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

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Leukemia Lymphoma

Drug Information available for: Rasburicase

U.S. FDA Resources

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

No publications provided by Sanofi-Aventis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ishizawa K, Ogura M, Hamaguchi M, Hotta T, Ohnishi K, Sasaki T, Sakamaki H, Yokoyama H, Harigae H, Morishima Y. Safety and efficacy of rasburicase (SR29142) in a Japanese phase II study. Cancer Sci. 2009 Feb;100(2):357-62.

Responsible Party:	Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00631579 History of Changes
Other Study ID Numbers:	ARD5290
Study First Received:	February 26, 2008
Last Updated:	October 1, 2009
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:

Leukemia
Lymphoma
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 12, 2012