NCT00355407已完成不适用
A Pilot Study of Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Evaluate the percentage of patients achieving a target hemoglobin of 11 g/dL or greater by day 100 following allogeneic stem cell transplantation.
研究概览
简要总结
The purpose of this study is to find out if Darbepoetin alfa is effective in treating low red blood cell levels after allogeneic stem cell transplant. Darbepoetin alfa has been shown to help raise red blood cell levels without blood transfusions.
详细描述
- Participants will receive Darbepoetin alfa through an injection under the skin, about 28-35 days after their allogeneic stem cell transplant. They will continue to receive the study drug once every three weeks for a maximum of four doses.
- Blood tests will be performed at weeks 3, 6, 9 and 12. The blood tests done at week three will check to make sure the participant has enough iron in their system. If not, they will need to take an iron supplement. Participants will also take a folate supplement to help cell growth and reproduction.
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
- Treatment
- 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
- •Hematologic malignancies undergoing ablative allogeneic stem cell transplantation for any indication
- •18 years of age or older
- •Hgb of less than 10 g/dL at the time of initiation therapy
排除标准
- •Known hypersensitivity reaction to darbepoetin alfa or any of its components
- •Transfusion of packed red blood cells within 3 days of initiation of treatment with darbepoetin alfa
- •Any history of grade III or IV GVHD
- •Use of any erythropoietic growth factor since transplantation
- •Uncontrolled hypertension
- •History of seizure
- •Baseline creatinine greater than 2
- •Dialysis dependence at the time of enrollment
- •Hemolytic uremic syndrome
- •Active GI bleeding
- •Concurrent autoimmune hemolytic anemia
- •Concurrent unstable angina
- •History of congenital hypercoagulable state or previous venous or arterial thrombosis
- •Relapsed disease prior to the initiation of study treatment
- •History of renal cell carcinoma
结局指标
主要结局
Evaluate the percentage of patients achieving a target hemoglobin of 11 g/dL or greater by day 100 following allogeneic stem cell transplantation.
次要结局
- Evaluate the percentage of patients achieving a greater than 1 g/dL hemoglobin increase between days 30 and 100 after allogeneic stem cell transplantation
- record transfusion requirements between days 30 and 100 in patients undergoing darbepoetin alfa administration following allogeneic stem cell transplantation.
研究者
研究点 (2)
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