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Rasburicase as a Uricolytic Therapy for Hyperuricemia in Patients With Leukemia or Lymphoma

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: February 26, 2008
Last updated: October 1, 2009
Last verified: October 2009

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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:

Further study details as provided by Sanofi:

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)

Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
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Please refer to this study by its identifier: NCT00631579

Tokyo, Japan
Sponsors and Collaborators
Study Director: K.K. Sanofi
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Study Director, sanofi-aventis Identifier: NCT00631579     History of Changes
Other Study ID Numbers: ARD5290
Study First Received: February 26, 2008
Last Updated: October 1, 2009

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Gout Suppressants
Antirheumatic Agents processed this record on August 18, 2017