NCT02753543Unknown2 期
A Multi-center, Prospective, Single-arm, Open Label Phase II Study of Chidamide Combined With Chemotherapy in the Treatment of Peripheral T Cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- complete response
研究概览
简要总结
This is a single arm, prospective trial to evaluate the efficacy and safety of Chidamide in combination with previous chemotherapy in peripheral T cell lymphoma patients who did not achieve complete response after 3 cycles of chemotherapy in interim evaluation.
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
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically verified peripheral T-cell lymphoma, partial response or stable disease after 3 cycles of CEOP (cyclophosphamide, epirubicin or doxorubicin, vincristine and prednisone) or CEOP(cyclophosphamide,vincristin,epirubicin and prednisone)/IVE (ifosfamide, epirubicin, etoposide)/GDP(Gemcitabine, Cis-platinum, Dexamethasone)
- •Age ≧16 years, ≦75 years
- •ECOG (Eastern Cooperative Oncology Group) =0,1,2
- •No previous history of malignancy
- •Radiologically measurable disease
- •Life expectancy>6 months
- •Informed consented
排除标准
- •Active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy
- •Lab at enrollment(unless caused by lymphoma)
- •Neutrophile<1.5*10^9/L
- •Platelet<75*10^9/L
- •Hemoglobulin<90g/L
- •ALT(alanine aminotransferase) or AST (aspartate aminotransferase ) >2*ULN,AKP(alkaline phosphatase) or bilirubin >1.5*ULN (upper limit of normal )
- •Creatinine>1.5*ULN
- •Other uncontrollable medical condition that may that may interfere the participation of the study
- •Not able to comply to the protocol for mental or other unknown reasons
- •Pregnant or lactation
- •HIV infection
研究组 & 干预措施
Chidamide plus previous chemotherapy
Experimental
Chidamide 20mg/d Biw p.o. on d1,4,8,11 for of each cycle for 3 cycles
干预措施: Chidamide (Drug)
结局指标
主要结局
complete response
时间窗: 21 days after 3 cycles of chidamide in combination with chemotherapy (each cycle is 21 days)
次要结局
- Progression free survival(1 year)
- Overall survival(1 year)
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0(Each cycle of treatment and then every 3 months for 1 year（each cycle is 21 days）)
研究者
研究点 (1)
Loading locations...
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