Efficacy and Safety of Two Comparable Single Low Doses of Rasburicase Followed by Allopurinol in Adult Patients With Malignancy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Probability of Obtaining a Uric Acid Level =< 7.5mg/dL
研究概览
简要总结
This randomized phase II trial studies how well giving rasburicase together with allopurinol works in treating patients with hematologic malignancies. Rasburicase may reduce the level of uric acid in the blood. Allopurinol may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known which dose of rasburicase is more effective in treating hematologic malignancies when given together with or without allopurinol.
详细描述
PRIMARY OBJECTIVES:
I. To prospectively evaluate the efficacy, as defined by uric acid response rate, of 2 different single low doses of rasburicase followed by allopurinol in 2 treatment arms.
SECONDARY OBJECTIVES:
I. To estimate the proportion of patients requiring additional doses of rasburicase to maintain a uric acid level =< 7.5mg/dL on day 2 through day 6.
II. To identify differential characteristics of the patients who do not respond to treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) status of 0-3
- •Active leukemia and Burkitt leukemia/lymphoma treated in-house that puts them at risk for tumor lysis syndrome (TLS)
- •Serum uric acid level >= 7.5mg/dL and high risk for TLS as defined by:
- •A diagnosis of acute myeloid leukemia (AML), or
- •A diagnosis of blast-phase chronic myeloid leukemia (CML), or
- •A diagnosis of high-grade myelodysplastic syndrome (MDS) with >= 10% blast bone marrow blast involvement, or
- •Acute lymphoblastic leukemia (ALL), or
- •Burkitt leukemia/lymphoma
- •Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
排除标准
- •History of asthma
- •History of severe or life threatening atopic allergy
- •Hypersensitivity to uricases
- •Known prior sensitivity to allopurinol
- •Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •Recent prior history of uricolytic therapy defined as therapy within the last 7 days
研究组 & 干预措施
Arm I (1.5mg rasburicase)
Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
干预措施: rasburicase (Drug)
Arm I (1.5mg rasburicase)
Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
干预措施: allopurinol (Drug)
Arm II (3 mg rasburicase)
Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
干预措施: rasburicase (Drug)
Arm II (3 mg rasburicase)
Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
干预措施: allopurinol (Drug)
结局指标
主要结局
Probability of Obtaining a Uric Acid Level =< 7.5mg/dL
时间窗: Within 24 hours of rasburicase treatment
The proportion of patients able to achieve and/or maintain a uric acid level =\< 7.5mg/dL for each treatment arm.
次要结局
- Baseline White Blood Cell Count by Response(Up to day 7)
- Number of Patients Requiring Additional Doses of Rasburicase to Maintain a Uric Acid Level =< 7.5mg/dL(Up to day 7)
- Area Under the Plasma Uric Acid Concentration-time Curve (AUC) From Baseline (Day 1) to Day 7(Up to day 7)
- Safety of Low Single-doses of Rasburicase.(up to day 7)
- Number of Patients Experiencing a Doubling of Serum Creatinine(up to day 6)