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 ).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
0.20mg/kg per day IV
100mg tablets
Sanofi-Aventis Administrative Office
Shanghai, China
Mean plasma uric acid AUC0-96
Time frame: 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)
Time frame: From administration of drug up to end of study
Biochemistry, hematology, vital signs, physical examination, and adverse events
Time frame: From administration of drug up to end of study
Proportion of patients developing hypertension requiring therapy
Time frame: From administration of drug up to end of study
Assays for circulating antibodies
Time frame: From administration of drug up to end of study
Percentage reduction of plasma uric acid concentrations at T4h
Time frame: From administration of drug up to end of study
Mean plasma uric acid concentrations
Time frame: At various timepoints
Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL
Time frame: From administration of drug up to end of study
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