Efficacy of Idarubicin, Cytarabine and Cyclophosphamide (IAC) Regimen in Relapsed/Refractory AML
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Complete Remission Rate
研究概览
简要总结
In this multi-center, randomized, open-label, prospective clinical trial, a total of 60 relapsed/refractory AML patients will be randomized into 2 groups. In the experimental arm, patients receive IAC regimen. In the control arm, patients receive other physician-directed regimen. The primary end point is complete remission rate.
详细描述
In this multi-center, randomized, open-label, prospective clinical trial, a total of 60 relapsed/refractory AML patients will be randomized into 2 groups. Patients in the IAC arm receive the therapy consisting of idarubicin 10 mg/㎡/d on days 1-3, cytarabine 100mg/㎡/d on days 1-7 and cyclophosphamide at a dose of 350mg/㎡/d on the second day and the fifth day. In the control arm, patients received other physician-directed regimen including fludarabine, cytarabine with/without granulocyte stimulating factor(FLA±G) regimen,cytarabine plus daunorubicin(DA）regimen , decitabine,aclacinomycin and cytarabine(decitabine plus AA) regimen or AA regimen plus granulocyte stimulating factor. All the regimen in the control arm can not contain cyclophosphamide. The primary end point is complete remission. The second end points include overall survival, relapse-free survival and time to treatment failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of less than 60 years old;
- •Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML (except APL subtypes).
- •Patients with a confirmed pathologic diagnosis of AML which had relapsed or refractory.
- •Patients with ECOG score of ≤ 2;
- •Adult patients are willing to participate in the study and sign the informed consent by themselves or by their immediate family. Patients under 18 years old willing to participate should have their legal guardians sign the informed consent.
排除标准
- •Patients who had received reinduction therapy including cyclophosphamide are excluded. However, patients who had received regimens including cyclophosphamide before relapse are eligible.
- •Patients with other blood diseases(for example, haemophiliacs) are excluded.
- •Relapsed patients with only extramedullary leukemia;
- •After allogeneic hematopoietic stem cell transplantation;
- •With mutation of breakpoint cluster region-Abelson(BCR-ABL) fusion gene and in need of tyrosine kinase inhibitors therapy;
- •Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;
- •Had other malignant tumor in need of treatment;
- •Had active cardiovascular disease;
- •Patients with other factors which were considered unsuitable to participate in the study by the investigators.
研究组 & 干预措施
IAC regimen
Patients receive IAC regimen including idarubicin, cytarabine and cyclophosphamide.
干预措施: Idarubicin (Drug)
IAC regimen
Patients receive IAC regimen including idarubicin, cytarabine and cyclophosphamide.
干预措施: Cytarabine (Drug)
IAC regimen
Patients receive IAC regimen including idarubicin, cytarabine and cyclophosphamide.
干预措施: Cyclophosphamide (Drug)
Control Group
Patients receive physician-directed regimens without cyclophosphamide including FLA±G regimen, AAG regimen, decitabine with AA regimen. Physicians can choose one of these regimens based on their experience and patients' condition.
干预措施: Physician-Directed Regimens without Cyclophosphamide (Drug)
结局指标
主要结局
Complete Remission Rate
时间窗: Within 6 weeks after induction therapy
次要结局
- Relapse-Free Survival(RFS)(Up to 3 years)
- Overall Survival(OS)(Up to 3 years)
- Time to Treatment Failure(TTF)(Up to 3 years)