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Brief Title: Rasburicase for the Treatment/Prevention of Hyperuricemia in Adult Patients With Relapsing Aggressive Non Hodgkin's Lymphoma
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 ID: NCT00664144
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Sanofi-Aventis Administrative Office, Diegem, , Belgium
Sanofi- Aventis Administrative Office, Paris, , France
Sanofi-Aventis Administrative Office, Berlin, , Germany
Sanofi-Aventis Administrative Office, Milan, , Italy
Name: ICD
Affiliation: Sanofi
Role: STUDY_DIRECTOR