Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Primary: To estimate efficacy of SR29142 to the pediatric patients with newly diagnosed hematological malignancies at high risk for Tumor Lysis Syndrome, by evaluation of plasma uric acid concentration.
Secondary: To investigate the safety in this population and anti-SR29142 antibodies, anti-SCP antibodies, and pharmacokinetic parameters.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rasburicase (SR29142) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Patients with a plasma uric acid level decreased to the endpoint by 48 hr after the start of first drug infusion and lasting until 24 hr after the start of final (Day 5) drug infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety will be assessed on clinical observation, laboratory test, vital sign (blood pressure, pulse rate and body temperature), and the occurrence of adverse events. | ||
| G6PD activity will be measured in only patients who demonstrate hemolysis. |
Not provided
Inclusion Criteria:
Or, patient with newly diagnosed hematological malignancies presenting with high tumor burden defined:
Non-Hodgkin's lymphoma, Stage IV regardless of uric acid level,
Non-Hodgkin's Lymphomas stage III regardless of uric acid level with one of the following:
Acute leukemia with white blood cell count (WBC) ≥ 50,000/mm3 or LDH ≥ 3 x ULN (IU/L) regardless of uric acid level. etc.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Keiji OHNO | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis | Tokyo | Japan |
Not provided
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D033461 | Hyperuricemia |
| D008223 | Lymphoma |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C469709 | rasburicase |
| D014503 | Urate Oxidase |
| ID | Term |
|---|---|
| D010088 | Oxidoreductases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Anti-SR29142 antibody and Anti-SCP antibody will be measured. |
| PK parameters. |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006402 | Hematologic Diseases |