NCT00230178

Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome

Evaluation of Single Agent Rasburicase for 5 Days Versus Sequential Treatment With Rasburicase From Day 1 Through 3 Followed by Oral Allopurinol From Day 3 Through 5 (Overlap on Day 3) Versus Single Agent Oral Allopurinol for 5 Days in the Management of Plasma Uric Acid in Adult Patients With Leukemia, Lymphoma, and Solid Tumor Malignancies at Risk for Hyperuricemia and Tumor Lysis Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, multi-center, open-label, parallel group study with three arms: * Rasburicase alone * Rasburicase followed by Allopurinol * Allopurinol alone The primary objective is to compare the adequacy of control of plasma uric acid concentration and the safety profile among the three arms.

Detailed description

After signing the informed consent and having met the inclusion criteria, patients will be randomized to 1 of the 3 arms and treated for a total duration of 5 days. Patients in all arms will receive chemotherapy beginning 4-24 hours after the first dose of rasburicase or allopurinol.

Conditions

• Tumor Lysis Syndrome
• Cancer
• Hyperuricemia

Interventions

Type	Name	Description
DRUG	Rasburicase (SR29142)	30-min IV infusion
DRUG	Allopurinol	Oral administration

Timeline

• Start date: 2004-04-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2005-09-30
• Last updated: 2010-01-12
• Results posted: 2009-12-31

Locations

15 sites across 1 country: United States