PD-1 Blockade With Pembrolizumab in Relapsed or Refractory Natural Killer/T Cell Lymphoma
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
- Response rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of PD-1 blockade pembrolizumab for patients with relapsed or refractory Natural Killer(NK)/T Cell Lymphoma.
详细描述
Patients with relapsed or refractory NK/T cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy. The investigators have been proceeding this trial to evaluate the efficacy and safety of the immune checkpoint inhibitor PD-1 blockade, pembrolizumab in the patients with relapsed or 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
- 14 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range 14-70 years old; ECOG performance status 0-2; Estimated survival time > 3 months
- •Histological confirmed evidence of relapsed or refractory NK/T cell lymphoma
- •Before enrollment, representative formalin-fixed paraffin-embedded tumor samples (or 15 tissue sections at least) and related pathological reports are needed
- •Previous treatment with at least one chemotherapy regimen
- •At least one measurable lesion
- •None of other serious diseases, cardiopulmonary function is normal
- •Pregnancy test of women at reproductive age must be negative
- •Patients could be followed up
- •None of other relative treatments including the traditional Chinese medicine, immunotherapy, biotherapy except anti-bone metastasis therapy and other symptomatic treatments.
- •volunteers who signed informed consent.
- •No anti-PD1 antibody contraindication (All of the following tests are required to be finished within 14 days prior to the first research): 2.5×109/L<WBC<15×109/L, hemoglobin ≥ 90 g/L, neutrophil≥ 1.5×109/L, lymphocyte≥0.5×109/L, platelet ≥ 100×109/L, serum albumin≥2.5g/dL, ALT and AST ≤ 2×ULN, serum bilirubin≤ 1.5×ULN, serum creatine ≤ 1.5×ULN, Serum Albumin ≥ 30g/L, serum plasminogen is normal, creatinine clearance rate≥30 mL/min, INR≤1.5×ULN, APTT≤1.5×ULN
排除标准
- •Disagreement on blood sample collection
- •Patients allergic of chimeric or humanized antibody
- •Pregnant or lactating women
- •Serious medical illness likely to interfere with participation
- •Serious infection
- •Primitive or secondary tumors of central nervous system
- •The evidence of CNS metastasis
- •History of peripheral nervous disorder or dysphrenia
- •History of active autoimmune disease and a concomitant second cancer
- •patients participating in other clinical trials
- •patients taking other antitumor drugs
- •patients estimated to be unsuitable by investigator
研究组 & 干预措施
PD-1 Blocking Antibody
Pembrolizumab
干预措施: Pembrolizumab (PD-1 Blocking Antibody) (Drug)
结局指标
主要结局
Response rate
时间窗: every 6 weeks, up to completion of treatment (approximately 18 weeks, unless the disease progresses or patients cannot tolerate the drug)
21 days (3 weeks) for one cycle, Efficacy was evaluated every two cycles.
次要结局
- Progression-free survival(up to end of follow-up-phase (approximately 24 months))
- Overall survival(up to the date of death (approximately 3 years))
- Median survival time(2 years)
研究者
Mingzhi Zhang
the director of oncology department of the first affiliated hospital
Zhengzhou University