A Multi-center, Open, Randomized-control Study to Compare the Effects and Safety of Idarubicin-strengthened Pretreatment Program and Conventional Busulfan Cyclophosphamide Pretreatment Program on High-risk Acute Myeloid Leukemia Patient
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 2-year disease-free survival (DFS) rates
研究概览
简要总结
This study was a multi-center, open, randomized-control study on the effects and safety of idarubicin 60mg/M2 combined with BUCY pretreatment program or BUCY pretreatment program on the overall survival rate and disease-free survival rate of acute myeloid leukemia patient in high-risk group over a period of 2 years.
详细描述
This study was a multi-center, open, randomized-control study. It evaluates the effects and safety of idarubicin 60mg/M2 combined with BUCY pretreatment program or BUCY pretreatment program on acute myeloid leukemia patient in high-risk group. 200 patients were studied with 100 patients in each group.
Patients enrolled were randomly divided into group A (idarubicin 60mg/M2 combined with BUCY group) and group B (BUCY group). SAS randomization software was used to obtain randomization numbers. Patients were recommend to start pretreatment within 7 days after randomization.
Main objective: 2-year overall survival (OS) and disease-free survival (DFS) rates.
Secondary objective: safety evaluation (early complications of transplantation, liver, kidney and heart toxicity, treatment-related mortality, blood recovery time), the median period of disease-free survival.
Test drugs Idarubicin (Zavedos ®, Pfizer), busulfan, cyclophosphamide.
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18～50;
- •Received peripheral blood hematopoietic stem cell transplantation from siblings or unrelated allogeneic donors with identical matching of HLA or 1 alleles mismatched.
- •Diagnosis: refer to 2011 edition of AML China Guideline for the diagnosis and treatment and diagnosis standards of high-risk acute myeloid leukemia developed through literatures (see Appendix B);
- •Under general condition, ECOG score ≤ 1;
- •Normal cardiac functions;
- •Normal liver and renal function: blood bilirubin≤35 μ mol\/L, AST/ALT lower than twice in the upper limit of normal value, serum creatinine≤ 150 μ mol\/L;
- •Subjects have signed the informed consent form.
排除标准
- •Severe uncontrolled infection before transplantation;
- •With contraindications of idarubicin;
- •Reached the maximum cumulative dose of anthracyclines, for instance, DNR≥ 450mg/m2, mitoxantrone≥140mg/m2, the total cumulative dose of idarubicin≥ 300mg/m2;
- •The other conditions that do not meet the inclusion criteria.
- •Withdrawal criteria:
- •Those do not meet the inclusion criteria or meet the exclusion criteria after reviewing;
- •Patient withdraws the informed consent form;
- •Patient violates the clinical study protocol;
- •Patient experiences severe adverse events that treatment has to be terminated;
- •Patient that considered no longer fit to complete clinical trials by researchers.
研究组 & 干预措施
IDBUCY
Idarubicin: 20mg/m2 a day, d-12 ~d-10, intravenous infusion for 1 hour. Busulfan: 4mg/Kg a day, oral administration, d-7 ~d-4, or 3.2mg/Kg a day, intravenous infusion, d-7~d-4.
cyclophosphamide: 60mg/Kg a day, intravenous infusion, d-3~d-2.
干预措施: Cyclosporin A,mycophenolate mofetil,Methotrexate (Drug)
BUCY
Busulfan: 4mg/Kg a day, oral administration, d-7 ~d-4, or 3.2mg/Kg a day, intravenous infusion, d-7~d-4.
Cyclophosphamide: 60mg/Kg a day, intravenous infusion, d-3~d-2.
干预措施: Cyclosporin A,mycophenolate mofetil,Methotrexate (Drug)
结局指标
主要结局
2-year disease-free survival (DFS) rates
时间窗: 4 years
The purpose of this study is to evaluates the effects of idarubicin 60mg/M2 combined with BUCY pretreatment program or BUCY pretreatment program on acute myeloid leukemia patient in high-risk group.
次要结局
- 2-year overall survival (OS) rates(4 years)
研究者
Lan YongRong
Director of the Hematology department of the First Affiliated Hospital of Guangxi Medical University
Guangxi Medical University