Rasburicase for the Treatment/Prevention of Hyperuricemia in Adult Patients With Relapsing Aggressive Non Hodgkin's Lymphoma
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperuricemia
Intervention: Rasburicase (SR29142) (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
ICD, Study Director, Affiliation: Sanofi-Aventis
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.
Clinical Details
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 Hodgkin's Lymphoma, Previously Treated or Not With Urate Oxidase Presenting With Hyperuricemia and/or Bulky Disease
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Efficacy Study
Primary outcome: responder rate (based on normalization of uric acid levels)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Patients with histologically proven aggressive Non Hodgkin's Lymphoma
Locations and Contacts
Sanofi-Aventis Administrative Office, Diegem, Belgium
Sanofi- Aventis Administrative Office, Paris, France
Sanofi-Aventis Administrative Office, Berlin, Germany
Sanofi-Aventis Administrative Office, Milan, Italy
Additional Information
Starting date: July 2002
Last updated: April 21, 2008
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