TREATMENT STUDY FOR CHILDREN AND ADOLESCENTS WITH ACUTE PROMYELOCYTIC LEUKEMIA - ICC APL STUDY 01

A.I.E.O.P. - ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA0 个研究点目标入组 300 人开始时间: 2009年3月10日最近更新: 2012年3月19日

试验速览

暂无简介。

•- Patients with a clinical diagnosis of initial APL and subsequently confirmed to have PML-RARα, NPM1-RARα or NUMA-RARα fusion. - Less than 21 years of age at initial diagnosis (less than 18 years for italian centers) - Considered suitable for anthracycline-based chemotherapy - Written informed consent available - Females of childbearing age must have a negative pregnancy test and subsequently must attempt to avoid pregnancy
•Are the trial subjects under 18? yes
•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

•- Patients with a clinical diagnosis of APL but subsequently found to have PLZF-RARα fusion or lacking PML-RAR, NPM-RAR or NuMA-RAR rearrangement should be withdrawn from the study and treated on an alternative protocol. - Refractory/relapsed APL (the guidelines in this protocol for that subgroup are intended for patients treated from initial diagnosis according to this protocol) - Concurrent active malignancy - Pregnant or lactating - Physician and patient/guardian think that intensive chemotherapy is not an appropriate treatment option - Patients who have received alternative chemotherapy for 7 days or longer without ATRA for any reason (either APL not initially suspected or ATRA not available).

发起方

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