EUCTR2009-011675-79-FR进行中（未招募）1 期
A PHASE II STUDY TO ASSESS EFFICACY AND SAFETY OF PIOGLITAZONE (ACTOS®) AS ADD-ON THERAPY TO IMATINIB MESYLATE (GLEEVEC®) IN CHRONIC PHASE CHRONIC MYELOGENOUS LEUKAEMIA (CP-CML) PATIENTS IN MAJOR MOLECULAR RESPONSE (MMR). - ACTIM
CH-Versailles0 个研究点目标入组 50 人开始时间: 2009年4月30日最近更新:
适应症
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
- 50
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.Patient aged 18y or more
- •2.Signed informed consent
- •3.Patient with Philadelphia chromosome positive chronic phase CML and M BCR-ABL transcript positivity
- •4.Treatment with imatinib for more than 2 years
- •5.No dose modification of imatinib within the last 3 months
- •6.Complete cytogenetic response on the last cytogenetic analysis within the last 12 months
- •7.Major molecular remission without complete molecular remission
- •8.ECOG grade 0 to 2
- •9.SGOT et SGPT = 2.5 N
- •10.Bilirubin in serum = 1.5 N
- •11. 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.Pregnant or lactating women,
- •2.Participation in another clinical trial with any investigative drug within 30 days prior to study enrolment,
- •3.Prior history of hématopoietic stem cell transplantation (autologous or allogenic)
- •4.Patient requiring anti-diabetic medication
- •5.Cardiovascular disease:
- •Stage I to IV congestive heart failure (CHF) as determined by the New York Heart Association (NYHA) classification system for heart failure. Note: patients with NYHA
- •Myocardial infarction within the previous 6 months
- •Symptomatic cardiac arrhythmia requiring treatment
- •6.Grade III or IV fluid retention
- •7.Known osteoporosis with therapy
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