NCT01779882已完成不适用
Cyclophosphamide-Busulfan Versus Busulfan-Cyclophosphamide as Conditioning Regimen Before Allogeneic Hematopoietic Stem Cell Transplantation for Leukemia: a Prospective Randomized Study to Assess Liver Toxicity
University Hospital, Basel, Switzerland3 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 3
- 主要终点
- Liver toxicity
研究概览
简要总结
The aim of this study is to test the hypothesis, that the order of application of Busulfan (BU) and Cyclophosphamide (CY) has an impact on toxicity after allogeneic Hematopoietic stem cell transplantation (HSCT) and that CY-BU reduces liver toxicity compared to BU-CY.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients planned to undergo an allogeneic HSCT with myeloablative conditioning
- •Age 18 - 65 years
- •Myeloid leukemia respectively related precursor neoplasms (acute myeloid leukemia, chronic myeloid leukemia, myelodysplastic syndrome), or lymphoid neoplasms (acute lymphoblastic leukemia/lymphoma, mature B-/T-/natural killer (NK)-cell neoplasms).
- •Human Leukocyte Antigen (HLA)-identical sibling donor or matched unrelated (min. 10/10 Ag matched)
- •Patients with a history of hepatitis might be included, if no contraindication for HSCT exists.
- •Patient must give written informed consent
排除标准
- •Indication other than myeloid leukemia respectively related precursor neoplasms, or lymphoid neoplasms.
- •Severe liver damage for > 2 weeks (bilirubin > 3xupper limit normal (ULN) or ASAT/ALAT > 5xULN)
- •HIV infection
- •Donor other than HLA-identical sibling or min. 10/10 matched unrelated donor
- •Pregnant or lactating women
- •Lack of written informed consent
研究组 & 干预措施
BU-CY
Active Comparator
Group A (standard group): conditioning regimen with Busulfan (BU) followed by Cyclophosphamide (CY)
干预措施: Busulfan-Cyclophosphamide as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell Transplantation (Drug)
CY-BU
Experimental
Group B (experimental group): conditioning regimen with Cyclophosphamide (CY) followed by Busulfan (BU)
干预措施: Cyclophosphamide-Busulfan as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell Transplantation (Drug)
结局指标
主要结局
Liver toxicity
时间窗: Day 30
Liver toxicity, assessed as absolute serum values of ASAT, ALAT, GGT, Alkaline Phosphatase, bilirubin at day 30.
次要结局
- VOD(Day 30)
- Acute graft-versus-host disease (GvHD)(Day 30 and Day 100)
- Efficacy(Day 30 and Day 100)
- Toxicity(Day 30 and Day 100)
- Maximum liver values(Day 0, 10, 20 and 30)
- Cumulative liver values(Day 0, 10, 20 and 30)
研究者
研究点 (3)
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