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

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 )

First Received on April 18, 2008. Last Updated on March 27, 2009 History of Changes

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00664144

Purpose

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
Hyperuricemia	Drug: Rasburicase (SR29142)	Phase II

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:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Rasburicase

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Patients with histologically proven aggressive Non Hodgkin's Lymphoma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664144

Locations

Belgium
Sanofi-Aventis Administrative Office
Diegem, Belgium
France
Sanofi- Aventis Administrative Office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Italy
Sanofi-Aventis Administrative Office
Milan, Italy

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD

Sanofi-Aventis

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 27, 2009
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Non-Hodgkin
Tumor Lysis Syndrome
Hyperuricemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases

Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Rasburicase
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012