An open-label study to evaluate the safety and efficacy of IMATINIB with chemotherapy in pediatric patients with Ph+/BCR-ABL+ acute lymphoblastic leukemia (Ph+ALL) - EsPhA

A.I.E.O.P. - ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA0 个研究点目标入组 550 人开始时间: 2012年12月4日最近更新: 2016年10月24日

适应症

试验速览

暂无简介。

•Children and adolescents aged 1-17 years at diagnosis, with Ph+ALL documented by either cytogenetics , PCR or FISH for bcr-abl, who are eligible for the current local prospective therapeutic study of childhood ALL and for whom informed consent was given by the parents or by legal guardian.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 600
•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) no
•F.1.3.1 Number of subjects for this age range

•1.Abnormal hepatic function (ALAT/ASAT > 10 times the upper limit of the normal range); 2.Abnormal renal function ( creatinine > 1.5 times the upper limit of the normal range or a calculated creatinine clearance of 80ml/ min or less, adjusted to a body surface area of 1.73 sqm); 3.Active systemic bacterial, fungal or viral infection as documented by positive cultures, radiological imaging techniques, septic shock symptoms

发起方

A.I.E.O.P. - ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA