EUCTR2006-006189-40-IT进行中（未招募）不适用
PHASE II MULTICENTER STUDY OF P210-B3A2 DERIVED PEPTIDE VACCINE IN CHRONIC MYELOID LEUKEMIA PATIENTS IN COMPLETE CYTOGENETIC RESPONSE WITH PERSISTENT MOLECULAR RESIDUAL DISEASE DURING IMATINIB TREATMENT - GIMEMA CML0206
G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL ADULTO0 个研究点目标入组 69 人开始时间: 2007年4月4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
- 入组人数
- 69
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
- •- Diagnosis of CML with b3a2 breakpoint - Conventional treatment with imatinib for a minimum of 18 months - Complete cytogenetic response documented al least in 2 different examinations - Persistence of molecularly detectable residual disease any level of bcr-abl transcript . - WHO performance score of 0 or 1 - Total bilirubin 8804; 2x upper limit of normal - AST and ALT 8804; 2.5x upper limit of normal - Creatinine 8804; 1.5x upper limit of normal - Female patients of childbearing potential must agree to use contraception during the study - Provide written informed consent
- •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
- •- Severe active infection or other serious medical illness that would prevent study completion - Current use of immune suppression or systemic immunosuppressive medication or autoimmune disorders - Patients who have a known immunodeficiency - Current use of investigational products - Pregnant or lactating women - Patients who cannot provide or are not willing to provide an informed consent
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