Rasburicase (Fasturtec) Registration Trial

• Status: Terminated
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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 ).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Allopurinol; Rasburicase

Criteria

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.