NCT01255319Unknown不适用
Conditioning With Cyclophosphamide, Fludarabine and Antithymocyte Globulin for Allogeneic Hematopoietic Cell Transplantation in Lower Risk Myelodysplastic Syndrome
Cooperative Study Group A for Hematology1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2010年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- feasibility and efficacy
研究概览
简要总结
To evaluate the feasibility and efficacy of the conditioning regimen with cyclophosphamide, fludarabine and antithymocyte globulin (CyFluATG) for allogeneic hematopoietic cell transplantation (HCT) in patients with lower risk myelodysplastic syndrome (MDS).
详细描述
Conditioning therapy
- Cytoxan 50 mg/kg/d on d-3 to -2
- Fludarabine 30 mg/m2 on d-6 to -2
- Antithymocyte globulin (ATG; Thymoglobulin®) 1.5 mg/kg/d (for HLA-matched sibling donor HCT) or 3.0 mg/kg/d (for other alternative donor HCT)
- Methylpd 2 mg/kg/d on d-4 to -1
Mobilization and harvest
- G-CSF 10 mcg/kg/d s.c. on d-3 to 0
- Harvest of PBMCs on d 0 to +1
Donor G PBMC infusion
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with lower risk MDS (bone marrow blast percentage < 5%)
- •Patients with appropriate hematopoietic cell donor
- •Adequate performance status (Karnofsky score of 70 or more; see Appendix II)
- •Adequate hepatic and renal function (AST, ALT, and bilirubin < 3.0 x upper normal limit, and creatinine < 2.0 mg/dL).
- •Adequate cardiac function (left ventricular ejection fraction of 40% or more on heart scan or echocardiogram)
- •Signed and dated informed consent must be obtained from both recipient and donor.
排除标准
- •Presence of significant active infection
- •Presence of uncontrolled bleeding
- •Any coexisting major illness or organ failure
- •Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
- •Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
- •Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
结局指标
主要结局
feasibility and efficacy
时间窗: 4years
To evaluate the feasibility and efficacy of the conditioning regimen with cyclophosphamide, fludarabine and antithymocyte globulin (CyFluATG) for allogeneic hematopoietic cell transplantation (HCT) in patients with lower risk myelodysplastic syndrome (MDS). The efficacy of the treatment will be measured in terms of engraftment and non-relapse mortality (the primary endpoints)
次要结局
- progression-free survival, and overall survival(4 years)
研究者
研究点 (1)
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