A Historically-controlled, Multi-center Study to Assess the Safety and Efficacy of Tacrolimus (Prograf Capsule, Prograf Injection) and Methotrexate Combination Therapy for Prevention of GVHD in Patients Who Received Peripheral Hematopoietic Stem Cell Transplantation From a Sibling Donor
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 39
- 主要终点
- Number of occurrence sites of acute GVHD occurring within 100 days after peripheral hematopoietic stem cell transplantation from a sibling donor
研究概览
简要总结
The objective of this study is to assess the safety and efficacy of Tacrolimus (Prograf capsule, Prograf injection) and Methotrexate combination therapy for GVHD prophylaxis in patients who received peripheral hematopoietic stem cell transplantation from a sibling donor, and to compare with data from a historical control group that administered a conventional Cyclosporine formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Blood diseases for a standard risk group
- •Primary remission of AML (acute myeloid leukemia)
- •Primary remission of ALL (acute lymphocytic leukemia)
- •Secondary remission of ALL (acute lymphocytic leukemia)
- •SAA (severe aplastic anemia)
- •Chronic stage CML (chronic myeloid leukemia)
- •MDS (myelodysplastic syndrome)
- •Myeloma (multiple myeloma)
- •A patient who received peripheral hematopoietic stem cell transplantation from a HLA-matched sibling donor
排除标准
- •A patient with renal impairment (serum creatinine level ≥ 1.5mg/dl or 130μmol/l, GFR≤ 30%)
- •A pregnant or breastfeeding woman
- •A woman who is unwilling or unable to practice appropriate contraception during the study
- •A patient who is highly likely to experience aggravation during treatment due to active tuberculosis, other hepatic disease, hypertension, heart failure, chronic obstructive respiratory disease, etc.
- •A patient with hypersensitivity to tacrolimus
研究组 & 干预措施
Prograf + MTX
干预措施: Prograf (Drug)
Prograf + MTX
干预措施: Methotrexate (Drug)
Cyclosporine + MTX (historical control)
干预措施: Methotrexate (Drug)
Cyclosporine + MTX (historical control)
干预措施: Cyclosporine (Drug)
结局指标
主要结局
Number of occurrence sites of acute GVHD occurring within 100 days after peripheral hematopoietic stem cell transplantation from a sibling donor
时间窗: Day 1 up to Day 100 post-transplant
Severity of acute GVHD occurring within 100 days after peripheral hematopoietic stem cell transplantation from a sibling donor
时间窗: Day 1 up to Day 100 post-transplant
Severity is graded according to the Seattle criteria, between 1+ \~ 4+ depending on the severity of the injury of the skin, liver and digestive system, and the overall grade is classified by including the performance change.
Number of occurrence sites of chronic GVHD occurring after 100 days after peripheral hematopoietic stem cell transplantation from a sibling donor
时间窗: Day 100 up to 1 year post-transplant
Classification of chronic GVHD occurring after 100 days after peripheral hematopoietic stem cell transplantation from a sibling donor
时间窗: Day 100 up to 1 year post-transplant
Depending on the extent of occurrence, it is classified as limited (present only locally) and extensive (systemic lesions). Depending on the presence of preceding acute GVHD, it is classified as progressive for a patient with preceding acute GVHD (chronic GVHD following the occurrence of acute GVHD), quiescent (chronic GVHD after relief of acute GVHD symptoms) or otherwise (de novo).
Safety as assessed by adverse events
时间窗: Day 1 up to 1 year post-transplant
Safety as assessed by laboratory assessments
时间窗: Day 1 up to 1 year post-transplant
Includes hematology, biochemistry and trough plasma concentration analysis
次要结局
- Percentage of patients alive after peripheral hematopoietic stem cell transplantation from a sibling donor(Day 1 up to 1 year post-transplant)
- Percentage of patients alive after peripheral hematopoietic stem cell transplantation from a sibling donor in comparison with Cyclosporine in combination with MTX(Day 1 up to 1 year post-transplant)