EUCTR2008-006854-17-FR进行中（未招募）1 期
A PROSPECTIVE RANDOMIZED PHASE II STUDY EVALUATING THE OPTIMIZATION OF THE RESIDUAL PLASMATIC LEVEL OF DASATINIB (SPRYCEL®) IN PATIENTS NEWLY DIAGNOSED WITH CHRONIC PHASE CHRONIC MYELOGENOUS LEUKAEMIA (CP-CML). - OPTIM DASATINIB
CH-Versailles0 个研究点目标入组 130 人开始时间: 2009年3月17日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 130
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.ECOG Performance Status score 0-2
- •3.Philadelphia chromosome positive newly diagnosed chronic myelogenous leukaemia (= 3 months) in chronic phase.
- •4.Not previously treated except with hydroxyurea
- •5.Signed written inform consent
- •6.Adequate hepatic function defined as: total bilirubin = 2.0 times the institutional ULN; ALT and AST = 2.5 times the institutional upper limit of normal (ULN).
- •7.Adequate renal function defined as serum creatinine = 3 times the institutional ULN.
- •8.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
- •3.Pregnancy
- •4.Active malignancy
- •5.Uncontrolled or significant cardiovascular disease
- •6.Patients with QTc > 450 ms
- •7.Significant bleeding disorder unrelated to CML
- •8.Concurrent severe diseases which exclude the administration of therapy
研究者
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