A Randomized Study to Evaluate the Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia in Elderly Patients (QoLESS AZA-AMLE) - QoLESS-AZA-AMLE

ASSOCIAZIONE QOL-ONE0 个研究点目标入组 95 人开始时间: 2010年6月21日最近更新: 2022年1月17日

适应症

试验速览

暂无简介。

•1. Age 61 years or more 2. Newly diagnosed AML with > 30% myeloid marrow blasts, either ``de novo`` or evolving from a MDS not previously treated with chemotherapeutic agents. 3. Absence of central nervous system involvement 4. No contraindications for intensive chemotherapy, defined as: a) prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range; b) a creatinine or bilirubin level more than twice the upper limit of normal, except if AML-related; c) a PS score of > 2; d) uncontrolled severe infection. 5. Informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•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. Age = 60 years 2. Newly diagnosed AML with < 30% myeloid marrow blasts 3. Previously treated AML 4. Central nervous system involvement 5. Prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range; 6. A creatinine or bilirubin level more than twice the upper limit of normal, except if AML-related; 7. A PS score of > 2; 8. Uncontrolled severe infection

发起方

ASSOCIAZIONE QOL-ONE