NCT00037596已完成2 期
A Dose Ranging Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) Given in Combination With Cytarabine in Relapsed or Refractory Patients and Alder De Novo Patients With Acute Myeloid Leukemia.
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点开始时间: 2000年8月1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
研究概览
简要总结
The primary objectives are a) to establish the maximum tolerated dose of gemtuzumab ozogamicin in combination with cytarabine and b) to assess the safety of gemtuzumab ozogamicin when given concurrently with cytarabine.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Morphologic diagnosis of AML from bone marrow aspirate and biopsy
- •Flow cytometry, performed at the study site, must demonstrate that the patient has AML that is CD33+, based on local laboratory criteria
- •Age 18 years or older for relapsed or refractory patients for Phase I of this study
排除标准
- •Patients with de novo AML of the M3 subtype
- •AML following an antecedent hematologic disorder (myelodysplasia or myeloproliferation) of > 2 months duration
- •AML secondary to exposure to chemotherapy or radiation
研究者
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