EUCTR2010-022235-10-ES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
适应症
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
- 5
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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