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

This study has been terminated.
(due to poor enrollment)
Information provided by:
ClinicalTrials.gov Identifier:
First received: April 18, 2008
Last updated: March 6, 2012
Last verified: March 2012

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.

Condition Intervention Phase
Drug: Rasburicase (SR29142)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • responder rate (based on normalization of uric acid levels)

Enrollment: 33
Study Start Date: July 2002
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Patients with histologically proven aggressive Non Hodgkin's Lymphoma
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00664144

Sanofi-Aventis Administrative Office
Diegem, Belgium
Sanofi- Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Berlin, Germany
Sanofi-Aventis Administrative Office
Milan, Italy
Sponsors and Collaborators
Study Director: ICD Sanofi
  More Information

Responsible Party: ICD Study Director, Sanofi-aventis
ClinicalTrials.gov Identifier: NCT00664144     History of Changes
Other Study ID Numbers: EFC4983  L_8433 
Study First Received: April 18, 2008
Last Updated: March 6, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Pathologic Processes
Antirheumatic Agents
Gout Suppressants

ClinicalTrials.gov processed this record on May 26, 2016