Clinical Trial: Rasburicase for the Treatment/Prevention of Hyperuricemia in Adult Patients With Relapsing Aggressive Non Hodgkin's Lymphoma
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: 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 H
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 Summary:
Sponsor: Sanofi
Current Primary Outcome: responder rate (based on normalization of uric acid levels)
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Sanofi
Dates:
Date Received: April 18, 2008
Date Started: July 2002
Date Completion:
Last Updated: March 6, 2012
Last Verified: March 2012
