NCT00488436已完成4 期
SMD/ATG-CSA: Antithymocyte Globulin and Cyclosporine in Treating Low Risk Patients With Myelodysplastic Syndrome
PETHEMA Foundation12 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2002年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 12
- 主要终点
- Compare the efficacy and toxicity of antithymocyte globulin and cyclosporine in patients with low risk myelodysplastic syndrome
研究概览
简要总结
The different mechanisms of action between Antithymocyte globulin and cyclosporine can improve the effectivity when both are used in combination in patients with myelodysplastic syndrome.
详细描述
Patients are treated with:
Antithymocyte globulin (Timoglobulin SangStat)
- 2,5 mg/kg/day IV over 8 hours on days 1-4
- Total dose: 10 mg/kg
- Calculated dose adjusted to ideal weight
- Especial considerations:
Paracetamol 1 gr (oral or IV) Dexclorfeniramine 5 mg IV Methylprednisolone 1 mg/kg IV 30 minutes before Timoglobulin and repeat if necessary at 4 hours - Platelet transfusion if platelet count is < 50 x 109/L
Cyclosporine (Sandimmun Neoral)
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of low or intermediate risk myelodysplastic syndrome (MDS) (or high risk patient not eligible to intensive chemotherapy or for bone marrow transplantation), excluding chronic myelomonocytic leukemia
- •At less one of two following conditions:
- •Transfusion dependence: 1)Packed red blood cell transfusions greater than 2 times; 2)Untransfused hemoglobin level no greater than 10 g/dL; 3)Platelet transfusions greater than 1 time
- •Infection grade III or IV secondary to neutropenia
- •ECOG < or = 2
排除标准
- •Chronic myelomonocytic leukemia
- •Creatinine greater than 2 mg/dl
- •Bilirubin greater than 2.5 mg/dl
- •History of heart failure
- •History of allergy to rabbit proteins
结局指标
主要结局
Compare the efficacy and toxicity of antithymocyte globulin and cyclosporine in patients with low risk myelodysplastic syndrome
时间窗: 3 years
次要结局
未报告次要终点
研究者
研究点 (12)
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