Lymphoma Clinical Trial
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.
Verified date | October 2009 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Ministry of Health, Labor and Welfare |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | June 2004 |
Est. primary completion date | June 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 74 Years |
Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | Sanofi-Aventis | Tokyo |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety via physical examination, laboratory tests and adverse events. Efficacy via plasma uric acid levels. | |||
Secondary | Pharmacokinetic parameters and anti-SR29142 antibodies |
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