Febuxostat for Tumor Lysis Syndrome Prevention in Hematologic Malignancies: a Randomized, Double Blind, Phase III Study Versus Allopurinol
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 346
- 主要终点
- Serum Uric Acid (sUA) Level Control
研究概览
简要总结
The purpose of this study is to determine whether febuxostat is superior to allopurinol in the prevention of tumor lysis syndrome (TLS) in patients with hematological malignancies at intermediate or high risk of TLS (according to Cairo-Bishop classification) who undergo chemotherapy
详细描述
This study is designed as a randomised, double-blind, active-controlled, parallel-group study to be conducted in approximately 80 sites.
Approximately 340 male or female patients aged 18 or older suffering from hematologic malignancies (de novo patients or relapsing patients) at intermediate to high risk of TLS and scheduled for receiving the first cycle of cytotoxic chemotherapy, regardless of the line of treatment, will be randomized in this study. Eligible patients (as per screening visit) will be randomly allocated in a 1:1 ratio to Febuxostat or Allopurinol. The double-blind treatment period starts two days prior to the planned beginning of chemotherapy and continues for 7 to 9 consecutive days, according to Investigator judgment and on the basis of the actual duration of chemotherapy regimen administered to the patient. Along the study treatment, uric acid levels, creatinine levels, Laboratory TLS/Clinical TLS and Adverse Events represent the major clinical findings to be monitored on a daily basis. Overall the study encompasses 10 to 11 planned visits at site, including screening, randomisation, on treatment and final follow up visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for first cytotoxic chemotherapy cycle, regardless of the line of treatment, because of hematologic malignancies at intermediate or high risk of TLS (according to the TLS risk stratification, Cairo M et al, British Journal of Haematology, 2010)candidate to Allopurinol treatment or have no access to Rasburicase
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3
- •Life expectancy > 1 month
排除标准
- •Patients known to be hypersensitive to Febuxostat or Allopurinol or to any of the components of the formulations
- •Patients with sUA levels ≥ 10 mg/dL at randomization
- •Patients receiving Febuxostat, Allopurinol or any other urate lowering therapy (e.g. Rasburicase, probenecid) within 30 days prior to randomization
- •Patients with severe renal and/or hepatic insufficiency
- •Patients with diagnosis of LTLS or CTLS at randomization
研究组 & 干预措施
Febuxostat
Febuxostat for 7-9 days
干预措施: Febuxostat (Drug)
Allopurinol
Allopurinol for 7-9 days
干预措施: Allopurinol (Drug)
结局指标
主要结局
Serum Uric Acid (sUA) Level Control
时间窗: 8 days
Area under the curve of sUA from baseline (Day 1) to the evaluation visit (Day 8)
Preservation of Renal Function
时间窗: 8 days
Change in serum creatinine level from baseline (Day 1) to the evaluation visit (Day 8)
次要结局
- Treatment Responder Rate(6 days)
- Assessment of Laboratory Tumor Lysis Syndrome (LTLS)(6 days)
- Assessment of Clinical Tumor Lysis Syndrome (CTLS)(6 days)