Fasturtec TLS Treatment / Prophylysis

Sanofi

Status and phase: Completed; Phase 4

Conditions: Tumor Lysis Syndrome

Treatments: Drug: urate oxidase

Study type: Interventional

Funder types: Industry

Identifiers

NCT00651911

L_8637

Details and patient eligibility

About

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

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)