Azacytidine Combined With Chidamide in the Treatment of Relapsed and Refractory Angioimmunoblastic T-cell Lymphoma: a Multicenter Single Arm Phase II Study
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
This is a multicenter prospective single arm phase II study. The purpose of this study is to evaluate the safety and efficiency of azacytidine combined with chidamide in the treatment of relapsed/refractory angioimmunoblastic T-cell lymphoma.
详细描述
Azacytidine was given subcutaneously at a dose of 75 mg/m2 on days 1-7. Chidamide was an oral tablet which was administered 20mg twice weekly. This regimen was repeated every 28 days. Treatment was given until disease progression, unacceptable toxicity, or patient/investigator discretion.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed angioimmunoblastic T-cell lymphoma according World Health Organization (WHO) classification;
- •Age≥18years;
- •Patients received at least one systemic treatment previously and achieved no remission or relapsed after first-line treatment;
- •Adequate bone marrow hematopoietic function: ANC>1.5 × 109/L，HGB>90g/L，PLT>80 × 109/L;
- •Adequate organ function: ALT≤3 times ULN, TBil≤1.5 times ULN, SCr≥50ml/min/m2, cardiac function grade 0-2 (NYHA);
排除标准
- •Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment;
- •Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy;
- •Pregnant or lactating women;
研究组 & 干预措施
Azacytidine combined with chidamide
Patients in the experimental arm will received azacytidine plus chidamide treatment. This regimen was repeated every 28 days.
干预措施: Azacitidine (Drug)
Azacytidine combined with chidamide
Patients in the experimental arm will received azacytidine plus chidamide treatment. This regimen was repeated every 28 days.
干预措施: Chidamide (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 1year
ORR was defined as the proportion of patients who achieved CR or PR as their best response
次要结局
- progression-free survival (PFS)(1 year)
- Duration of response (DOR)(through study completion, an average of 1 year)
- overall survival (OS)(through study completion, an average of 2 year)
- Adverse Events(During the whole treatment)