Darbepoetin-alpha and i.v. Iron Administration After Autologous Hematopoietic Stem Cell Transplantation : a Prospective Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 4
- 主要终点
- Median time to achieve hemoglobin (Hb) level > 13 g/dL in each arm.
研究概览
简要总结
Darbepoetin-alpha and i.v. iron administration after autologous hematopoietic stem cell transplantation for hematological malignancies : a prospective randomized trial.
详细描述
- Outline:
A 3-arm prospective randomized study of darbepoetin alpha administration after autologous PBSC transplantation. Patients in the first arm will receive neither darbepoetin alpha nor i.v. iron. Patients in the second arm will receive darbepoetin alpha (Aranesp) alone starting on day 28 after the transplant. Patients in the third arm will receive darbepoetin alpha (Aranesp) and i.v. iron saccharate (Venofer). The plan is to include 25 patients in each arm.
In September 2006, all 75 planned patients have been included. Whereas preliminary analysis shows that Aranesp therapy significantly improves Hb recovery after autologous PBSC transplantation, the additional impact of Venofer therapy remains statistically not significant. However, this is a very important point, because Venofer therapy could potentially improve response and decrease the overall cost of treatment. Therefore, to increase the statistical power of the study, 50 additional patients will be included. Randomisation will now become limited to arms 2 (Aranesp) and 3 (Aranesp + Venofer). 2. Randomization:
Patients will be randomized 1:1:1 between the "Control", "Aranesp alone" and "Aranesp + Venofer" arms. Randomization will be carried out following a computer-generated randomization list blinded for personnel involved in clinical care of the patients.
Randomization will be carried out centrally in Liège by faxing the inclusion form at the following number : 32-4-3668855. This should be done around day 21 post-transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 69 Years（Child, 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
2
Aranesp 300 µg/15 days
干预措施: Darbepoetin alpha (Aranesp) (Drug)
3
Aranesp 300 µg/15 days. Venofer 200 mg on days 28, 42, and 56 after the transplant.
干预措施: Darbepoetin alpha (Aranesp) (Drug)
3
Aranesp 300 µg/15 days. Venofer 200 mg on days 28, 42, and 56 after the transplant.
干预措施: Iron saccharate (Venofer) (Drug)
结局指标
主要结局
Median time to achieve hemoglobin (Hb) level > 13 g/dL in each arm.
时间窗: 126 days after hematocrit (HCT)
Proportion of complete correctors (i.e. patients reaching Hb > 13 g/dL) before day 126 in each arm.
时间窗: 126 days after HCT
次要结局
- Median time to increase Hb level by > 2 g/dL in each arm.(126 days after HCT)
- Proportion of responders (i.e. patients increasing Hb by > 2 g/dL) before day 126 in each arm.(126 days after HCT)
- Proportion of correctors (i.e. patients reaching Hb > 12 g/dL) before day 126 in each arm.(126 days after HCT)
- Proportion of patients requiring red blood cell transfusions between day 28 and day 126 in each arm.(126 days after HCT)
- Total number of red blood cell transfusions between day 28 and day 126 in each arm.(126 days after HCT)
- Area under the curve of mean Hb level between day 28 and day 126 after the transplant in each arm.(126 days after HCT)
- Mean Hb values on days 42, 56, 70, 84, 98, 112, and 126 in each arm.(126 days after HCT)
- Mean change in Quality Of Life (QOL) measurements between day 28 and day 126 in each arm.(126 days after HCT)