NL-OMON33689已完成2 期
Efficacy and safety of recombinant asparaginase in infants ( < 1 year) with previously untreated acute lymphoblastic leukemia, a phase II clinical trial - Efficacy and safety of r-asp in infants with previously untreated A
Medac0 个研究点目标入组 6 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 11（—）
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 cytochemistry and immunophenotyping. In case a bone marrow aspiration results in a *dry tap*, a trephine biopsy is advised unless it is possible to confirm the diagnosis by peripheral blood examination.
- •- Age < 1 year at diagnosis
- •- Written informed consent of the parents or other legally authorised guardians of the patient
- •- Treatment according to protocol INTERFANT 06 (EudraCT Number 2005-004599-19)
排除标准
- •- Mature B-lineage ALL
- •-The presence of the t(9;22)(q34;q11) or bcr-abl fusion in the leukaemic cells (if these data are not known, the patient is eligible)
- •- 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).
研究者
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