A Clinical Trial of Chidamide Combined With Etoposide in Relapsed or Refractory NK/T-cell Lymphoma
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
To observe the safety, tolerability and clinical effects of Chidamide Combined With Etoposide in Relapsed or Refractory NK/T-cell Lymphoma.
详细描述
This is a prospective, open-label, one-arm, single center clinical trial, aimed to evaluate the safety, tolerability, and efficacy of Chidamide Combined With Etoposide in Relapsed or Refractory NK/T-cell Lymphoma. A total of 30 patients are planned to be enrolled into the study. Patients with diagnosis of Relapsed or Refractory NK/T-cell Lymphoma will be treated with Chidamide plus Etoposide capsules. The primary end points are objective responder rate (ORR) and a time to response(TTR) and response duration (DOR) and progression free survival(PFS) 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
- 10 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.age:10-65 years;Eastern Cooperative Oncology Group (ECOG)score≤2;expected survival≥3 months 2 patients with NK/T Cell Lymphoma diagnosed by immuno-histochemistry (IHC) or fluorescence in situ hybridization (FISH); 3.Refractory or relapse after at least 2 regimen 4.Once the patient received radiotherapy, need to be more than 3 months away from this treatment, and it is a non-primary recurrence; 5.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; 6.At least one measurable lesion 7.There are no other serious diseases that conflict with this program, and the cardiopulmonary function is normal; 8.Women of childbearing age must have a negative urine or blood pregnancy test, and male patients should be contraceptive during medication; 9.There is no other antitumor treatment, but bisphosphonate for anti-bone metastasis treatment and other symptomatic treatment can be applied.
- •10.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 Chemotherap 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;
- •Those who have no legal capacity or whose research is affected by medical or ethical reasons;
研究组 & 干预措施
Chidamide+ Etoposide capsule
Chidamide: 30mg, twice a week(BIW), PO.
Etoposide capsule:50mg, quaque die （QD）, PO, d1-10，21days for one cycle. Patients receive the other treatment of chidamide and etoposide capsule, and those who have achieved PD(progressive disease) will give the other treatment.
干预措施: Chidamide+ Etoposide (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: up to 24 months
次要结局
- Time To Response (TTR)(Up to 3 months)
- Duration of Response (DOR)(Up to 2 years)
- Progression Free Survival (PFS) Progression Free Survival(up to 24 months)
研究者
Mingzhi Zhang
The director of oncology department of the first affiliated hospital
Zhengzhou University