Treatment of Anemia With Epoetin Beta in Low Risk Myelodysplastic Syndrome With Analysis of the Impact on Quality of Life and Functional Capacity of Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 31
- 主要终点
- Assess the level of haematological response according to IWG 2006 criteria with a pattern of administration of high doses epoetin beta (NeoRecormon ®) for 12 and 24 weeks of treatment
研究概览
简要总结
Chronic anemia is the symptom most frequently found at diagnosis in low risk myelodysplastic syndrome. It generates an increased rate of morbidity and mortality in this population of patients whose median age is high and the rate of co-mobidities important. The historical treatment is limited to transfusion support with a significant impact on quality of life and the incidence of secondary haemosiderosis, which contributes to the emergence of co-morbidities, especially cardiovascular. Treatment with rHuEPO allows for overall erythroid response in 40-60% of patients treated.
In this trial, the investigators intend to study the interest of a treatment with epoetin beta in patients with anemia <10 g / dL in the context of a myelodysplastic syndrome with IPSS score <1.
In addition to studying the erythroid response, the investigators will measure the impact on quality of life and functional performance.
Patients will receive epoetin beta (60 000UI/week). Response will be assessed after 12 and 24 weeks of treatment.
详细描述
Objective of the trial Assess the level of haematological response according to IWG 2000 and IWG 2006 criteria with a pattern of administration of high doses epoetin beta (NeoRecormon ®) for 12 and 24 weeks of treatment;
To evaluate the predictive value of the rate of reticulocytes at Day 8 on the erythroid response;
- Assess time to response
- Assess tolerance
- Assess the impact on quality of life using the FACT-An and EQ-5D measurement scales;
- Assess functional capacity:
Cardiovascular performance on effort by the 6-minute walk test Performing the " Short Physical Performance Battery " tests
Evaluation The evaluation of response according to the IWG 2000 and IWG 2006 criteria will be held at 12 and 24 weeks of treatment
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Must be 18 years of age or older at the time of screening
- •Myelodysplastic Syndrome of the following subtypes : RA, RAS, RCMD, RCMD-RS, RAEB 1, with IPSS score low or intermediate 1 (IPSS score < 1 ) and with anemia defined by Hb < 10 g/dl (with RBC transfusion requirement or not)
- •For women of childbearing potential, need for effective contraception throughout the study period.
排除标准
- •Intensive Chemotherapy within 3 months before inclusion
- •Myelodysplastic Syndrome with IPSS score >1
- •Treatment with rHu-Epo or rHu-GCSF within 2 months before inclusion
- •EGOG > 3 ;
- •Other causes of anemia (eg. , Iron deficiency, vitamin B12 or folic acid, hypothyroidism before correction)
- •Uncontrolled arterial hypertension
- •Life expectancy less than 6 months
- •Pregnant or breast feeding female subjects
- •Patients with creatinine clearance less than 30ml/min.
研究组 & 干预措施
epoetin beta
干预措施: Epoetin beta (NeoRecormon) (Drug)
结局指标
主要结局
Assess the level of haematological response according to IWG 2006 criteria with a pattern of administration of high doses epoetin beta (NeoRecormon ®) for 12 and 24 weeks of treatment
时间窗: 12 and 24 weeks
次要结局
未报告次要终点