NCT00784017已完成3 期
Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- medac GmbH
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- To determine the rate of patients with complete asparagine (ASN) depletion in serum during induction treatment and to demonstrate non-inferiority of rASNase compared to Asparaginase medac™ with respect to this parameter
研究概览
简要总结
This multicentric phase III study is designed to assess the efficacy and safety of recombinant asparaginase (rASNase) in comparison to Asparaginase medac™ during treatment of children with de novo ALL
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated T-lineage or precursor B-lineage ALL
- •Patients must have morphological proof of ALL and diagnosis must be made from bone marrow morphology with more than 25% blasts
- •Written informed consent
- •Treatment according to DCOG ALL 10 protocol
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 coagulopathy (e.g. haemophilia)
- •Pre-existing pancreatitis
- •Liver insufficiency (Bilirubin > 50 µmol/L; SGOT/SGPT > 10 x ULN)
- •Other current malignancies
- •Pregnancy (planned or existent), breast feeding
研究组 & 干预措施
asparaginase medac
Active Comparator
干预措施: asparaginase (Drug)
recombinant asparaginase
Experimental
干预措施: recombinant asparaginase (Drug)
结局指标
主要结局
To determine the rate of patients with complete asparagine (ASN) depletion in serum during induction treatment and to demonstrate non-inferiority of rASNase compared to Asparaginase medac™ with respect to this parameter
时间窗: March 2012
次要结局
- To assess the incidence of patients with hypersensitivity reactions to the first dose of ASNase in the post-induction treatment(March 2012)
研究者
研究点 (1)
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相似试验
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Comparative efficacy and safety of two asparaginase preparations in children with previously untreated acute lymphoblastic leukemia (ALL), a phase III clinical trialacute lymphoblastic leukemia in children10024324NL-OMON33823Medac198
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不适用
Comparative efficacy and safety of two asparaginase preparations in children with previously untreated acute lymphoblastic leukaemia - Comparative efficacy and safety of two asparaginase preparations in children with de novo AAcute lymphoblastic leukaemia (ALL) is a clonal disease resulting from genetic mutations and transformation of a single early progenitor lymphoid cell. Uncontrolled expansion of leukaemic blasts in the bone marrow leads to suppression of normal haematopoiesis as well as disseminated infiltration of organs and release of blasts into periphal blood.MedDRA version: 9.1Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaEUCTR2006-003180-31-NLmedac GmbH
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