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

Hyperuricemia Clinical Trial

— GRAAL2  

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 Details — Status: Terminated

Administrative data

• NCT number: NCT00664144
• Other study ID #: EFC4983
• Secondary ID: L_8433
• Status: Terminated
• Phase: Phase 2
• First received: April 18, 2008
• Last updated: March 6, 2012
• Start date: July 2002
• Est. completion date: January 2005

Study information

• Verified date: March 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older
• Eligibility: Patients with histologically proven aggressive Non Hodgkin's Lymphoma

Study Design

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

Related Conditions & MeSH terms

• Hyperuricemia
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• Rasburicase (SR29142)

Locations

Country	Name	City	State
Belgium	Sanofi-Aventis Administrative Office	Diegem
France	Sanofi- Aventis Administrative Office	Paris
Germany	Sanofi-Aventis Administrative Office	Berlin
Italy	Sanofi-Aventis Administrative Office	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	responder rate (based on normalization of uric acid levels)