A Phase I/II Study of the Safety and Pharmacokinetics of Opebacan (rBPI21) in Patients Undergoing Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 主要终点
- Time to engraftment
研究概览
简要总结
The objectives of this study are as follows:
To demonstrate the safety of escalating doses of opebacan in subjects undergoing myeloablative allogeneic Hematopoietic Stem Cell Transplantation
To determine the pharmacokinetics of opebacan in subjects undergoing myeloablative allogeneic Hematopoietic Stem Cell Transplantation
To determine if IV administration of opebacan is associated with changes in biological markers for inflammation
To develop preliminary descriptive data on the occurrence and severity of Hematopoietic Stem Cell Transplantation related complications, including aGvHD
详细描述
IV infusion of opebacan to replace endogenous BPI during the peritransplant period will result in the reduction of LPS-induced inflammatory sequelae, in particular aGvHD, in patients undergoing allogeneic HSCT.
The rationale for using opebacan in patients undergoing myeloablative regimens and HSCT is based on the following:
Endotoxemia has been demonstrated to play a central pathophysiologic role as a trigger of aGvHD in animal models.
Endotoxemia following HSCT is associated with inflammatory conditions (such as inflammatory cytokine release) that have been demonstrated in humans to be associated with organ damage and increased morbidity and mortality.
Endotoxemia and LBP elevation have been demonstrated in humans undergoing ablative HSCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age <= 60 and undergoing allogeneic HSCT
- •Life expectancy > 8 weeks
- •Scheduled for treatment with a conditioning regimen intended to be myeloablative
- •Female subjects of child-bearing age must have a negative urine pregnancy test. Sexually active male and female subjects of reproductive age must be using a form of contraception considered effective and medically acceptable by the Investigator.
排除标准
- •Cumulative lifetime exposure of > 300 mg/M2 of anthracycline (expressed as doxorubicin equivalent dose) or receipt of anthracycline within 180 days prior to initiating conditioning for HSCT
- •Active infection
- •Prophylactic antibacterial antibiotics.
- •Positive for HIV, HTLV-I, or HTLV-II
- •Any prior stem cell transplant
- •Prior history of CHF
- •Cord blood is the source of a subject's transplanted cells.
研究组 & 干预措施
Opebacan
干预措施: Opebacan (Drug)
结局指标
主要结局
Time to engraftment
时间窗: 100 days
Inflammatory markers
时间窗: 100 days
Inflammatory states
时间窗: 100 days
Transplant-related complications
时间窗: 100 days
The pharmacokinetics of opebacan
时间窗: 100 days
次要结局
未报告次要终点