NCT03598959Unknown2 期
Phase I/II Study of Safety and Efficacy of Tofacitinib Combined With Chidamide in Patients With Relapsed and Refractory Extranodal Natural Killer/T Cell Lymphoma
Sichuan University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年1月1日最近更新:
适应症
干预措施
相关药物
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
- 2-year progression free survival
研究概览
简要总结
This study is to explore the efficacy and safety of tofacitinib combined with chidamide in patients with relapsed and refractory extranodal 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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary refractory or recurrent extranodal NK/T cell lymphoma that do not qualify for treatment protocols of higher priority.
- •Adequate renal function, as defined by estimated serum creatinine clearance >/=50 ml/min and/or serum creatinine </= 1.8 mg/dL.
- •Adequate hepatic function, as defined by serum glutamate oxaloacetate transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) </= 3 x upper limit of normal; serum bilirubin and alkaline phosphatase </= 2 x upper limit of normal.
- •4.. Adequate cardiac function with left ventricular ejection fraction >/= 50%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- •Performance status 0-
- •Negative Beta diffusing capacity of lung for carbon monoxide (HCG) text in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization
排除标准
- •Patients relapsed after allogeneic stem cell transplant
- •Patients with active hepatitis B or C(HBV DNA >/=10,000 copies/mL).
- •Active infection requiring parenteral antibiotics
- •HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal cluster of differentiation 4 (CD4) counts
- •Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.
- •Patients with a cQT longer than 500 ms
研究组 & 干预措施
Treatment
Experimental
Treated with tofacitinib and chidamide for 4 cycles.
干预措施: tofacitinib (Drug)
Treatment
Experimental
Treated with tofacitinib and chidamide for 4 cycles.
干预措施: chidamide (Drug)
结局指标
主要结局
2-year progression free survival
时间窗: 2 years after recruitment
次要结局
- adverse events (AEs)(2 years after recruitment)
- complete remission(4 months after treatment)
- 2-year overall survival(2 years after recruitment)
研究者
Jie Ji
Clinical Professor
Sichuan University
研究点 (1)
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