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

Phase 2

Terminated

• Conditions: Hyperuricemia

• Registration Number: NCT00664144
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-07
• Primary Completion: 2005-01
• Study Completion: 2005-01
• Study First Submitted: 2008-04-18
• Study First Submitted QC: 2008-04-21
• Study First Posted: 2008-04-22
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-06
• Last Update Posted: 2012-03-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
responder rate (based on normalization of uric acid levels)

Trial Locations

Locations (2)

Sanofi- Aventis Administrative Office; 🇫🇷 Paris, France

Sanofi-Aventis Administrative Office; 🇮🇹 Milan, Italy