EUCTR2017-002383-40-IT进行中（未招募）1 期
Treatment study for children and adolescents with Acute Promyelocytic Leukemia - ICC APL Study 02
AIEOP- Associazione Italiana Ematologia Oncologia Pediatrica0 个研究点目标入组 90 人开始时间: 2018年10月15日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Newly diagnosed APL confirmed by the presence of PML/RARa fusion gene
- •- Age <18 years
- •- Written informed consent by parents or legal guardians
- •- WBC at diagnosis =10 x 109/L
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 90
- •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
排除标准
- •Patients with a clinical diagnosis of APL but subsequently found to lack PML/RARa rearrangement should be withdrawn from the study and treated with an alternative protocol
- •- Significant liver dysfunction (bilirubin serum levels >3 mg/dL, ALT/AST serum levels greater than 5 times the normal values)
- •- Creatinine serum levels >2 times the normal value for age
- •- Significant arrhythmias, EKG abnormalities (*see below), other cardiac contraindications (L-FEV < 50% or LV-FS <28%)
- •- Neuropathy grade 2 or greater
- •- Concurrent active malignancy
- •- Uncontrolled life-threatening infections
- •- Pregnant or lactating females
- •- Patients who had received alternative therapy (APL not initially suspected; ATRA and/or ATO not available)
研究者
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不适用
TREATMENT STUDY FOR CHILDREN AND ADOLESCENTS WITH ACUTE PROMYELOCYTIC LEUKEMIA - ICC APL STUDY 01EUCTR2008-002311-40-ITA.I.E.O.P. - ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA300