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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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This is a multi-center trial for rasburicase in children at high risk of tumor lysis syndrome who have a history of asthma/atopy. The main purpose of this study is to establish the safety of this drug in patients with a history of asthma or severe allergies.
Because they were excluded from most of the clinical trials of non-recombinant urate oxidase and rasburicase, the safety of rasburicase in this population is not known, though preliminary data indicates that the drug is safe. The primary objective of this study is to estimate the proportion of grade 3 or 4 allergic reactions to rasburicase in patients with a history of asthma or severe allergy (to antigens other than rasburicase or other urate oxidases) treated with rasburicase for the prevention or treatment of malignancy or chemotherapy-induced hyperuricemia. Patients at risk of tumor lysis syndrome with a history of asthma/atopy will be treated with rasburicase according to standard practice and observed for allergic reactions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rasburicase | Drug | Rasburicase 0.2 mg/kg/dose by the intravenous route for up to 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of grade 3 or 4 allergic reactions | Within 30 days of last treatment administration |
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Inclusion Criteria:
Exclusion Criteria
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Patients at high risk of tumor lysis syndrome who have a history of asthma, eczema, or significant allergies (to substances other than rasburicase).
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| Name | Affiliation | Role |
|---|---|---|
| Raul C. Ribeiro, MD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States | ||
| Rady Children's Hospital |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
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| San Diego |
| California |
| 92123 |
| United States |
| Peyton Manning Children's Hospital at St. Vincent | Indianapolis | Indiana | 46260 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115-6084 | United States |
| Children's Hospital Michigan | Detroit | Michigan | 48201 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| St.Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Mid-West Children's Cancer Center | Milwaukee | Wisconsin | 53226-4801 | United States |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D015275 | Tumor Lysis Syndrome |
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C469709 | rasburicase |
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