Idarubicin+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Intermediate-risk Acute Myeloid Leukemia Undergoing Autologous Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- leukemia relapse rate
研究概览
简要总结
Autologous hematopoietic stem cell transplantation (Auto-HSCT) is an effective alternative to allogeneic HSCT for intermediate-risk acute myeloid leukemia (AML) without HLA-matched donors. At present, the best conditioning regimen for AML undergoing auto-HSCT remains in discussion. In this study, the safety and efficacy of IDA+BUCY and BUCY myeloablative conditioning regimens in intermediate-risk AML undergoing auto-HSCT are evaluated.
详细描述
Auto-HSCT is an effective alternative to allogeneic HSCT for intermediate-risk AML without HLA-matched donors. BUCY conditioning regimen is the standard myeloablative regimen. However, auto-HSCT with BUCY conditioning regimen appears to have higher relapse rate. To reduce the relapse rate, IDA is added in the conditioning regimen. In this study, the safety and efficacy of IDA+BUCY and BUCY myeloablative conditioning regimens in intermediate-risk AML patients undergoing auto-HSCT are evaluated.
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
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intermediate-risk AML
- •Achieving CR after one cycle induction,then receiving three cycles of consolidation therapy including moderate and high doses of Ara-c combined regimens
- •With negative MRD before mobilization and collect of peripheral blood stem cells
- •Without HLA-matched donors (related and unrelated)
- •Refusal of haploidentical hematopoietic stem cell transplantation
排除标准
- •Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
- •Patients with any conditions not suitable for the trial (investigators' decision)
研究组 & 干预措施
IDA+BUCY
For intermediate-risk AML undergoing auto-HSCT，IDA+BUCY conditioning regimen was IDA 15mg/m2/day on days -12 and -10；BU 3.2 mg/kg/day on days -7 and -4；CY 60 mg/kg/day on days -3 and -2.
干预措施: Idarubicin（IDA） (Drug)
IDA+BUCY
For intermediate-risk AML undergoing auto-HSCT，IDA+BUCY conditioning regimen was IDA 15mg/m2/day on days -12 and -10；BU 3.2 mg/kg/day on days -7 and -4；CY 60 mg/kg/day on days -3 and -2.
干预措施: Busulfan (BU) (Drug)
IDA+BUCY
For intermediate-risk AML undergoing auto-HSCT，IDA+BUCY conditioning regimen was IDA 15mg/m2/day on days -12 and -10；BU 3.2 mg/kg/day on days -7 and -4；CY 60 mg/kg/day on days -3 and -2.
干预措施: Cyclophosphamide (CY) (Drug)
BUCY
For intermediate-risk AML undergoing auto-HSCT，BUCY conditioning regimen was BU 3.2 mg/kg/day on days -7 and -4；CY 60 mg/kg/day on days
-3 and -2.
干预措施: Busulfan (BU) (Drug)
BUCY
For intermediate-risk AML undergoing auto-HSCT，BUCY conditioning regimen was BU 3.2 mg/kg/day on days -7 and -4；CY 60 mg/kg/day on days
-3 and -2.
干预措施: Cyclophosphamide (CY) (Drug)
结局指标
主要结局
leukemia relapse rate
时间窗: 2 year
次要结局
- overall survival (OS)(2 year)
- disease-free survival (DFS)(2 year)
- transplant-related mortality (TRM)(2 year)
研究者
Qifa Liu
Professor
Nanfang Hospital, Southern Medical University