Hyperuricemia, Leukemia, Lymphoma
Conditions
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.
Interventions
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety via physical examination, laboratory tests and adverse events. Efficacy via plasma uric acid levels. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters and anti-SR29142 antibodies | — |
Countries
Japan
Outcome results
None listed