CTRI/2012/10/003050已完成不适用
To compare the role of hydroxyurea and hyperhydration versus hyperhydration alone to decrease total leukocyte count in children of acute leukemia with hyperleukocytosis: a randomized control trial.
No primary sponcer1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2012年7月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- To demonstrate that addition of hydroxyurea to conventional management causes a significant decline in TLC (fall in TLC 50% of baseline TLC in 72 hours) in a greater number of patients as compared to conventional therapy alone in newly diagnosed children (1-12 years) with acute leukemia and hyperleukocytosis.
研究概览
简要总结
Trial is on basis of drug hydroxyuria which is used in many center for hyperleukocytosis & previous non randomized trial also shown efficacy. This trial will add in determining role of hydroxyuria in hyperleukocytosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢New case of acute leukemia with hyperleukocytosis •Parent consent for trial •Parent willing to take treatment for their child in our centre.
排除标准
- •â€¢Refusal of consent •Relapse of disease •Age less then 1 year or more then 12 year •Case treated outside •Hyperleukocytosis associated with disease other than acute leukemia •Hyperleukocytosis presented with acute renal failure, intracranial bleed and requiring ventilation.
结局指标
主要结局
To demonstrate that addition of hydroxyurea to conventional management causes a significant decline in TLC (fall in TLC 50% of baseline TLC in 72 hours) in a greater number of patients as compared to conventional therapy alone in newly diagnosed children (1-12 years) with acute leukemia and hyperleukocytosis.
时间窗: 72 hours
次要结局
- 1.To document reduction in complications associated with hyperleukocytosis with addition of hydroxyurea to conventional treatment.(•Tumor lysis)
研究者
研究点 (1)
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