EUCTR2010-022235-10-DE进行中（未招募）1 期
A Phase I/II study of Azacitidine (Vidaza®) in pediatric patients with newly diagnosed or relapsed high-grade pediatric MDS or JMML - Azacitidine in high grade MDS and JMML pediatric patients
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Erasmus MC
- 入组人数
- 65
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
- •In this study 4 subgroups of patients are eligible, which will be enrolled in 4 different strata:
- •stratum 1: newly diagnosed patients with advanced MDS (RAEB or RAEB-t) in a ‘pre stem cell transplantation window’.
- •stratum 2: relapsed patients with advanced MDS in a ‘re-transplantation window’. At relapse azacitidine may also be continued when a 2nd transplant is not feasible, as long as the patient benefits from treatment.
- •stratum 3: newly diagnosed patients with JMML in a ‘pre-stem cell transplantation window’.
- •stratum 4: relapsed patients with JMML in a ‘re-transplantation window’. Azacitidine may also be continued when a 2nd transplant is not feasible and as long as the patient benefits from treatment.
- •straum 5:newly diagnosed or relapsed patients with secondary advanced MDS, occurring after
- •chemotherapy, radiotherapy and or stem-cell transplantation, or secondary cases after
- •prior treatment for aplastic anemia. Note: secondary MDS cases after bone-marrow failures or familial cases are not eligible
- •General conditions:
- •Advanced primary or secondary MDS or JMML confirmed by the diagnostic criteria as specified in the EWOG-MDS 2006 protocol (see appendix 1)
- •1 month to = 18 years old
- •Lansky play score = 60; or Karnofsky performance status = 60 (appendix 2)
- •Life expectancy = 3 months
- •Normal renal function defined as less than or equal to NCI-CTCAE grade 1 (max 1.5 x ULN).
- •Normal liver function defined as less than or equal to NCI-CTCAE grade 1 (max 2.5 x ULN for transaminases and bilirubin)
- •No chemotherapy within 3 weeks of start of study medication. For 6-MP or low-dose cytarabine in JMML patients 1 week wash-out time is sufficient.
- •For JMML patients: saturation >92% without additional supply of oxygen
- •For JMML patients: peripheral blood monocyte count > 1.0x109/l
- •For relapsed patients following HSCT: recovery of all acute toxic effects of prior chemotherapy/stem-cell transplantation.
- •Able to comply with scheduled follow-up and with management of toxicity.
- •For patients with childbearing potential, a negative test for pregnancy is to be considered before entry on study. If applicable, use of an effective contraceptive method.
- •Written informed consent from patients or from parents or legal guardians for minor patients, according to local law and regulations.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 65
- •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
- •Prior or current history:
- •Other serious illnesses or medical conditions
- •Genetic abnormalities indicative of AML
- •JMML patients in whom a diagnosis of Noonan syndrome is suspected based on clinical history and/or presenting symptoms
- •Patients with secondary MDS with underlying bone-marrow failure syndromes or with familial MDS
- •Isolated extramedullary disease
- •Symptomatic CNS-involvement
- •Current uncontrolled infection
- •Cardiac toxicity (shortening fraction below 28%)
- •Concurrent treatment with any other anti-cancer therapy is not allowed
- •Pregnant or lactating patients
- •Patients who cannot be regularly followed up for psychological, social, familial or geographic reasons
- •Patient with expected non compliance to toxicity management guidelines
- •Prior treatment with a demethylating agent
- •Allergy to azicitidine or mannitol.
研究者
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