Chidamide Combined With Cyclophosphamide, Prednisone, Thalidomide in Treatment of Fragile Patients With Relapse/Refratory Peripheral T Cell Lymphoma :a Phase II, Single-arm, Open-label, Muti-center Study
试验速览
- 阶段
- 2 期
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
The purpose of this study is to investigate efficacy and safety of Chidamide Combined With Cyclophosphamide,Prednisone,Thalidomide in Treatment of Fragile Patients With Relapse/Refratory Peripheral T Cell Lymphoma :a Phase II,Single-arm,Open-label, Muti-center Study
详细描述
Chidamide is a new histone deacetylase inhibitor and shows anti-tumor activity in Relapse/Refratory Peripheral T Cell Lymphoma.Cyclophosphamide,Prednisone,Thalidomide(CPT) is an oral combination regimen for lymphoma patients who can not stand the standard chemotherapy. The investigators therefore design this open-label,phase II, single-arm trial to investigate the efficacy of Chidamide Combined With CPT in treatment of fragile Patients With Relapse/Refratory Peripheral T Cell Lymphoma
Primary Outcome Measures:
• overall response rate
Secondary Outcome Measures:
- duration of response
- progression free survival
- overall survival Enrollment:45 Study Start Date: August 2016 Primary Completion Date: March 2018
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
- •Histologically confirmed Peripheral T Cell Lymphoma,exclude NK/T cell lymphoma
- •Relapse or refractory to at least one prior therapy(chemotherapy or stem cell transplantation)
- •age between 18 and 75, both gender
- •ECOG PS 0-1
- •Peripheral ANC >1.5*109/L; platelet >70*109/L; Hb≥ 90g/L
- •Anticipated survival ≥ 3 months
- •No chemotherapy ,radiotherapy and stem cell transplantation within 4 weeks before inclusion
- •Sign in informed consent form, adherence to the study visit schedule and other protocol requirements
排除标准
- •Pregnant women or women in suckling period or with Potentia Generand but not willing to take contraceptives
- •New York Heart Association class III or IV cardiac failure; or history of following disease in past 6 months: acute coronary syndrome, acute heart failure, severe ventricular arrhythmia
- •Poor hepatic function, defined as total bilirubin more than 1.5 fold of upper normal level, ALT, AST more than 2 fold of upper normal level or more than 5fold of upper normal level with hepatic involvement;Poor renal function, defined as serum creatinine more than 1.5 fold of upper normal level
- •CNS or meningeal involvement
- •intervention on myelosuppression within7 days before inclusion
- •patients with active bleeding
- •Major surgery within three weeks before inclusion
- •Positive HIV, syphilis,HCV, or HBV virus load(HBV DNA)> 1×105 copies/ml;
- •Any psychological conditions which may disturb consent.
- •In any conditions which investigator considered ineligible
- •Known sensitivity or allergy to investigational Product.
研究组 & 干预措施
C-CPT
干预措施: C-CPT (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: One-year
overall response rate after treated by C-CPT
次要结局
- Duration of response(One-year)
- Progress-free survival(One-year)
- Overall survival(One-year)
研究者
WEI XU
Professor
The First Affiliated Hospital with Nanjing Medical University