EUCTR2015-004625-14-IT进行中（未招募）1 期
Open-label, dose-escalating trial to evaluate the tolerability, toxicity, safety, pharmacokinetics, pharmacodynamics and activity of volasertib added to the standard intensive salvage chemotherapy regimen with liposomal daunorubicine, fludarabine and cytarabine (DNX-FLA) followed by fludarabine and cytarabine (FLA) in children from 3 months to less than 18 years of age with acute myeloid leukaemia after failure of the front-line therapy
Boehringer Ingelheim Italia S.p.A.0 个研究点目标入组 52 人开始时间: 2016年8月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 52
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
- •- Patients 3 months to <18 years of age at the time of informed consent
- •- Patients with AML after failure of the front-line intensive AML therapy
- •- Lansky score at screening =50 for patients from 3 months to <12 years
- •- Karnofsky score at screening =50 for patients from 12 to <18 years
- •- Use of highly effective methods of birth-control, if sexually active
- •- Parents/legal guardians and patients have given written informed consent and informed assent suitable for the respective age group
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 42
- •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
- •- Down syndrome
- •- Acute promyelocytic leukaemia and treatment-related AML
- •- QTc prolongation
- •- LVSF <30%
- •- Cardiac disease and/or dysfunction
- •- Active uncontrolled infection
- •- HIV infection, acute or chronic hepatitis
- •- Inadequate lab parameters
- •- Impaired renal function
- •- Pregnancy or nursing
研究者
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