NCT00230217

Study of Rasburicase as Treatment or Prevention of Hyperuricemia Associated With Tumor Lysis Syndrome in Patients With Relapsed or Refractory Lymphoma, Leukemia, or Solid Tumor Malignancy

Evaluation of Single Agent Rasburicase in Treatment/Prevention of Hyperuricemia Associated With Tumor Lysis Syndrome in Adult and Pediatric Patients With Lymphoma/Leukemia/Solid Tumor Malignancies at Their First Relapse or Refractory Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is an open-label, multi-center study with 2 arms. The primary objective is to assess the response to treatment with rasburicase in 2 populations of adult and pediatric patients with lymphoma/leukemia/solid tumor malignancies, those previously treated with a uricolytic agent, and those not previously treated with a uricolytic agent at their first relapse or refractory disease.

Detailed description

This is a multi-center, 2 arm, open-label study; * Arm A: Patients previously treated with a uricolytic agent; * Arm B: Patients not previously treated with a uricolytic agent. Patients receive rasburicase for 5 days and begin chemotherapy 4-24 hours after the first dose of rasburicase. Patients are followed at 14 and 35 days, at 3 and 6 months and every 6 months thereafter.

Conditions

• Tumors
• Hyperuricemia
• Tumor Lysis Syndrome

Interventions

Type	Name	Description
DRUG	Rasburicase (SR29142)

Timeline

• Start date: 2004-03-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2005-09-30
• Last updated: 2009-03-30

Locations

7 sites across 1 country: United States