INDUCTION, CONSOLIDATION AND INTENSIFICATION PROTOCOL FOR PATIENTS YOUNGER THAN 66 YEARS WITH PREVIOUSLY UNTREATED CD33 POSITIVE ACUTE MYELOID LEUKEMIA (AML) - ND

AZIENDA OSPEDALIERA S. MARIA DELLA MISERICORDIA0 个研究点开始时间: 2008年4月23日最近更新: 2016年5月17日

适应症

试验速览

暂无简介。

•Age 18-65 years. WHO PS grade 0-2 or Karnofsky > 70. AML according to the new WHO criteria, i.e. % of BM blasts ≥ 20%. All FAB subtypes except M3. CD33 positivity (> 20%). It is mandatory to perform an immunothyping of the BM blasts in particular the determination of CD33 positivity, which will be used as a inclusion factor. Previously untreated (except ≤ 14 days of Hydroxyurea) primary or secondary AML (including AML after MDS). Adequate renal and liver function, i.e. creatinine < 2 mg/dl and bilirubin, ALT/AST ≤ 3 times the upper limit of normal.
•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

•Blast crisis of chronic myeloid leukemia. AML supervening after other myeloproliferative diseases. AML de novo or secondary previously pretreated. Concomitant malignant disease. Active central nervous system (CNS) leukemia. Active uncontrolled infection [NB severe systemic infection should be excluded]. Concomitant severe cardiovascular disease, i.e. arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease. Cardiac ejection fraction of 50% or less. Severe pulmonary dysfunction (CTC grade 3-4). Severe concomitant neurological or psychiatric disease. History of alcohol abuse. HIV positivity. Pregnancy.

发起方

AZIENDA OSPEDALIERA S. MARIA DELLA MISERICORDIA