EUCTR2008-001107-27-DE进行中（未招募）不适用
PHASE I-II MULTICENTER STUDY OF P210-B2A2 DERIVED PEPTIDE VACCINE IN CHRONIC MYELOID LEUKEMIA PATIENTS IN COMPLETE CYTOGENETIC RESPONSE WITH PERSISTENT MOLECULAR RESIDUAL DISEASE DURING IMATINIB TREATMENT
niversität Leipzig0 个研究点目标入组 48 人开始时间: 2009年12月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
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
- •-Age = 18 years
- •-Diagnosis of CML with b2a2 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).
- •-ECOG performance score of 0 or 1
- •-Total bilirubin = 2x upper limit of normal
- •-AST and ALT = 2.5x upper limit of normal
- •-Creatinine = 1.5x upper limit of normal
- •-Adequate cardiac function
- •-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
研究者
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