Rasburicase (Fasturtec) Registration Trial

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

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 ).

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.