Back to resultsRasburicase as a Uricolytic Therapy for Hyperuricemia in Patients With Leukemia or Lymphoma
Primary Purpose
Hyperuricemia, Leukemia, Lymphoma
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Rasburicase (SR29142)
Sponsored by
About this trial
This is an interventional treatment trial for Hyperuricemia
Eligibility 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).
Sites / Locations
- Sanofi-Aventis
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00631579
Brief Title
Rasburicase as a Uricolytic Therapy for Hyperuricemia in Patients With Leukemia or Lymphoma
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 Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
June 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia, Leukemia, Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rasburicase (SR29142)
Primary Outcome Measure Information:
Title
Safety via physical examination, laboratory tests and adverse events. Efficacy via plasma uric acid levels.
Secondary Outcome Measure Information:
Title
Pharmacokinetic parameters and anti-SR29142 antibodies
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
K.K.
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
19076979
Citation
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. doi: 10.1111/j.1349-7006.2008.01047.x.
Results Reference
derived
Learn more about this trial
Rasburicase as a Uricolytic Therapy for Hyperuricemia in Patients With Leukemia or Lymphoma
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