Rasburicase (Fasturtec) Registration Trial

Study Overview
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Brief Summary
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Primary: To compare the efficacy of Rasburicase versus allopurinol in controlling tumor lysis-related hyperuricemia in Chinese patients with leukemia or lymphoma. Secondary: To compare the efficacy and safety of Rasburicase versus allopurinol in Chinese patients stratified according to disease (leukemia or lymphoma ).

Official Title
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A Multi-center, Randomized, Open-label, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Rasburicase (Fasturtec®) in the Prevention and Treatment of Hyperuricemia in Patients With Hematological Malignancies

Conditions
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Hyperuricemia

Intervention / Treatment
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* Drug: Rasburicase
* Drug: Allopurinol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At high risk of malignancy and/or chemotherapy-induced hyperuricemia Performance status less than 3 on ECOG scale or more than 30% KPS scale Uric acid concentrations ≥ 8.0mg/dL Suffering from non-Hodgkin's lymphoma Stage more than III, or acute lymphoblastic leukemia with peripheral with blood cell count more than 25,000/mm3, or any lymphoma or leukemia Exclusion Criteria: Treatment with an investigational drug at any time during the 14-day study period (except for agents that are permitted by the Sponsor) Pregnancy or lactation Prior treatment with Uricozyme or Rasburicase Scheduled to receive asparaginase either 24 hours after the first dose of rasburicase Treatment with Allopurinol within the seven days preceding study Day 1 History of significant atopic allergy problems or documented history of asthma History of severe reaction to allopurinol Known history of glucose-6-phosphate dehydrogenase deficiency. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>IV infusion at a dose level of 0.20mg/kg per day | Drug: Rasburicase<br>* 0.20mg/kg per day IV<br>|
| Active Comparator: 2<br>100mg tablets, administered orally, according to standard medical practice | Drug: Allopurinol<br>* 100mg tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean plasma uric acid AUC0-96 |  | 0hour, 4hour, 12 hour and q12h thereafter | 
| Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL (only in patients hyperuricemic immediately prior to dosing) |  | From administration of drug up to end of study | 
| Biochemistry, hematology, vital signs, physical examination, and adverse events |  | From administration of drug up to end of study | 
| Proportion of patients developing hypertension requiring therapy |  | From administration of drug up to end of study | 
| Assays for circulating antibodies |  | From administration of drug up to end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage reduction of plasma uric acid concentrations at T4h |  | From administration of drug up to end of study | 
| Mean plasma uric acid concentrations |  | At various timepoints | 
| Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL |  | From administration of drug up to end of study |