EUCTR2004-004321-95-AT进行中（未招募）1 期
RANDOMIZED PHASE II-STUDY ON VALPROIC ACID, ALL-TRANS RETINOIC ACID AND THEIR COMBINATION IN INDUCTION AND CONSOLIDATION THERAPY AS WELL AS PEGFILGRASTIM AFTER CONSOLIDATION THERAPY IN YOUNGER PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA
niversity of Ulm0 个研究点目标入组 304 人开始时间: 2005年4月21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
- 304
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.) Newly diagnosed AML defined according the WHO-classification (excluding APL)
- •2.) Age 18-60 years
- •3.) All patients have to be informed about the character of the study. Written informed consent of each patient at study entry
- •4.) Molecular and cytogenetical diagnostics on initial bone marrow and peripheral blood specimen have to be performed at the central reference laboratories
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.) Bleeding independent of the AML
- •2.) Acute promyelocytic leukemia
- •3.) Uncontrolled infection
- •4.) Participation in a concurrent clinical study
- •5.) Insufficiency of the kidneys (Crea >1.5x upper normal serum level), of the liver (bilirubine, AST or AP > 2x upper normal serum level), severe obstructive or restrictive ventilation disorder, heart failure NYHA III/IV
- •6.) Severe neurological or psychiatric disorder interfering with ability of giving an informed consent
- •7.) No consent for the registration, storage and processing of data concerning the characteristics of the AML and the individual course
- •8.) Performance status WHO > 2
- •9.) Pregnancy
研究者
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