NCT00437450Unknown2 期
Treatment of the Anemia of Myelodysplastic Syndromes by the Association of Epoetin Beta and All Trans Retinoic Acid
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 99
- 试验地点
- 48
- 主要终点
- To evaluate the efficacy of association of Erythropoetin and ATRA in patients with low risk myelodysplastic syndromes
研究概览
简要总结
The purpose of this study is
- To evaluate the efficacy of association of Erythropoetin (Neorecormon) and ATRA in patients with low risk myelodysplastic syndromes
- To evaluate the tolerance of this treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Patients ≥18 years with RA, RARS, RAEB (blasts <10%)
- •Hb< 10g/dl > of 2 months or transfused since less 2 months
- •Hb<12g/dl > of 2 months and thrombocytopenia defined by platelets < 50 000/mm3, or neutropenia<10 000mm3
- •For women of child bearing age, necessity of contraception during all the duration of the study
排除标准
- •Patient with lung disease, cardiac, neurological, gastro-intestinal or genito - urinary disorders not connected to genito -urinary not connected to myelodysplasia
- •Patient having received intensive chemotherapy in the 3 months before inclusion in the protocol
- •RAEB >10% blasts
- •Treatment with rHu-Epo, darbepoetin ou rHu-GCSF , 2 months before inclusion
- •Patient presenting an iron , B12 vitamin or folic acid uncorrected deficit
- •Uncontrolled systemic hypertension
- •creatinine clearance < 300 µM/L
- •Pregnant patient or in period of lactation
- •Life expectancy < 6 months
结局指标
主要结局
To evaluate the efficacy of association of Erythropoetin and ATRA in patients with low risk myelodysplastic syndromes
次要结局
- To evaluate the tolerance of this treatment
研究者
研究点 (48)
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