NCT00199043已完成3 期
Randomised Phase III Trial of Effectivity and Safety of Rasburicase Compared With Allopurinol for Treatment of Hyperuricemia in Patients With Acute Lymphoblastic Leukemia or High-Grade NHL With High Risk of Tumorlysis Syndrome (> 15 Yrs)
Goethe University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2003年5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
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- renal function, uric acid, electrolytes, adverse events and mortality in pre-phase and the two following cycles of chemotherapy, time and dose compliance of chemotherapy
研究概览
简要总结
In this study the efficacy and tolerability of two approaches to treat and prevent hyperuricemia is tested in patients with acute lymphoblastic leukemia or high-grade lymphoma with high risk of tumor lysis syndrome. Both arms are compared by randomisation. In one arm patients receive during pre-phase chemotherapy conventional prophylaxis with allopurinol whereas in the other arm Rasburicase is used.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients of the GMALL B-ALL/NHL-Study 2002
- •patients of the GMALL-Study 07/2003
- •patients of the GMALL-Study Elderly 1/2003 which fulfill the following criteria:
- •bulky disease (> 7.5 cm)
- •high LDH (> 2 x UNL)
- •uric acid >8 mg/dl/ >475µmol/L at diagnosis
- •leukocytes > 30 000/µl
排除标准
- •exclusion Criteria of the GMALL B-ALL/NHL Study 2002 or the GMALL-Study 07/2003 or GMALL-Elderly 1/2003 and:
- •asthma or severe, live-threatening atopic allergy in history
- •hypersensitivity against Uric acid
- •Glucose-6-Phosphate-Dehydrogenase deficiency
- •pretreatment with Rasburicase or Urikozyme™
研究组 & 干预措施
Only 1 arm
Experimental
干预措施: Allopurinol (Drug)
Only 1 arm
Experimental
干预措施: Rasburicase (Drug)
结局指标
主要结局
renal function, uric acid, electrolytes, adverse events and mortality in pre-phase and the two following cycles of chemotherapy, time and dose compliance of chemotherapy
时间窗: 3 weeks
after cycle 1
次要结局
- response rate, incidence of tumor lysis syndrome(3 weeks)
研究者
Nicola Goekbuget
Study Coordinator
Goethe University
研究点 (1)
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