NCT03268889Unknown不适用
Chidamide With Cyclophosphamide, Etoposide, Vincristine and Prednisone for de Novo Peripheral T Cell Lymphoma Patients
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2017年6月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Complete Remission Rate
研究概览
简要总结
This study evaluates the efficacy and safety of Chidamide plus CHOP regimen for de novo PTCL patients.
详细描述
After enrollment, patients in this study will be given Chidamide, Cyclophosphamide, Epirubicin, Vincristine and Prednisone, and the efficacy and safety of this regimen are then evaluated.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically diagnosed as peripheral T cell lymphoma (PTCL) according to WHO 2008 classification criteria（NK/T cell lymphoma, ALK positive anaplastic large cell lymphoma and granuloma fungoides excluded）;
- •De novo peripheral T cell lymphoma patients;
- •Age 18-70 years old;
- •Female patients not in lactation nor pregnancy, and no intention to concept during the study and 12 months thereafter. Male patients agree not to impregnate his partner during the study and 12 months thereafter;
- •The patient should have evaluable foci (lymphnodes with diameter≥1.0cm, or evaluable skin foci);
- •Willing to sign a written consent.
排除标准
- •T lymphoblast lymphoma;
- •Bone marrow infiltrated with lymphoma cell ≥25%；
- •NT/T cell lymphoma;
- •Granuloma fungoides;
- •Severe impaired liver/ renal function (ALT, Bilirubin or creatinine >3 times the normal maximum);
- •Uncontrolled infection;
- •Organic cardiopathy with clinical manifestation or impaired cardiac function (NYHA ≥ level 2);
- •With other tumors;
- •With other condition that cause the patient unable to sign the written consent;
研究组 & 干预措施
treatment group
Experimental
In this arm, patients would be given the regimen composed of Chidamide, Cyclophosphamide, epirubicin, Vincristine and Prednisone.
干预措施: Chidamide (Drug)
结局指标
主要结局
Complete Remission Rate
时间窗: every 3 months until 30 months after the last patient's enrollment
the rate of patients who achieve complete remission after the treatment
次要结局
- duration of remission(from the day of treatment to the date of first documented progression，up to 30 months after the last patient's enrollment)
- progression free survival(from the day of treatment to the date of first documented progression，up to 30 months after the last patient's enrollment)
- overall survival(30 months after the last patient's enrollment)
- adverse events(from the date of first cycle of treatment to 30 months after last patient's enrollment)
研究者
研究点 (1)
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