NCT00230217已完成4 期
Evaluation of Single Agent Rasburicase in Treatment/Prevention of Hyperuricemia Associated With Tumor Lysis Syndrome in Adult and Pediatric Patients With Lymphoma/Leukemia/Solid Tumor Malignancies at Their First Relapse or Refractory Disease
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 94
- 试验地点
- 14
- 主要终点
- Positive response based on plasma uric acid levels.
研究概览
简要总结
This is an open-label, multi-center study with 2 arms. The primary objective is to assess the response to treatment with rasburicase in 2 populations of adult and pediatric patients with lymphoma/leukemia/solid tumor malignancies, those previously treated with a uricolytic agent, and those not previously treated with a uricolytic agent at their first relapse or refractory disease.
详细描述
This is a multi-center, 2 arm, open-label study;
- Arm A: Patients previously treated with a uricolytic agent;
- Arm B: Patients not previously treated with a uricolytic agent.
Patients receive rasburicase for 5 days and begin chemotherapy 4-24 hours after the first dose of rasburicase. Patients are followed at 14 and 35 days, at 3 and 6 months and every 6 months thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets one of the following risk criteria for tumor lysis syndrome (TLS):
- •A patient is at high risk for TLS if he/she presents with:
- •Hyperuricemia of malignancy (plasma uric acid > 7.5 mg/dL);
- •A diagnosis of a very aggressive lymphoma/leukemia based on the Revised European-American Lymphoma (REAL) classification of lymphoma/leukemia;
- •Acute myeloid leukemia (AML);
- •Chronic myeloid leukemia (CML) in blast crisis; or
- •High grade myelodysplastic syndrome (refractory anemia with excess blast, refractory anemia with excess blast in transformation, or chronic myelomonocytic leukemia) only if they have > 10% bone marrow blast and are given aggressive treatment similar to AML
- •A patient is at potential risk for TLS if he/she presents with:
- •A diagnosis of an aggressive lymphoma/leukemia based on the REAL classification of lymphoma/leukemia plus 1 or more of the following criteria:
- •Lactate dehydrogenase (LDH) > 2 x upper limit of normal (ULN)(IU/L)
- •Stage III-IV disease
- •Stage I-II disease with 1 lymph node/tumor > 5 cm in diameter
- •Patients previously treated with a uricolytic agent or not at their first relapse or refractory disease
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •ECOG equivalent derived from Karnofsky performance scale 100-30 or Lansky performance score 100-30 (patients < or = 16 years of age) may also be used.
- •Life expectancy >3 months
- •Negative pregnancy test (females of child bearing potential) and use of effective contraceptive method (both males and females). A pregnancy test may be performed on serum or urine human chorionic gonadotropin (HCG).
- •Signed written informed consent
排除标准
- •History of established diagnosis of asthma or severe life-threatening atopic allergy
- •Hypersensitivity to uricases or any of the excipients
- •Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency or history of hemolysis indicative of G6PD deficiency
- •Pregnant or lactating
- •Concomitant treatment with any investigational drug
- •Planned treatment with rituximab
- •Receipt of rituximab within the 12 month period prior to study entry
- •Unwilling or unable to comply with the requirements of the protocol
结局指标
主要结局
Positive response based on plasma uric acid levels.
时间窗: up to 48 hours after last administration.
次要结局
- safety assessment
研究者
研究点 (14)
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