Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00230178 | Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome | PHASE3 | COMPLETED | 280 | — | — | Apr 1, 2004 | Dec 1, 2007 | Jan 12, 2010 | 15 | United States |
Number of patients responding to treatment defined as plasma uric acid levels at Day 3 through Day 7 \<7.5 mg/dl.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Rasburicase alone given as a single agent for 5 days |
| Arm B | EXPERIMENTAL | Rasburicase alone given as a single agent from Day 1 through Day 3, followed by oral allopurinol given from Day 3 through Day 5 (Day 3 is an overlap) |
| Arm C | ACTIVE_COMPARATOR | Oral allopurinol alone given as a single agent for 5 days |
| Name | Type | Description |
|---|---|---|
| Rasburicase (SR29142) | DRUG | 30-min IV infusion |
| Allopurinol | DRUG | Oral administration |
Inclusion Criteria: 1. Meets high risk or at potential risk for tumor lysis syndrome (TLS): A patient is at high risk for TLS if he/she presents with: * Hyperuricemia of malignancy (plasma uric acid \> 7.5 mg/dL); * A diagnosis of very aggressive lymphoma/leukemia based on the Revised Eur...