drugset / Trial / NCT00664144

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

NCT00664144

Phase 2 Terminated 33 enrolled Sanofi
Non-randomizedOpen-labelTreatment

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.

Timeline

Start
2002-07
Primary completion
2005-01
Completion
2005-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Rasburicase Protein / enzyme biologic

Indications

No indication recorded.