Combination of Azacitadine and Hematopoietic Growth Factors for Myelodysplastic Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of Participants With Complete Response
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of abnormal cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as darbepoetin alfa and G-CSF, may increase the number of red blood cells and white blood cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving azacitidine together with darbepoetin alfa and G-CSF may be an effective treatment for myelodysplastic syndromes.
PURPOSE: This clinical trial is studying how well giving azacitidine together with darbepoetin alfa and G-CSF works in treating patients with myelodysplastic syndromes.
详细描述
OBJECTIVES:
Primary
- Determine the hematological response rate in patients with myelodysplastic syndromes treated with azacitidine, darbepoetin alfa, and filgrastim (G-CSF).
Secondary
- Determine the time to leukemia progression, survival, and changes in apoptotic index of bone marrow in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 120 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
Azacitadine and Hematopoietic Growth Factors
Combination of Azacitadine andHematopoietic Growth Factors
干预措施: Azacitadine and Hematopoietic Growth Factors (Drug)
结局指标
主要结局
Number of Participants With Complete Response
时间窗: Approximately 112 days
Complete response is normalization of abnormal blood counts, and disappearance of signs of morphological changes in the bone marrow. If the previously present cytogenetic abnormalities are absent then it is referred also as a cytogenetic complete remission.
Rate of Major Hematological Improvement
时间窗: Approximately 112 days
For patients with pretreatment hemoglobin less than 11 g/dL, greater than 2 g/dL increase in hemoglobin; for red cell transfusion-dependent patients, transfusion independence.
次要结局
- Change in Bone Marrow Apoptosis(Baseline and approximately 12 months)
- Overall Survival(Approximately 12 months)
- Minor Hematological Improvements(Approximately 112 days)
- Expression of p53 and p21(Approximately 12 months)
- Time to Progression to Acute Myeloid Leukemia (Blast ≥ 20%) or Death(Approximately 12 months)