NCT00664144

Rasburicase for the Treatment/Prevention of Hyperuricemia in Adult Patients With Relapsing Aggressive Non Hodgkin's Lymphoma

Study of Efficacy and Safety of Rasburicase for the Treatment/Prevention of Hyperuricemia Related to Tumor Lysis Syndrome in Adult Patients With Relapsing Aggressive Non Hodgkin's Lymphoma, Previously Treated or Not With Urate Oxidase Presenting With Hyperuricemia and/or Bulky Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective was to evaluate the efficacy of rasburicase in terms of prevention and treatment of hyperuricemia related to Tumor Lysis Syndrome (TLS) in 2 populations of adult patients, previously treated or not with urate oxidase, with relapsing aggressive non-Hodgkin's lymphoma (NHL) and at risk of TLS, presenting with hyperuricemia and/or bulky disease at diagnostic of relapse. The secondary objectives were to : * evaluate the efficacy of rasburicase in terms of renal protection, * evaluate the safety of rasburicase in the two cohorts of patients, * correlate efficacy and safety results with antibodies generation/level.

Conditions

• Hyperuricemia

Interventions

Type	Name	Description
DRUG	Rasburicase (SR29142)

Timeline

• Start date: 2002-07-01
• Primary completion: 2005-01-01
• Completion: 2005-01-01
• First posted: 2008-04-22
• Last updated: 2012-03-07

Locations

4 sites across 4 countries: Belgium, France, Germany, Italy