ACTRN12609000373279已完成2 期
A multi-center phase II open-label study to evaluate the efficacy and safety of subcutaneous administration of omacetaxine in the treatment of patients with chronic myeloid leukemia (CML) in chronic, accelerated and blast phase who have tested positive for the T315I bcr-abl point mutation.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Male or female patients, age 18 years or older.
- •2. Philadelphia chromosome (Ph) positive chronic myelogenous leukemia in either chronic, accelerated, or blast phase.
- •3. The patient will have the T315I BCR-ABL gene mutation.
- •4. Patients will have failed prior imatinib therapy.
- •5. Acceptable Renal and Liver Function.
- •6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- •7. Sexually active patients and their partners must use an effective double barrier method of contraception.
排除标准
- •1. New York Heart Association (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.
- •2. Lymphoid Ph+ blast crisis.
- •3. Pregnant or lactating.
- •4. Any medical or psychiatric condition, which may compromise the ability to give written informed consent or to comply with the study protocol.
- •5. Patient is candidate (and has a donor identified) for bone marrow or blood stem cell transplantation.
- •6. Patient is enrolled in another clinical investigation within 30 days of enrollment or is receiving another investigational agent.
研究者
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