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

No publications provided

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
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2015