A Multi-center, Randomized, Open-label, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Rasburicase (Fasturtec®) in the Prevention and Treatment of Hyperuricemia in Patients With Hematological Malignancies
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Mean plasma uric acid AUC0-96
研究概览
简要总结
Primary:
To compare the efficacy of Rasburicase versus allopurinol in controlling tumor lysis-related hyperuricemia in Chinese patients with leukemia or lymphoma.
Secondary:
To compare the efficacy and safety of Rasburicase versus allopurinol in Chinese patients stratified according to disease (leukemia or lymphoma ).
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At high risk of malignancy and/or chemotherapy-induced hyperuricemia
- •Performance status less than 3 on ECOG scale or more than 30% KPS scale
- •Uric acid concentrations ≥ 8.0mg/dL
- •Suffering from non-Hodgkin's lymphoma Stage more than III, or acute lymphoblastic leukemia with peripheral with blood cell count more than 25,000/mm3, or any lymphoma or leukemia
排除标准
- •Treatment with an investigational drug at any time during the 14-day study period (except for agents that are permitted by the Sponsor)
- •Pregnancy or lactation
- •Prior treatment with Uricozyme or Rasburicase
- •Scheduled to receive asparaginase either 24 hours after the first dose of rasburicase
- •Treatment with Allopurinol within the seven days preceding study Day 1
- •History of significant atopic allergy problems or documented history of asthma
- •History of severe reaction to allopurinol
- •Known history of glucose-6-phosphate dehydrogenase deficiency.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
IV infusion at a dose level of 0.20mg/kg per day
干预措施: Rasburicase (Drug)
2
100mg tablets, administered orally, according to standard medical practice
干预措施: Allopurinol (Drug)
结局指标
主要结局
Mean plasma uric acid AUC0-96
时间窗: 0hour, 4hour, 12 hour and q12h thereafter
Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL (only in patients hyperuricemic immediately prior to dosing)
时间窗: From administration of drug up to end of study
Biochemistry, hematology, vital signs, physical examination, and adverse events
时间窗: From administration of drug up to end of study
Proportion of patients developing hypertension requiring therapy
时间窗: From administration of drug up to end of study
Assays for circulating antibodies
时间窗: From administration of drug up to end of study
次要结局
- Percentage reduction of plasma uric acid concentrations at T4h(From administration of drug up to end of study)
- Mean plasma uric acid concentrations(At various timepoints)
- Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL(From administration of drug up to end of study)