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Rasburicase for the Treatment/Prevention of Hyperuricemia in Adult Patients With Relapsing Aggressive Non Hodgkin's Lymphoma — GRAAL2  

Hyperuricemia Clinical Trial

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

Clinical Trial 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 Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00664144
Study type Interventional
Source Sanofi
Contact
Status Terminated
Phase Phase 2
Start date July 2002
Completion date January 2005
View Details
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