NCT00983138已完成2 期
Efficacy and Safety of Recombinant Asparaginase in Infants (<1 Year) With Previously Untreated Acute Lymphoblastic Leukaemia - Phase II Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- medac GmbH
- 入组人数
- 12
- 试验地点
- 17
- 主要终点
- number of patients with hypersensitivity reactions to rASNase
研究概览
简要总结
This non-controlled multicentre phase II study is designed to assess the safety and to describe (in relation to children of higher age) the pharmacodynamics of recombinant ASNase (rASNase) for first-line treatment of infants (< 1 year of age at diagnosis) with de novo acute lymphoblastic leukaemia
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 364 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated T-lineage or precursor B-lineage ALL or biphenotypic leukaemia according to EGIL criteria.
- •Morphological verification of the diagnosis, confirmed with cyto¬chemistry and immunophenotyping.
- •Age < 1 year at diagnosis.
- •Written informed consent of the parents or other legally authorised guardian of the patient.
- •Treatment according to protocol INTERFANT 06
排除标准
- •Mature B-lineage ALL, defined by the immunophenotypical presence of surface immunoglobulins or t(8;14) and breakpoint as in B-ALL.
- •The presence of the t(9;22)(q34;q11) or bcr-abl fusion in the leukaemic cells.
- •Systemic use of corticosteroids less than 4 weeks before diagnosis. Patients who received corticosteroids by aerosol are eligible.
- •Known allergy to any ASNase preparation.
- •Pre-existing known coagulopathy (e.g. haemophilia).
- •Pre-existing pancreatitis.
- •Liver insufficiency (bilirubin > 50 µmol/L; SGOT/SGPT > 10 x the upper limit of normal).
研究组 & 干预措施
recombinant asparaginase
Experimental
干预措施: recombinant asparaginase (Drug)
结局指标
主要结局
number of patients with hypersensitivity reactions to rASNase
时间窗: within 2 months
次要结局
- pharmacodynamic of rASNase(within 33 days)
研究者
研究点 (17)
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