To Evaluate Safety and Efficiency of AZA Combined With Chidamide as Maintenance Therapy in High-risk Acute Myeloid Leukemia Patients After Allogeneic Hematopoietic Stem Cell Transplantation：A Multicenter, Single-arm Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of Paticipants With Adverse Events as a Measure of Safety
研究概览
简要总结
The goal of this clinical research study is to learn if azacitidine combined with Chidamide will help to control the disease in patients with high-risk AML after an allogeneic stem cell transplant. The safety of this combination will also be studied.
详细描述
The Study Drug:
Azacitidine is designed to block certain genes in cancer cells whose job is to stop the function of the tumor-fighting genes. By blocking the "bad" genes, the tumor-fighting genes may be able to work better.
Chidamide exhibits potent inhibitory effect on cell viability of MDS and AML cells, and the possible mechanism may lie in the downregulation of JAK2/STAT3 signaling through SOCS3 upregulation.
Study Group： If you are found to be eligible to take part in this study,you will receive azacitidine and chidamide.
Study Drug Administration:
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Age 18 to 60 years old,both male and female
- •2.Be able to understand and sign informed consent
- •3.Patients with a diagnosis of AML not M3 according to the 2016 World Health Organization (WHO) Acute Myeloid Leukemia Classification and Diagnostic
- •4.Patients have AML with poor genetic abnormalities,primary refractory AML,relapsed AML or secondary AML
- •5.Patients with an ECOG performance status 0,1,2 or 3
- •6.Expected survival time ≥ 3 months
- •7.Non-hematological toxicity related to transplantation does not exceed Grade 2
- •8.Laboratory indicators meet the following standards:
- •7 days before the first day of the first course of treatment, bilirubin, ALT and AST were all less than 3 times the upper limit of normal.
- •Measure twice within 7 days before the first day of the first course of treatment, at least 2 days apart, the neutrophil count are greater than 1.5×10/L and without G-CSF treatment.
- •Measure twice within 7 days before the first day of the first course of treatment, at least 2 days apart, platelet count greater than 80×10/L and without platelet transfusion.
- •Serum creatinine clearance rate is greater than 30ml/min.
排除标准
- •1.Uncontrollable active infection
- •2.Patients with active hepatitis B or C or HIV infection before enrollment
- •3.Have a grade III-IV graft-versus-host disease
研究组 & 干预措施
Azacitidine combined with Chidamide
Patients will recieve six courses of azacitidine 50mg/m2 through a needle under your skin on Days 1-3.Each course is 28 days long.At the same time patients will recieve oral chidamide 5mg per day for no more than 2 years.
干预措施: Azacitidine (Drug)
Azacitidine combined with Chidamide
Patients will recieve six courses of azacitidine 50mg/m2 through a needle under your skin on Days 1-3.Each course is 28 days long.At the same time patients will recieve oral chidamide 5mg per day for no more than 2 years.
干预措施: Chidamide (Drug)
结局指标
主要结局
Number of Paticipants With Adverse Events as a Measure of Safety
时间窗: From the day of stem cell transplantation to one year after stem cell transplantation
Safety were measured with respect to: 1. Safety measurements 2. Incidence of adverse events
One year cumulative incidence of relapse
时间窗: From the day of stem cell transplantation to one year after stem cell transplantation
Leukemia relapse base on morphoogy criterion
次要结局
- Relapes-free Survival（RFS）(From the day of stem cell transplantation to one year after stem cell transplantation)
- Overall survival（OS）(From the day of stem cell transplantation to one year after stem cell transplantation)
- The cumulative Incidence rate of GVHD(From the day of stem cell transplantation to one year after stem cell transplantation)