Chidamide Combination With Lenalidomide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma: an Open Label, Single Arm, Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
The purpose of this open label,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Chidamide combination with lenalidomide for relapsed or refractory peripheral T-cell lymphoma.
详细描述
Histone deacetylase(HDAC) inhibitor has been used in relapsed or refractory peripheral T-cell lymphoma.There are no international studies of Chidamide combination with lenalidomide for relapsed or refractory peripheral T-cell lymphoma. Therefore, this study intends to select the oral HDAC inhibitor Chidamide combined with lenalidomide for relapsed or refractory peripheral T-cell lymphoma, and explore its efficacy and safety.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •peripheral T cell lymphoma (PTCL);
- •no remission or relapse after at least one previous systemic treatment；
- •at least one assessable lesion；
- •18-75 years;
- •ECOG PS 0-2;
- •proper functioning of the major organs;
- •expected survival time ≥3 months.
排除标准
- •previous received treatment of HDAC inhibitor or lenalidomide;
- •central nervous system (CNS) involvement;
- •serious heart problems;
- •known allergies to experimental drug ingredients;
- •diagnosed with or receiving treatment for a malignancy other than lymphoma;
- •uncontrolled active infection, with the exception of tumor-related b-symptom fever;
- •unable or unwilling to receive antithrombotic therapy;
- •history of deep vein thrombosis (DVT) or pulmonary embolism (PE) in the past 12 months;
研究组 & 干预措施
Chidamide combined Lenalidomide
Chidamide, 20 mg, twice per week; lenalidomide, 25 mg, d1-21, and rest for 7 days.
one treatment cycle per 28 days.For patients with limited lesions and good drug response, local radiotherapy may be assessed by the investigator.
干预措施: Chidamide, Lenalidomide (Drug)
结局指标
主要结局
ORR
时间窗: 4-years
Overall Response Rate
次要结局
- DOR(4-years)
- OS(4-years)
- PFS(4-years)
研究者
Qingqing Cai
Chief physician
Sun Yat-sen University