Phase 2 Study of Rasburicase Administered by Two Different Schedules (Fixed Dosing vs. As Needed Dosing) in Patients at High Risk or Potential Risk for Tumor Lysis Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Number of Participants With Plasma Uric Acid (UA) Response
研究概览
简要总结
Primary Objectives:
To determine the efficacy of rasburicase administered as a single dose followed by as needed dosing (investigational arm) as compared to fixed dosing for 5 days (standard treatment arm) in the treatment of patients at high risk or potential risk for tumor lysis syndrome.
Secondary Objectives:
- To evaluate the plasma uric acid area under the curve (AUC) from baseline through 7 days
- To evaluate the incidence of renal insufficiency and electrolyte abnormalities.
- To determine the safety and immunogenicity of rasburicase.
- To evaluate the cost-effectiveness of the experimental treatment (investigational arm).
详细描述
The Study Drug and TLS Rasburicase is designed to help decrease or prevent the high level of uric acid that may occur during the start of chemotherapy. A high level of uric acid in the blood may lead to decreased kidney function or kidney failure.
TLS occurs when high uric acid levels are caused by breakdown of tumor cells during the start of chemotherapy. The dead tumor cells can release uric acid and cause other symptoms of kidney failure, such as releasing large amounts of potassium and phosphorus (chemicals) into the blood.
Screening Tests Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study.
Your complete medical history will be recorded. You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate), height, and weight.
Blood will be drawn (about 2 tablespoons) for routine tests. Women who are able to have children must have a negative blood (using a sample from the routine blood draw) or urine pregnancy test.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hematological malignancies (leukemia/lymphoma) at high risk or potential risk for tumor lysis syndrome. High risk: hyperuricemia of malignancy (Uric acid levels >7.5); diagnosis of very aggressive lymphoma/leukemia based on Revised European-American Lymphoma (REAL) classification; acute myeloid leukemia, chronic myelocytic leukemia (CML) in blast crisis; high grade myelodysplastic syndrome only if they have >10% bone marrow blast involvement and given aggressive treatment similar to acute myeloid leukemia (AML) (continued on #2)
- •(continued from # 1) Potential risk: diagnosis of aggressive lymphoma/leukemia based on (REAL) classification. Plus one or more of the following criteria: lactate dehydrogenase (LDH) >/= 2 x upper limit of normal (ULN); Stage III-IV disease; Stage I-II disease with at least 1 lymph node/tumor >5cm in diameter.
- •ECOG performance status 0-3
- •Life expectancy >3 months
- •Negative pregnancy test (females of child bearing potential) within </=2 weeks of rasburicase dose and use of efficient contraceptive method (both males and females). Pregnancy test may be performed on serum (HCG) or urine (HCG)
- •Signed written informed consent (approved by the Institutional Review Board/Ethics Committee) obtained prior to study entry
排除标准
- •Patient receiving any investigational drug for hyperuricemia within 30 days of planned first treatment with rasburicase
- •Pregnancy or lactation
- •Known history of significant allergy problem or documented history of asthma or asthmatic bronchitis
- •Known history of glucose-6-phosphate dehydrogenase deficiency
- •Known history of hemolysis and methemoglobinemia
- •Previous therapy with urate oxidase
- •Other conditions unsuitable for participation in the trial in the Investigator's opinion
- •Unwillingness to comply with the requirements of the protocol
- •Use of allopurinol within 72 hours of the study entry
研究组 & 干预措施
Group A
As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
干预措施: As Needed Rasburicase (Drug)
Group B
Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
干预措施: Fixed Dose Rasburicase (Drug)
结局指标
主要结局
Number of Participants With Plasma Uric Acid (UA) Response
时间窗: First cycle of chemotherapy, up to 5 days
Plasma UA response is defined as normalization of plasma UA levels within 48 hours after the start of study drug (rasburicase) and maintaining within the normal range after the final drug infusion on day 5. Plasma samples for UA were collected at baseline before rasburicase, 4- and 24-hours post-rasburicase, and daily during treatment.
次要结局
未报告次要终点