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An open-label study to determine the efficacy and safety of Rasburicase used for the prevention and treatment of tumor lysis syndrome
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| urate oxidase | Drug | First injection of Rasburicase will be done the day of initiation of chemotherapy, or the day before, according to hyperuricemia. Additional doses are permitted q12h during the first 72 hours of chemotherapy if hyperuricemia persists or subject is considered to be at significant risk of tumor lysis complications. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the uricolytic response to rasburicase treatment | 5 weeks (3 to 7 days of treatment, with follow-up of 4 weeks after the last study drug injection) |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate tumor lysis risk factors, treatments for tumor lysis syndrome and complications of treatment in patients treated prophylactically or therapeutically for tumor lysis syndrome | 5 weeks (3 to 7 days of treatment, with follow-up of 4 weeks after the last study drug injection) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Chang | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis | Bridgewater | New Jersey | 08807 | United States |
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| ID | Term |
|---|---|
| D015275 | Tumor Lysis Syndrome |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
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| ID | Term |
|---|---|
| D014503 | Urate Oxidase |
| C469709 | rasburicase |
| ID | Term |
|---|---|
| D010088 | Oxidoreductases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
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| D007154 | Immune System Diseases |