Fasturtec TLS Treatment / Prophylysis

• Status: Completed
• Trial end date: 2004-07-01
• Target enrollment: 0
• Participant gender: All

Summary

An open-label study to determine the efficacy and safety of Rasburicase used for the prevention and treatment of tumor lysis syndrome

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Rasburicase

Criteria

Inclusion Criteria:

• Chemotherapy planned for at least 3 cycles

• Undergoing cytoreductive chemotherapy for ALL, multiple myeloma or Burkitt's lymphoma stage III or IV

• With a minimum life expectancy of 3 months

• Uric acid > 8 mg%

• Negative pregnancy test < or =to 2 weeks and efficient contraceptive method.

• Negative HIV serology < or =to 4 weeks

• Patient or legal guardian has signed a written informed consent

Exclusion Criteria:

• Hypersensitivity to uricases or any of the excipients

• Known history of G6PD deficiency.

• Previous treatment with Rasburicase or Uricozyme®

• Pregnancy or lactation

• Treatment with any investigational drug within 30 days before planned first Rasburicase administration