NCT03611231Unknown2 期
Chidamide Maintenance Treatment After Autologous Hematopoietic Stem Cell Transplantation in Patients With Relapsed, Refractory or High-risk Lymphoma : a Prospective, Multi-centric, Single Arm, Open Label Phase II Clinical Trial
Peking University1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2018年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- progression-free survival（PFS）
研究概览
简要总结
Chidamide Maintenance Treatment After Autologous Hematopoietic Stem Cell Transplantation in Patients With Relapsed, Refractory or High-risk Lymphoma : a Prospective, Multi-centric, Single Arm, Open Label Phase II Clinical Trial
详细描述
Chidamide，a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. The aim of this study was to observe the efficacy and safety of Chidamide as Maintenance Treatment After Autologous Hematopoietic Stem Cell Transplantation in Patients With Relapsed, Refractory or High-risk Lymphoma
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
- •Patients with B-NHL,NK/T-NHL and HL were confirmed by histopathology examination had received autologous hematopoietic stem cell transplantation (including secondary transplantation). Transplantation interval was 6-8 weeks before in the study. The first diagnostic risk classification or pre-transplant disease status of each type of lymphoma is as follows: 1)B-NHL: patients who are at high risk according to the corresponding international prognostic index in the first diagnosis(IPI>3 /aa IPI >2 /FLIPI>3); Patients must have received at least one first-line induction therapy but did not achieve CR or had relapse after CR; 2)NK/T-NHL: Including all patients, unlimited risk classification and pre-transplant disease status; 3)HL: Patients must have received at least one first-line induction therapy
- •Age 18-70 years, male or female;
- •ECOG performance status 0-1;
- •Organ function should fit the following : Renal function with serum creatinine < 160μmol/L; Liver function with Total bilirubin ≤2 times of normal maximum, ALT and AST≤3 times of normal maximum. Adequate pulmonary function with forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) ≥ 50% of expected corrected for hemoglobin. Adequate cardiac function with left ventricular ejection fraction ≥ 50%. No symptomatic cardiac disease;
- •Blood routine test: absolute neutrophil count ≥1.5×109/L, platelet ≥75×109/L, Hb ≥ 90g/L;
- •Life expectancy no less than 3 months;
- •Patients willing to sign the Informed Consent Form.
排除标准
- •Patients relapsed after ASCT
- •Patients with HBsAg positive or HBcAb positive patients also detected HBV-DNA copy number positive;
- •Patients with active HCV infection;
- •Patients with active HIV infection;
- •Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue disease, severe infectious diseases and others;
- •Patients with liver cirrhosis or evidence of liver fibrosis;
- •Patients with a QTc longer than 500 ms;
- •Patients with mental disorders or those do not have the ability to consent;
- •Patients with drug abuse, long term alcoholism that may impact the results of the trial;
- •Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures;
- •Non-appropriate patients for the trial according to the judgment of the investigators;
研究组 & 干预措施
Experimental
Experimental
chidamide
干预措施: Chidamide (Drug)
结局指标
主要结局
progression-free survival（PFS）
时间窗: up to 2 years
Time from treatment until disease progression or death
次要结局
- overall survival（OS）(up to 2 years)
- Treatment-related adverse events (AEs)(2 years)
研究者
Jun Zhu
Director
Peking University
研究点 (1)
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