NCT01159067终止2 期
Deferasirox Treatment and Labile Plasma Iron in Iron Overloaded Patients Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation
City of Hope Medical Center1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2010年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of Patients With Elevated Labile Plasma Iron (LPI) Above Threshold (0.5 Umol/L)
研究概览
简要总结
RATIONALE: Low dose deferasirox may be safe and effective in treating patients who have undergone hematopoietic stem cell transplant and have iron overload.
PURPOSE: This pilot clinical trial studies safety and tolerability of deferasirox in hematopoietic stem cell transplant recipients who have iron overload. Effect of low dose deferasirox on labile plasma iron is also examined.
详细描述
PRIMARY OBJECTIVES:
I. To determine labile plasma iron (LPI) levels in iron overloaded patients after allogeneic Hematopoietic Stem Cell Transplantation (HSCT).
II. To determine safety and tolerability of low dose deferasirox in the post allogeneic HSCT setting.
SECONDARY OBJECTIVES:
I. To determine ability of deferasirox to suppress LPI in allogeneic HSCT patients with serum ferritin over 1500 ng/ml.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
Experimental
Patients receive oral deferasirox once daily for up to 6 months in the absence of unacceptable toxicity.
干预措施: deferasirox (Drug)
结局指标
主要结局
Number of Patients With Elevated Labile Plasma Iron (LPI) Above Threshold (0.5 Umol/L)
时间窗: At baseline
次要结局
- Number of Patients With Serum Ferritin Level Lower Than 1500 ng/mL After Treatment(Assessed through 6 months from the start of treatment)
- Correlation of LPI With Serum Ferritin(Assessed through 6 months from the start of treatment)
- Number of Patients With LPI Below 0.5 Umol/L After Treatment(Assessed through 6 months from the start of treatment)
研究者
研究点 (1)
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