Rasburicase as a Uricolytic Therapy for Hyperuricemia in Patients With Leukemia or Lymphoma - Full Text View

Purpose

The primary objectives of the study are to evaluate the safety and the efficacy in patients with malignant lymphoma or acute leukemia who are repeatedly administered for SR29142 5 days in two dosage groups.

Secondary objectives are to determine the pharmacokinetic (PK) parameters of SR29142 , to assess anti-SR29142 antibody production in patients with malignant lymphoma and acute leukemia, and to estimate the optimal dosage of SR29142 for Japanese patients from the results of efficacy and safety evaluations.

Condition	Intervention	Phase
Hyperuricemia Leukemia Lymphoma	Drug: Rasburicase (SR29142)	Phase II

MedlinePlus related topics:

Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma

ChemIDplus related topics:

Rasburicase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Official Title:	Open-Label, Multicenter Study of Repeated Doses of SR29142 (Rasburicase) as a Uricolytic Therapy for Hyperuricemia in Adult Patients With Leukemia or Lymphoma.

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Safety via physical examination, laboratory tests and adverse events. Efficacy via plasma uric acid levels.

Secondary Outcome Measures:

Pharmacokinetic parameters and anti-SR29142 antibodies

Enrollment:	50
Study Start Date:	April 2003
Study Completion Date:	June 2004
Primary Completion Date:	June 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient suffering from:

acute leukemia with white blood cell (WBC) count≥ 20,000/mm3 without regard to uric acid level ; or
lymphoma,Stage ≥ III without regard to uric acid level; or
lymphomas, Stage II with bulky disease; or
lymphoma or leukemia, without regard to classification or morphology, with uric acid level ≥ 8.0 mg/dL, and lactate dehydrogenase (LDH) level ≥ twice the upper limit of normal (ULN).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631579

Locations


Japan
	Sanofi-Aventis
	Tokyo, Japan

Sponsors and Collaborators

Sanofi-Aventis

Investigators


Study Director:	K.K.	Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( Study Director )
Study ID Numbers:	ARD5290, SR29142
First Received:	February 26, 2008
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00631579
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Lymphatic Diseases

Leukemia

Immunoproliferative Disorders

Hyperuricemia

Lymphoproliferative Disorders

Rasburicase

Lymphoma

Additional relevant MeSH terms:

Neoplasms

Pathologic Processes

Neoplasms by Histologic Type

Immune System Diseases

Therapeutic Uses

Antirheumatic Agents

Gout Suppressants

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00631579