Safety and Efficacy of TULY (Rasburicase) in Prevention and Treatment of Malignancy-associated Hyperuricemia
Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
Participant gender:
Summary
This study is a prospective, open-label, multicentre study. Hundred eligible patients with
stage III or IV non-Hodgkin lymphoma (NHL) or acute lymphoblastic leukemia (ALL) with a
peripheral white blood cell (WBC) count of > 25,000/µL or any leukemia or lymphoma with
plasma uric acid level of at least 8 mg/dL will be treated with rasburicase 0.20 mg/kg body
weight intravenously for 4 days. The primary endpoints viz., the percentage of reduction in
plasma uric acid at 4 hrs after uric acid-lowering therapy, plasma uric acid AUC 0-96 hr and
incidence of adverse events will be assessed during 11 days study period.