Pharmacokinetic Study of Intravenous Busulfan as Conditioning Regimen for Allogeneic Stem Cell Transplantation in Adult Patients With Acute Leukemia
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Area Under Curve (AUC)
研究概览
简要总结
Intravenous Busulfan (iv-Bu) is commonly used as part of preparation regimen for allogeneic hematopoietic stem cell transplantation for patients with acute leukemia. Though the pharmacokinetics data are available for population from America, Europe and Japan or Korea in Asia, there are no data in Chinese population. It is shown that high Bu concentration are associated with the toxicity such as veno-occlusion disease and lower concentration is correlated with reduced anti-leukemia effect, thus the monitoring of Bu and/or the strategy to achieve an optimal target Bu concentration are accepted to avoid toxicity while maintain the anti-leukemia effect which may overall improve the outcome of allo-SCT. Thus we conduct the pharmacokinetic study in Chinese population.
详细描述
All patients received intravenous Busulfan based conditioning regimen for allogeneic stem cell transplantation.
Intravenous Busulfan (iv-Bu) was given 1.6mg/kg twice daily for 4 days as in the conditioning regimen.
Blood samples were obtained after first and 7th dose of iv Bulsulfan.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient with acute myeloid or lymphoblastic leukemia in 1st or second remission
- •age 18-55 years
- •with inform consent
- •no contraindication for allogeneic transplantation: active infection, allergy to FLu/Bu/CTX, liver and renal function damage
- •HLA matched related (6/6) or unrelated donors (at least 8/10)
排除标准
- •age less than 18 years or over 56 years
- •HLA mismatched related donor
- •liver function/renal function damage (over 2 X upper normal range)
- •with mental disease
研究组 & 干预措施
Iv-Busulfan
iv busulfan 1.6mg/kg given q12h
干预措施: Busulfan (Drug)
结局指标
主要结局
Area Under Curve (AUC)
时间窗: predose, 0,1,2,3,4,6,8,12,24,48,72, 96 hours post-dose
busulifan blood concentration
次要结局
未报告次要终点
研究者
Jiong HU
Head, Blood &^ Marrow Transplantation Center
Shanghai Jiao Tong University School of Medicine