RANDOMIZED PHASE III-STUDY ON VALPROIC ACID IN COMBINATION WITH ALL-TRANS RETINOIC ACID, STANDARD INDUCTION- AND CONSOLIDATION THERAPY IN OLDER PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA

niversitätsklinikum Ulm / University Clinical Center Ulm0 个研究点目标入组 500 人开始时间: 2005年7月25日最近更新: 2021年7月12日

适应症

试验速览

暂无简介。

•1.) Newly diagnosed AML defined according the WHO-classification (excluding APL)
•2.) Age >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) yes
•F.1.3.1 Number of subjects for this age range

•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

发起方

niversitätsklinikum Ulm / University Clinical Center Ulm