NL-OMON33823已完成3 期
Comparative efficacy and safety of two asparaginase preparations in children with previously untreated acute lymphoblastic leukemia (ALL), a phase III clinical trial - MC-ASP.5/A
Medac0 个研究点目标入组 198 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 198
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 17（—）
入选标准
- •Previously untreated T-lineage or percusor B-lineage ALL
- •Morphological proof of ALL (diagnose established by bone marrow morphology with greater than or equal to 25% blasts)
- •Age between 1 year and 19 years
- •Treatment according to DCOG ALL 10 protocol
- •Written informed consent
排除标准
- •Mature B-lineage ALL
- •Patients with secondary ALL
- •Known allergy to any ASNase preparation
- •General health status according to Karnofsky/Lansky score < 40%
- •Pre-existing known coalgulopathy (e.e. haemophilia)
- •Pre-existing pancreatitis
- •Liver insufficiency (bili >50 umol/l, ALAT/ASAT >10xULN)
- •Other current malignancies
- •Pregnacy, breast feeding
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