such as fulminant DIC.
- •Impairment of important organ functions: such as respiratory failure, chronic congestive heart failure with NYHA grade ≥2, decompensated liver or kidney insufficiency, hypertension and diabetes that cannot be controlled despite active treatment, nearly 6 years old There were cardio-cerebrovascular thrombotic or hemorrhagic events within months.
- •Pregnant and lactating women.
- •Have a history of autoimmune diseases, have disease activity in the past 6 months, and are still receiving oral immunosuppressive therapy within the past three months, and the daily dose of oral prednisone is greater than 10 mg.
研究组 & 干预措施
TALE regimen
tislelizumab plus azacytidine and lenalidomide
干预措施: tislelizumab, azacytidine, lenalidomide (Drug)
TEPA regimen
tislelizumab plus etoposide and pegaspargase
干预措施: tislelizumab, etoposide, pegaspargase (Drug)
结局指标
主要结局
Overall response rate
时间窗: Week 12 +/-7 days
The overall response rate will be assessed on Week 12
次要结局
- Complete response rate(Week 12 +/-7 days)
- Overall survival(1-year)
- Progression free survival(1-year)
- Treatment-Related Adverse Events as Assessed by CTCAE v5.0(Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v5.0.)
研究者
Rong Tao
MD
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine