Tacrolimus/Methotrexate Versus Cyclosporine/Methotrexate for Prophylaxis of Graft Versus Host Disease in Paediatric Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- incidence of grade II-IV acute graft versus host disease
研究概览
简要总结
This study aims to compare efficacy and safety of tacrolimus/methotrexate with cyclosporine/methotrexate for graft versus host disease prophylaxis in paediatric allogeneic hematopoietic stem cell transplantation patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of hematological malignancy
- •Age under 18 years old
- •Serum bilirubin less than 1.5 X upper limit of normal
- •Aspartate transaminase, Alanine transaminase less than 2.5 X upper limit of normal
- •Alkaline phosphatase less than 2.5 X upper limit of normal
- •Serum creatinine less than 1.5 X upper limit of normal
- •Agrees to participate, and informed consent signed
排除标准
- •Evidence of HIV infection
- •Documented uncontrolled disease (infections)
- •Prior transplantation (hematopoietic stem cell or solid organs)
研究组 & 干预措施
Tacrolimus/Methotrexate
Tacrolimus D-1~D20: iv infusion, q24hr (first daily dose: 0.03mg/kg) D20~D100: po q12hr (first daily dose: the quadruple of last iv dose) Dose modification according to therapeutic drug monitoring(TDM) (10-20ng/ml)
Methotrexate D1: 15mg/m2 iv push D3,6,(11): 10mg/m2 iv push
干预措施: Tacrolimus (Drug)
Tacrolimus/Methotrexate
Tacrolimus D-1~D20: iv infusion, q24hr (first daily dose: 0.03mg/kg) D20~D100: po q12hr (first daily dose: the quadruple of last iv dose) Dose modification according to therapeutic drug monitoring(TDM) (10-20ng/ml)
Methotrexate D1: 15mg/m2 iv push D3,6,(11): 10mg/m2 iv push
干预措施: Methotrexate (Drug)
Cyclosporine/Methotrexate
Cyclosporine D-1~D20: iv infusion, q24hr (first daily dose: 3mg/kg) D20~D100: po q12hr (first daily dose: the 3 times of last iv dose) Dose modification according to TDM (200-300ng/ml)
Methotrexate D1: 15mg/m2 iv push D3,6,(11): 10mg/m2 iv push
干预措施: Cyclosporine (Drug)
Cyclosporine/Methotrexate
Cyclosporine D-1~D20: iv infusion, q24hr (first daily dose: 3mg/kg) D20~D100: po q12hr (first daily dose: the 3 times of last iv dose) Dose modification according to TDM (200-300ng/ml)
Methotrexate D1: 15mg/m2 iv push D3,6,(11): 10mg/m2 iv push
干预措施: Methotrexate (Drug)
结局指标
主要结局
incidence of grade II-IV acute graft versus host disease
时间窗: day 100 post transplantation
Overall grade I graft-versus-host disease denoted stage 1 to 2 skin involvement with no liver or gut involvement. Overall grade II graft-versus-host disease denoted stage 3 skin involvement or stage 1 liver or gut involvement. Overall grade III graft-versus-host disease denoted stage 4 skin involvement or stage 2 to 4 liver or gut involvement without graft-versus-host disease as a major contributing cause of death. And Overall grade IV graft-versus-host disease denoted stage 4 skin involvement or stage 2 to 4 liver or gut involvement with graft-versus-host disease as a major contributing cause of death.
次要结局
- incidence of infection(day 100 post transplantation)
- incidence of adverse drug reactions(day 100 post transplantation)
研究者
Hyoung Jin Kang
professor
Seoul National University Hospital