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

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00631579
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Duration (Months): 14
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Hyperuricemia; Leukemia; Lymphoma	Drug: Rasburicase (SR29142)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• 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.
• Study Start Date: Apr 1, 2003
• Actual Primary Completion Date: Jun 1, 2004
• Actual Study Completion Date: Jun 1, 2004

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Pharmacokinetic parameters and anti-SR29142 antibodies []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 74 Years
• 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis	Tokyo		Japan

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: K.K., Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00631579
• Other Study ID Numbers: ARD5290
• First Posted: Mar 7, 2008
• Last Update Posted: Oct 2, 2009
• Last Verified: Oct 1, 2009

• Additional relevant MeSH terms: Lymphoma; Leukemia; Hyperuricemia; Rasburicase

Study Results

No Results Posted as of Oct 2, 2009