NCT00304447已完成4 期
A Phase IV Study of Corticosteroids As Prophylaxis for Infusion-Related Adverse Events to Mylotarg® in Patients With Acute Myelogenous Leukemia (AML)
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 30 人开始时间: 2002年4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
- 30
- 主要终点
- The effect of corticosteroids on the frequency and severity of Mylotarg® infusion-related adverse events.
研究概览
简要总结
The purpose of this study is to evaluate the effect of corticosteroids on the frequency and severity of Mylotarg® infusion-related adverse events, to evaluate the effect of corticosteroids on the efficacy of Mylotarg® induced complete response (CR) and complete response with incomplete platelet recovery (CRp) at one-month post treatment.
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
- 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 with CD33 positive, resistant or relapsed AML.
- •Patients > 18 years of age.
- •ECOG performance status 0-2.
排除标准
- •Fever (>38), chills or hypotension (systolic BP<105mmHg) in the 48 hours preceding therapy.
- •Use of corticosteroids, diphenhydramine or acetaminophen within 24 hours of enrollment.
- •Participation in any other Mylotarg® protocol.
结局指标
主要结局
The effect of corticosteroids on the frequency and severity of Mylotarg® infusion-related adverse events.
次要结局
- The effect of corticosteroids on the efficacy of Mylotarg® induced complete response (CR) and complete response with incomplete platelets recovery (CRp) at one-month post treatment.
研究者
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