CTRI/2013/06/003748已完成2 期
A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (Omacetaxine Mepesuccinate) in the Treatment of Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation
ChemGenex Pharmaceuticals now Teva Pharmaceutical Industries Ltd0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Note: Since there is no upper age limit defined for this trial, for the CTRI registration purpose we have included the upper age limit to be considered as 99 years.
- •Male or female patients, age 18 years or older
- •Philadelphia chromosome (Ph) positive chronic myelogenous leukemia in either chronic, accelerated, or blast phase
- •The patient will have the T315I BCR-ABL gene mutation
- •Patients will have failed prior imatinib therapy
- •ECOG performance status 0-2
- •Bilirubin <= 2.0 times upper limit of normal (ULN), ALT <= 3 times ULN, Creatinine <= 1.5 times
排除标准
- •NYHA class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia and requiring therapy, uncontrolled hypertension or congestive heart failure
- •Myocardial infarction in the previous 12 weeks
- •Lymphoid Ph+ blast crisis
研究者
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