NCT01854567已完成3 期
A 1-Year, Multicenter, Randomized, Open-Label Controlled Study to Evaluate the Efficacy and Safety of Cord Blood Cells Expanded With MPCs for Hematopoetic Recovery in Patients With Hematologic Malignancies After Myeloablative Treatment
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 9
- 主要终点
- Time to Neutrophil and Platelet Engraftment
研究概览
简要总结
The study investigates the time to engraftment of a mesenchymal expanded cord blood unit in patients with hematologic malignancies undergoing transplantation with myeloablative conditioning.
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
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must have one of the following:
- •Acute myelogenous leukemia (AML) in complete morphological remission at study screening (Complete Remission with Incomplete Platelet Recovery (CRp) acceptable).
- •Acute lymphoblastic leukemia (ALL) in complete morphological remission at study screening (Complete Remission with Incomplete Platelet Recovery (CRp) acceptable).
- •Non-Hodgkin's lymphoma (NHL): High risk subjects with responsive disease after first relapse. High risk includes those with Burkitt's Lymphoma and those with extensive marrow involvement at diagnosis-precluding autologous transplant.
- •Hodgkin's disease: High risk subjects with responsive disease after first relapse.
- •Minimum Karnofsky Scale
- •Subject must weigh at least 20 kg
- •Up to 65 years of age
- •Adequate major organ system function
排除标准
- •Pregnancy and/or lactating
- •Suitable, 6/6 HLA matched related sibling donor available
- •Previous participation in a stem cell study within last 30 days
研究组 & 干预措施
Active
Experimental
Infusion of one MPC expanded cord unit and one unexpanded cord unit.
干预措施: Infusion of one MPC expanded cord unit and one unexpanded cord unit (Biological)
Control
Active Comparator
Infusion of two unexpanded cord blood units.
干预措施: Infusion of two unexpanded cord blood units. (Biological)
结局指标
主要结局
Time to Neutrophil and Platelet Engraftment
时间窗: 100 days
次要结局
- Percentage of patients with primary graft failure(100 days)
- Proportion of subjects with neutrophil recovery at day 26, platelet recovery at day 60 and subjects alive at day 100(100 days)
研究者
研究点 (9)
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