NCT00804050终止3 期
Comparison Between Erythropoietin and Erythropoietin Associated to Differentiating Therapy With Acid 13-cis-retinoic and Dihydroxyvitamin D3 in Myelodysplastic Syndromes Without Excess of Blasts
Fondazione Italiana Sindromi Mielodisplastiche-ETS18 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2007年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 184
- 试验地点
- 18
- 主要终点
- study of comparison between standard theraphy rEPO (40.000unit/week) and association therapy between rEPO (40.000unit/week)plus Acid 13-Cis-Retinoic and Dihydroxyvitamin D3
研究概览
简要总结
This is a prospective, randomized multicenter phase III clinical trial designed to evaluate the safety and activity of comparison between Erythropoietin and Erythropoietin Associated to Differentiating Therapy With Acid 13-Cis-Retinoic and Dihydroxyvitamin D3 in Myelodysplastic Syndromes Without Excess of Blasts
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age higher than 18;
- •Confirmed diagnosis by osseous biopsy and bone marrow cyto-morphologic counts of blast cells, of Myelodysplastic syndrome without excess of blasts: "refractary anemia", "refractary anemia with rings sideroblasts", "refractary citopenya with multilineage dysplasia", " refractary citopenya with multilineage dysplasia and rings sideroblasts" or "5q-syndrome" without excess of blasts based on WHO classification (appendix).
- •Low or intermediate-1 IPSS (appendix).
- •Hb < 11g/dl.
- •rEPO serum level < 500mU/L.
- •Women in menopause from at least one year.
- •Informed consent
排除标准
- •Myelodisplastic syndrome with excess of blasts (RAEB).
- •IPSS score intermediate-2 or high (appendix).
- •Forecasted allogeneic bone marrow transplant within 1 year after diagnosis(patients younger than 60 years, transfusion dependents or with serious leuko/thrombocytopenia and HLA compatible family donor).Considering the time needed to perform this procedure, the indication of a transplant from non-consanguineous donor has no contraindication to the inclusion in this protocol of the response to rEPO therapy ± differentiating therapy.
- •Renal failure with creatininemia value greater than 3 times the normal limit.
- •Chronic hepatophaty with bilirubinemia value greater than 3 times the normal limit and/or AST or ALT or ALP values greater than 5 times the normal limit.
- •Presence of second tumor or other serious pathology with life expectancy lower than one year.
- •Presence of neurologic or psychiatric pathologies that make the patient unreliable in the acquisition of drugs.
- •Allergy/intolerance known to use drugs.
- •Pregnant women.
- •Women of childbearing age or in menopause from less than one year.
- •Age < 18 years old.
- •HIV positive.
研究组 & 干预措施
Infusion B combined r-EPO
Experimental
rEPO in association with acid 13-cis-retinoic acid and Dihydroxyvitamin D3 for 4 mounths consequently
干预措施: B Infusion rEPO combined with vitamins pills (Drug)
结局指标
主要结局
study of comparison between standard theraphy rEPO (40.000unit/week) and association therapy between rEPO (40.000unit/week)plus Acid 13-Cis-Retinoic and Dihydroxyvitamin D3
时间窗: After 8 months
次要结局
- To evaluate the quality of life improvement due to therapy.(8 mounths)
- To evaluate the percentage of leukemic progression.(20 mounths)
- TO evaluate if,the patients without eritroyd response at the end of the 4° month of therapy, the increase of dose of rEPO to 80.000 U / week allows to get an increase of valued response at the end of the 8° month.(8 months)
- To evaluate if there is a difference of duration in the eritroyd response with standard therapy rEPO in comparison with association therapy rEPO plus Acid 13-Cis-Retinoic and Dihydroxyvitamin D3.(20 mounths)
- To evaluate the existing relationships among eritroyd response and clinical-biological parameters at baseline of anemia, subclass of MDS, silky dosing of the EPO etc.(20 mounths)
研究者
研究点 (18)
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