Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome

Summary

This is a randomized, multi-center, open-label, parallel group study with three arms: * Rasburicase alone * Rasburicase followed by Allopurinol * Allopurinol alone The primary objective is to compare the adequacy of control of plasma uric acid concentration and the safety profile among the three arms.

Timeline

Start

2004-04

Primary completion

2007-12

Completion

2007-12

Outcome

Met primary endpoint

registry analysis (superiority or other test); Rasburicase vs Allopurinol; p = 0.0009; Difference in response rate % 21 (95% CI 8.6 to 32.7); Wilson's method NCT00230178 ↗

Drugs

Indications