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: April 18, 2008 Last Updated: March 27, 2009 History of Changes

Sponsored by:	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:	Treatment, Non-Randomized, Open Label, Uncontrolled, Efficacy Study
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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC4983, L 8433
Study First Received:	April 18, 2008
Last Updated:	March 27, 2009
ClinicalTrials.gov Identifier:	NCT00664144 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Lymphoma, Small Cleaved-cell, Diffuse
Lymphatic Diseases
Uric Acid
Immunoproliferative Disorders
Hyperuricemia
Tumor Lysis Syndrome

Antirheumatic Agents
Lymphoproliferative Disorders
Aggression
Lymphoma, Non-Hodgkin
Rasburicase
Lymphoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Hyperuricemia
Rasburicase
Gout Suppressants
Pharmacologic Actions
Lymphatic Diseases

Neoplasms
Pathologic Processes
Therapeutic Uses
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Antirheumatic Agents
Lymphoma

ClinicalTrials.gov processed this record on July 02, 2009