A Study of Chidamide With AZA in MRD Positive AML After Transplant
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- the rate of RFS in 6 months
研究概览
简要总结
acute myeloid leukemia (AML) is a malignant tumor of the hematopoietic system with high heterogeneity in cytogenetics and molecular biology.Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is still the primary treatment option for patients with AML and the most effective method for radical treatment of AML.Despite considerable progress in allo-HSCT over the past decade, 30%-40% of patients still relapse, and post-transplant relapse remains the leading cause of death in patients with AML.
详细描述
Investigators proposed Chidamide combined with azacitidine as the prospective treatment for MRD-positive AML patients before and after transplantation, hoping to reduce the recurrence rate of transplantation and improve the transplantation effect. The efficacy and safety of the method will be verified by this clinical study.
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
- •Patients diagnosed with AML (diagnostic criteria refer to WHO2016 criteria, except M3) can detect small residual lesions (MRD) positive after allogeneic hematopoietic stem cell transplantation (allo-HSCT);
- •≥18 years old;
- •lifespan≥3 months;
- •Take contraceptive measures;
- •Sign informed consent.
排除标准
- •Allergic to the study drug;
- •A gastrointestinal condition that prevents oral medication;
- •active infection;
- •Dysfunction of vital organs;
- •other malignancies;
- •HIV infection;
- •HBV or HCV;
- •The QT interval is prolonged;
- •Pregnant or lactating women;
- •Is participating in other clinical studies;
- •The researchers did not consider it appropriate to participate in this study.
研究组 & 干预措施
chidamide and azacitidine
干预措施: chidamide and azacitidine (Drug)
结局指标
主要结局
the rate of RFS in 6 months
时间窗: 6 months
relapse-free survival
次要结局
- the rate of MRD turn negative in 6 months(6 months)
- the time length of MRD negative(24 months)
- the 1 year/2 year RFS(24 months)
- the 1 year/2 year OS(24 months)
- the rate of GVHD(24 months)
- Incidence of Treatment-Emergent Adverse Events(24 months)
研究者
WENG Jian yu
professor
Guangdong Provincial People's Hospital