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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00631579
First received: February 26, 2008
Last updated: October 1, 2009
Last verified: October 2009

February 26, 2008
October 1, 2009
April 2003
June 2004   (final data collection date for primary outcome measure)
Safety via physical examination, laboratory tests and adverse events. Efficacy via plasma uric acid levels.
Same as current
Complete list of historical versions of study NCT00631579 on ClinicalTrials.gov Archive Site
Pharmacokinetic parameters and anti-SR29142 antibodies
Same as current
Not Provided
Not Provided
 
Rasburicase as a Uricolytic Therapy for Hyperuricemia in Patients With Leukemia or Lymphoma
Open-label, Multicenter Study of Repeated Doses of SR29142 (Rasburicase) as a Uricolytic Therapy for Hyperuricemia in Adult Patients With Leukemia or Lymphoma.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hyperuricemia
  • Leukemia
  • Lymphoma
Drug: Rasburicase (SR29142)
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2004
June 2004   (final data collection date for primary outcome measure)

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).
Both
18 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00631579
ARD5290
Not Provided
Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: K.K. Sanofi
Sanofi
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP