A Study of Darbepoetin Alfa in Patients With Myelodysplastic Syndrome (MDS)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- hemoglobin and/or red blood cell (RBC) transfusion-dependence.
研究概览
简要总结
The primary objectives of the trial are to assess erythroid response to darbepoetin alfa, as determined by changes in hemoglobin and/or red blood cell (RBC) transfusion-dependence and to describe the safety profile of darbepoetin alfa in patients with MDS. The secondary objective is to assess bone marrow progenitor BFU-E growth before and after treatment with darbepoetin alfa.
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
- •Diagnosis:
- •Bone marrow aspirate/biopsy-proven MDS for > 2 months prior to enrollment.
- •MDS French-American-British (FAB) subtypes refractory anemia (RA), RA with ringed sideroblasts (RARS), RA with excess blasts (RAEB), and non-proliferative chronic myelomonocytic leukemia (CMML) [WBC < 12,000/ml].
- •Patients must have an untransfused hemoglobin < 10.0 g/dL and/or patients must be red cell transfusion-dependent for a period of at least 2 months prior to study entry.
- •Laboratory:
- •Bilirubin < or = to 2 mg/dL
- •ALT/SGPT < or = to 2.5 x the upper limit of normal (ULN)
- •Normal renal function (Stanford: serum creatinine < 1.2 mg/dL [male], < 1.0 mg/dL [female]; Vanderbilt: < 1.5 mg/dL).
- •Age: > or = to 18
- •ECOG performance status 0-
- •Patients may receive standard supportive care, including transfusions and antibiotics as required.
- •Patients must be r-HuEPO naive or must not have received prior treatment with r-HuEPO > or = to 40,000 U/week for more than 4 weeks.
排除标准
- •Patients with secondary MDS or prior allogeneic bone marrow transplant.
研究组 & 干预措施
Darbepoetin alfa
During the induction phase, the investigational agent DARBEPOETIN ALFA will be initiated at a dose of 4.5 ug/kg/week subcutaneously for 6 weeks. The dosage for the remaining treatment is dependent of patients response during the induction phase.
干预措施: Darbepoetin alfa (Drug)
结局指标
主要结局
hemoglobin and/or red blood cell (RBC) transfusion-dependence.
To assess erythroid responses to DARBEPOETIN ALFA, as determined by changes in
次要结局
- To assess bone marrow progenitor BFU-E growth before and after treatment
- DARBEPOETIN ALFA
研究者
Peter L Greenberg
Professor Emeritus
Stanford University