Efficacy and Safety of TULY in Prevention and Treatment of Malignancy-associated Hyperuricemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percentage of reduction in plasma uric acid at 4 hrs after uric acid-lowering therapy
研究概览
简要总结
This study is a prospective, open-label, multicentre study. Hundred eligible patients with stage III or IV non-Hodgkin lymphoma (NHL) or acute lymphoblastic leukemia (ALL) with a peripheral white blood cell (WBC) count of > 25,000/µL or any leukemia or lymphoma with plasma uric acid level of at least 8 mg/dL will be treated with rasburicase 0.20 mg/kg body weight intravenously for 4 days. The primary endpoints viz., the percentage of reduction in plasma uric acid at 4 hrs after uric acid-lowering therapy, plasma uric acid AUC 0-96 hr and incidence of adverse events will be assessed during 11 days study period.
详细描述
All eligible patients will be treated with rasburicase 0.20 mg/kg body weight intravenously for 4 days. The primary endpoints viz., the percentage of reduction in plasma uric acid at 4 hrs after uric acid-lowering therapy, plasma uric acid AUC 0-96 hr and incidence of adverse events will be assessed during 11 days study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both genders aged between 1 to 75 years;
- •Patients with stage III or IV non-Hodgkin lymphoma (NHL) or acute lymphoblastic leukemia (ALL) with a peripheral WBC count of >25,000/µL or any leukemia or lymphoma with plasma uric acid level of at least 8 mg/dL;
- •Eastern Cooperative Oncology Group (ECOG) performance scale of ≤3;
- •Patients scheduled to receive chemotherapy.
排除标准
- •Patients with allergy or asthma, or hypersensitivity to urate oxidase, or hemolytic reactions;
- •Pregnant and lactating;
- •Patients with glucose-6-phosphate dehydrogenase deficiency;
- •Exposure to rasburicase or allopurinol within 7 days;
- •History of psychiatric or co-morbid unstable medical conditions
研究组 & 干预措施
Tuly, uric acid lowering drug
TULY (rasburicase) 0.20 mg/kg body weight intravenously for 4 days
干预措施: TULY (Drug)
结局指标
主要结局
Percentage of reduction in plasma uric acid at 4 hrs after uric acid-lowering therapy
时间窗: At the end of 4 hrs after initiation of uric acid lowering therapy; during 96 hrs of uric acid lowering therapy; Adverse events during the entire study period
次要结局
- Incidence of adverse events(At the end of 4 hrs after initiation of uric acid lowering therapy; during 96 hrs of uric acid lowering therapy; Adverse events during the entire study period)
- Plasma uric acid AUC 0-96 hr(At the end of 4 hrs after initiation of uric acid lowering therapy; during 96 hrs of uric acid lowering therapy; Adverse events during the entire study period)