Efficacy and safety of TULY (rasburicase) in prevention and treatment of malignancy-associated hyperuricemia - An open-label, multicentre study in India.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 5
- 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 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 1.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of both genders aged between 1 to 75 years; 2.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; 3.Eastern Cooperative Oncology Group (ECOG) performance scale of ≤3; 4.Patients scheduled to receive chemotherapy;.
排除标准
- •1.Patients with allergy or asthma, or hypersensitivity to urate oxidase, or hemolytic reactions;2.Pregnant and lactating;3.Patients with glucose-6-phosphate dehydrogenase deficiency;4.Exposure to rasburicase or allopurinol within 7 days;5.History of psychiatric or co-morbid unstable medical conditions.
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;
2. Plasma uric acid AUC 0-96 hr;
时间窗: At the end of 4 hrs after initiation of uric acid lowering therapy; | During 96 hrs of uric acid lowering therapy;
3. Incidence of adverse events.
时间窗: At the end of 4 hrs after initiation of uric acid lowering therapy; | During 96 hrs of uric acid lowering therapy;
次要结局
- Plasma uric acid AUC0-96 hr(from 0 to 4 days)