NCT00888316已完成不适用
Iron Overload in Allogeneic Hematopoietic Cell Transplantation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
RATIONALE: Learning about the effect of excess iron in the liver of patients undergoing donor stem cell transplant may help doctors plan treatment.
PURPOSE: This study is investigating the effects of iron overload in patients undergoing donor stem cell transplant.
详细描述
OBJECTIVES:
Primary
- Determine the impact of pre-transplant iron overload (defined as liver iron concentration [LIC] above normal [> 1.8 mg/g] on an MRI of the liver measuring tissue proton transverse relaxation rates [R2 MRI]) on the probability of 1-year overall survival of patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT).
Secondary
- Determine the impact of pre-transplant iron overload on the composite endpoint of non-relapse mortality and complications (e.g., serious infections, hepatic veno-occlusive disease, or organ failure) within 1 year after allogeneic HSCT.
- Determine the impact of pre-transplant iron overload on the 1-year cumulative incidence of acute or chronic graft-vs-host disease in patients with acute leukemia or myelodysplastic syndromes undergoing allogeneic HSCT.
- Determine the impact of pre-transplant iron overload on the 1-year probability of overall survival and non-relapse mortality in patients undergoing allogeneic HSCT.
- Determine the prevalence of pre-transplant iron overload in adult patients undergoing allogeneic HSCT.
- Determine the correlation between pre-transplant ferritin levels and LIC on R2 MRI.
- Compare the longitudinal measures of serum ferritin levels after allogeneic HSCT in patients with iron overload vs those without iron overload.
- Estimate the cumulative incidence of iron overload at 1 year after allogeneic HSCT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planning to undergo allogeneic hematopoietic stem cell transplantation using either myeloablative or reduced-intensity conditioning
- •Any diagnosis allowed
- •Not pregnant
- •Weight ≤ 350 lbs
- •Must be able to give written informed consent indicating the investigational nature of the study and its potential risks.
排除标准
- •Claustrophobia
- •Other contraindication for MRI (e.g., cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, carotid artery vascular clamp, neurostimulator, insulin or infusion pump, or implanted drug infusion device)
结局指标
主要结局
Overall Survival
时间窗: 1 Year
Number of patients alive at 1 year.
次要结局
- Ferritin levels and Liver Iron Concentration(Baseline, and 3, 6, 9, and 12 Months Post Transplant)
- Number of Patients with Iron Overload(Baseline)
- Incidence of non-relapse mortality(Up to 1 Year)
- Acute and chronic graft-vs-host disease(1 Year Post Transplant)
- Longitudinal averages of serum ferritin levels(Post Transplant)
- Overall survival and non-relapse mortality(1 Year Post Transplant)
- Incidence of iron overload(1 Year Post Transplant)
研究者
研究点 (1)
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