A Randomized, Multicenter, Open-label, Comparison of Rasburicase (Fasturtec) Versus Allopurinol for the Prophylaxis and Treatment of Hyperuricemia in Chinese Patients With Leukaemia or Lymphoma
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.