EUCTR2010-019568-35-FR进行中（未招募）不适用
A prospective randomized phase II study evaluating the monitoring of imatinib mesylate (Gliveec®) plasmatic through level in patients newly diagnosed with chronic phase chronic myelogenous leukaemia (CP-CML). - OPTIM IMATINIB
CH VERSAILLES0 个研究点开始时间: 2010年5月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or female patient = 18 years
- •2.Philadelphia chromosome positive newly diagnosed chronic myelogenous leukaemia (= 4 months) in first chronic phase.
- •3.Not previously treated with tyrosine kinase inhibitors other than imatinib
- •4.Prior treatment with imatinib during less than 6 weeks
- •5.Signed written inform consent
- •6.Women of childbearing potential (WOCBP) must be using an adequate method of contraception
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patients with BCR-ABL positive, Philadelphia negative CML
- •2.Patient previously treated with TKI other than imatinib
- •3.Pregnancy
- •4.Active malignancy
- •5.Concurrent severe diseases which exclude the administration of therapy
研究者
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