Single-arm, Multi-center Clinical Study of PD-1 Antibody, Chidamide, Lenalidomide and Etoposide for Relapsed or Refractory Natural Killer/T Cell Lymphoma
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Overall Response Rate
研究概览
简要总结
To observe the safety, tolerability and clinical effects of PD-1 Antibody, Chidamide, Lenalidomide and Etoposide in Relapsed or Refractory NK/T cell Lymphoma.
详细描述
This is a prospective, open-label, one-arm, multicenter clinical trial, aimed to evaluate the safety, tolerability, and efficacy of PD-1 Antibody, Chidamide, Lenalidomide and Etoposide in Relapsed or Refractory NK/T cell Lymphoma. A total of 50 patients are planned to be enrolled into the study. The primary end points are objective responder rate (ORR) and progression free survival(PFS) and the secondary end points include overall survival(OS) , and adverse events.
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 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age:14-65 years;Eastern Cooperative Oncology Group (ECOG)score≤2;expected survival≥3 months;
- •patients with NK/T Cell Lymphoma diagnosed by immuno-histochemistry (IHC) or fluorescence in situ hybridization (FISH);
- •Refractory or relapse after at least 2 regimen;
- •Once the patient received radiotherapy, need to be more than 3 months away from this treatment, and it is a non-primary recurrence;
- •No chemotherapy contraindications: hemoglobin ≥ 100g / L, absolute neutrophil count ≥ 1.5 × 109 / L, platelets ≥ 80 × 109 / L, ALT, AST ≤ 2 times the upper limit of normal, serum total bilirubin ≤ 1.5 times normal Upper limit, serum creatinine ≥ 1.5 times normal upper limit, serum protein ≥ 30g / L;
- •At least one measurable lesion;
- •There are no other serious diseases that conflict with this program, and the cardiopulmonary function is normal;
- •Women of childbearing age must have a negative urine or blood pregnancy test, and male patients should be contraceptive during medication;
- •There is no other antitumor treatment, but bisphosphonate for anti-bone metastasis treatment and other symptomatic treatment can be applied;
- •Can understand the situation of this study and sign the informed consent voluntarily
排除标准
- •rejecting providing blood preparation;
- •allergic to drug in this study or with hemophagocytic syndrome;
- •rejecting adopting reliable contraceptive method in pregnancy or lactation period;
- •uncontrolled internal medicine disease(including uncontrolled diabetes,severe incompetence cardiac,lung,liver and pancreas）；
- •with severe infection;
- •with primary or secondary central nervous system tumor invasion;
- •with Chemotherapy or radiotherapy contraindication;
- •ever suffered with malignant tumor;
- •Human immunodeficiency virus (HIV)-positive patients
- •Drug abuse or long-term alcohol abuse that affects the evaluation of test results;
- •Have peripheral nervous system disorder or mental disorder;
- •Patients with immune system diseases;
- •Those who have no legal capacity or whose research is affected by medical or ethical reasons;
研究组 & 干预措施
PD-1 Antibody, chidamide, lenalidomide and etoposide
PD-1 Antibody: 240mg, d1, Chidamide: 20mg, twice a week, Lenalidomide: 25mg, d1-14 Etoposide:100mg/m2, d1-3 and 21 days made one treatment cycle.
干预措施: PD-1 Antibody, chidamide, lenalidomide and etoposide (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: From date of randomization until the date of first date tumor volume has reduced, assessed up to 36 months
The proportion of patients whose tumor volume has reduced to a predetermined value and can maintain the minimum time limit is the sum of complete and partial mitigation.
次要结局
- Overall Survival(From date of randomization until date of death from any cause, assessed up to 36 months)
- Progression-free Survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months)
研究者
Mingzhi Zhang
the director of oncology department of the first affiliated hospital
Zhengzhou University