NCT01930162已完成2 期
A Single-arm, Open-label Study to Evaluate the Safety and Tolerability of Infusing HSC835 in Patients With Hematological Malignancies Undergoing UCB Transplantation Using a Non-myeloablative Conditioning Regimen
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Absence of Graft Failure at Day 42
研究概览
简要总结
This study was designed to evaluate the safety and tolerability of HSC835 for clinical use as measured by the absence of graft failure at day 42 in excess of that currently observed with double umbilical cord blood (UCB) transplantation (DUCBT) with non-myeloablative (NMA) conditioning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis that qualifies them for UCBT
- •Adequate organ function
- •Availability of eligible donor material
排除标准
- •Pregnancy or breastfeeding women and women of child-bearing potential unless two acceptable forms of contraception are being used
- •Human immunodeficiency virus (HIV) infection
- •Active infection
研究组 & 干预措施
HSC835
Experimental
Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen.
干预措施: HSC835 (Drug)
结局指标
主要结局
Absence of Graft Failure at Day 42
时间窗: 42 days
This endpoint was to study safety and tolerability of HSC835 as measured by the absence of graft failure at day 42 in excess of that currently observed with double umbilical cord blood (UCB) transplantation (DUCBT) with non-myeloablative (NMA) conditioning.
次要结局
- Incidence of Overall Survival Within One Year(1 year)
- Incidence of Non-relapse Mortality (NRM) Within 100 Days and One Year(1 year)
- Incidence of Neutrophil Recovery Within 42 Days(42 days)
- Incidence of Relapse-free Survival Within One Year(1 year)
研究者
研究点 (1)
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