NCT00037583已完成2 期
A Dose-Ranging Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (go) Given in Combination With Cytarabine and Daunorubicin in Relapsed or Refractory Patients and in Younger de Novo Patients With Acute Myeloid Leukemia (AML)
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 69 人开始时间: 2002年5月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 69
研究概览
简要总结
The primary objectives are a) to establish the maximum tolerated dose (MTD) of gemtuzumab ozogamicin in combination with cytarabine and daunorubicin, and b) to assess the safety of gemtuzumab ozogamicin when given concurrently with cytarabine and daunorubicin.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients with relapsed or refractory AML, as well as younger de novo AML patients are eligible for the study
- •Relapsed, refractory, and de novo AML patients are allowed in Phase I of this study
- •Phase II will only allow enrollment of younger de novo AML
排除标准
- •AML following an antecedent hematologic disorder (myelodysplasia or myeloproliferation) of greater than 2 months duration
- •De novo patients with M3 AML
- •AML secondary to exposure to chemotherapy or radiation
研究者
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