Hyperuricemia
Conditions
Brief summary
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 ).
Interventions
DRUGRasburicase
0.20mg/kg per day IV
DRUGAllopurinol
100mg tablets
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assays for circulating antibodies | From administration of drug up to end of study |
| 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 |
| Mean plasma uric acid AUC0-96 | 0hour, 4hour, 12 hour and q12h thereafter |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Percentage reduction of plasma uric acid concentrations at T4h | From administration of drug up to end of study |
Countries
China
Outcome results
None listed