NCT00991744暂停3 期
Phase III Randomised Study on Liposomal Cytarabine (DepoCyte®) vs. Intrathecal Triple for CNS-Treatment During Maintenance Therapy in High-Risk Acute Lymphoblastic Leukemia Patients in NOPHO ALL 2008 Treatment Protocol
Nordic Society for Pediatric Hematology and Oncology5 个研究点 分布在 5 个国家目标入组 100 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Number of leukemia relapses in the central nervous system
研究概览
简要总结
- Replacement of intrathecal Triple (methotrexate, cytarabine, prednisolone) with intrathecal liposomal cytarabine and prednisolone during maintenance therapy will decrease the CNS relapse rate in high-risk ALL patients.
- Both acute and long-term toxicity are equal in both treatment arms.
详细描述
20% of children with ALL still fails to be cured. The ALL-2008 protocol is a treatment and research protocol that aims to improve the overall outcome of Nordic children and adolescents with ALL in comparison with the ALL-2000 protocol and previous NOPHO protocols.
The specific and primary objectives of the randomised study is:
- To replace intrathecal triple (methotrexate, cytarabine and glucocorticosteroid) by intrathecal liposomal cytarabine and glucocorticosteroid during maintenance therapy in order to decrease the central nervous system relapse rate in high-risk acute lymphoblastic leukemia patients.
- To evaluate acute and long-term toxicity in both treatment arms.
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
- None
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
- •High risk acute lymphoblastic leukemia
- •Not eligible for bone marrow transplantation
- •Written informed consent has been obtained
排除标准
- •Persistent NCI grade 3-4 neurotoxicity from previous treatments
- •Bilineage ALL
- •Leukemia predisposing syndromes (e.g. Downs syndrome, Ataxia Telangiectasia)
- •Previous cancer
- •Known intolerance to NOPHO ALL 2008 anticancer agents
- •Sexually active females will use safe contraceptives
- •Previous treatment with intrathecal liposomal cytarabine
研究组 & 干预措施
Liposomal cytarabine
Experimental
Intrathecal liposomal cytarabine (25 - 50 mg) combined with intrathecal prednisolone sodium succinate and oral dexamethasone 6 times during maintenance treatment for high-risk ALL
干预措施: Liposomal cytarabine (Drug)
Intrathecal triple
Active Comparator
Intrathecal methotrexate, cytarabine and prednisolone
干预措施: Intrathecal triple (Drug)
结局指标
主要结局
Number of leukemia relapses in the central nervous system
时间窗: 5 years
次要结局
- Neurological toxicity(6 months after cessation of leukemia therapy)
研究者
Arja Harila-Saari
Associate professor
Nordic Society for Pediatric Hematology and Oncology
研究点 (5)
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