NCT01252784Unknown不适用
Reduced-intensity Conditioning Allogeneic Hematopoietic Cell Transplantation Followed by Prophylactic Dose-escalating Donor Lymphocyte Infusions in Higher Risk Myelodysplastic Syndrome
Cooperative Study Group A for Hematology1 个研究点 分布在 1 个国家目标入组 20 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
- 20
- 试验地点
- 1
- 主要终点
- relapse incidence,duration of remission
研究概览
简要总结
The purpose of this study is to evaluate the feasibility and efficacy of reduced-intensity conditioning allogeneic HCT followed by prophylactic dose-escalating DLIs in patients with higher risk MDS.
详细描述
Conditioning therapy
- Busulfan 3.2 mg/kg/d on d-7 to -6
- Fludarabine 30 mg/m2 on d-7 to -2
- ATG 1.5-3.0 mg/kg/d on d-3 to -1
- Methylpred 2 mg/kg/d on d-4 to -1
Mobilization and harvest
- Donor
- G-CSF 10 mcg/kg/d s.c. on d-3 to 0
- Harvest of PBMCs on d 0 to +1
Infuse G-PBMCs on d 0 to d+1.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with higher risk MDS including chronic myelomonocytic leukemia
- •RAEB-1 or RAEB-2
- •IPSS Intermediate-2 or High risk category
- •Chronic myelomonocytic leukemia
- •Patients with appropriate hematopoietic cell donor
- •HLA-matched sibling
- •HLA-matched unrelated donor
- •HLA-mismatched familial donor 3.16 years old or older
排除标准
- •• Presence of significant active infection
- •Presence of uncontrolled bleeding
- •Any coexisting major illness or organ failure
- •Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
结局指标
主要结局
relapse incidence,duration of remission
时间窗: 4years
The efficacy of the treatment will be measured in terms of relapse incidence and duration of remission (the primary endpoints). The hematopoietic cell donors in the study will include HLA-matched sibling, HLA-matched unrelated donors, and HLA-mismatched familial donors.
次要结局
- engraftment, donor chimerism, secondary graft failure,GVHD(4 years)
研究者
研究点 (1)
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