Evaluation of Single Agent Rasburicase for 5 Days Versus Sequential Treatment With Rasburicase From Day 1 Through 3 Followed by Oral Allopurinol From Day 3 Through 5 (Overlap on Day 3) Versus Single Agent Oral Allopurinol for 5 Days in the Management of Plasma Uric Acid in Adult Patients With Leukemia, Lymphoma, and Solid Tumor Malignancies at Risk for Hyperuricemia and Tumor Lysis Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 280
- 试验地点
- 15
- 主要终点
- Plasma Uric Acid Responder
研究概览
简要总结
This is a randomized, multi-center, open-label, parallel group study with three arms:
- Rasburicase alone
- Rasburicase followed by Allopurinol
- Allopurinol alone
The primary objective is to compare the adequacy of control of plasma uric acid concentration and the safety profile among the three arms.
详细描述
After signing the informed consent and having met the inclusion criteria, patients will be randomized to 1 of the 3 arms and treated for a total duration of 5 days. Patients in all arms will receive chemotherapy beginning 4-24 hours after the first dose of rasburicase or allopurinol.
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
- None
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
- •Meets high risk or at potential risk 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 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, chronic myelomonocytic leukemia, and refractory anemia with excess blast in transformation) only if they have > 10% bone marrow blast involvement and are given aggressive treatment similar to AML.
- •A patient is at potential risk for TLS if he/she presents with:
- •A diagnosis of 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 at least 1 lymph node/tumor > 5 cm in diameter
- •In addition to the above-mentioned eligibility criteria, the patients should have the following criteria:
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-3
- •Age >= 18 years
- •Life expectancy > 3 months
- •Negative pregnancy test (females of child bearing potential) and use of effective contraceptive method (for 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
- 未提供
研究组 & 干预措施
Arm B
Rasburicase alone given as a single agent from Day 1 through Day 3, followed by oral allopurinol given from Day 3 through Day 5 (Day 3 is an overlap)
干预措施: Rasburicase (SR29142) (Drug)
Arm A
Rasburicase alone given as a single agent for 5 days
干预措施: Rasburicase (SR29142) (Drug)
Arm B
Rasburicase alone given as a single agent from Day 1 through Day 3, followed by oral allopurinol given from Day 3 through Day 5 (Day 3 is an overlap)
干预措施: Allopurinol (Drug)
Arm C
Oral allopurinol alone given as a single agent for 5 days
干预措施: Allopurinol (Drug)
结局指标
主要结局
Plasma Uric Acid Responder
时间窗: Day 3 through Day 7
Number of patients responding to treatment defined as plasma uric acid levels at Day 3 through Day 7 \<7.5 mg/dl.
次要结局
- Time to Uric Acid Control(Day 1 to Day 7)
- Plasma Uric Acid(Day 1 to Day 7)