2024-518669-83-00招募中2 期
ICC APL STUDY 02 Treatment study for children and adolescents with Acute Promyelocytic Leukemia
Associazione Italiana Ematologia Oncologia Pediatrica61 个研究点 分布在 4 个国家目标入组 99 人开始时间: 2019年10月19日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 99
- 试验地点
- 61
研究概览
简要总结
To assess, in an international pediatric study, the efficacy, in terms of event-free survival, of a combination of ATO and ATRA in newly diagnosed SR APL children and adolescents and to explore the safety and efficacy of a combination therapy comprising ATRA/ATO + GO in HR APL.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed APL confirmed by the presence of PML/RARα fusion gene
- •Age <18 years
- •Written informed consent by parents or legal guardians
- •If applicable, female participants must have a negative pregnancy test by beta-HCG dosing.
- •Patients of child-bearing or child-fathering potential must be willing to adapt their own conduct so as not to procreate during the study participation and must contact their physician to identify the most appropriate approach strategy for this purpose starting from the time of enrolment and for 3 months after receiving the last drug dose
排除标准
- •Patients with a clinical diagnosis of APL but subsequently found to lack PML/RARα rearrangement should be withdrawn from the study and treated on an alternative protocol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, ECG abnormalities (ECG abnormalities: Congenital long QT syndrome; History or presence of significant ventricular or atrial tachyarrhythmia; Clinically significant resting bradycardia (<50 beats per minute); QTc >450 msec documented during screening EKG), other cardiac contraindications (L-FEV <50% or LV-FS <28%)
- •Concurrent active malignancy
- •Uncontrolled life-threatening infections
- •Pregnant or lactating female
- •Patients who had received alternative therapy (APL not initially suspected; ATRA and/or ATO not available)
研究者
Arcangelo Prete
Scientific
Associazione Italiana Ematologia Oncologia Pediatrica
研究点 (61)
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