Clinical Trial: Safety and Efficacy of TULY (Rasburicase) in Prevention and Treatment of Malignancy-associated Hyperuricemia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Efficacy and Safety of TULY in Prevention and Treatment of Malignancy-associated Hyperuricemia
Brief 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.
Detailed Summary: All eligible patients 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.
Sponsor: Virchow Group
Current Primary Outcome: Percentage of reduction in plasma uric acid at 4 hrs after uric acid-lowering therapy [ Time Frame: At the end of 4 hrs after initiation of uric acid lowering therapy; during 96 hrs of uric acid lowering therapy; Adverse events during the entire study period ]
Original Primary Outcome:
- Percentage of reduction in plasma uric acid at 4 hrs after uric acid-lowering therapy [ Time Frame: At the end of 4 hrs after initiation of uric acid lowering therapy; during 96 hrs of uric acid lowering therapy; Adverse events during the entire study period ]
- Plasma uric acid AUC 0-96 hr [ Time Frame: At the end of 4 hrs after initiation of uric acid lowering therapy; during 96 hrs of uric acid lowering therapy; Adverse events during the entire study period ]
- Incidence of adverse events [ Time Frame: At the end of 4 hrs after initiation of uric acid lowering therapy; during 96 hrs of uric acid lowering therapy; Adverse events during the entire study period ]
Current Secondary Outcome:
- Plasma uric acid AUC 0-96 hr [ Time Frame: At the end of 4 hrs after initiation of uric acid lowering therapy; during 96 hrs of uric acid lowering therapy; Adverse events during the entire study period ]
- Incidence of adverse events [ Time Frame: At the end of 4 hrs after initiation of uric acid lowering therapy; during 96 hrs of uric acid lowering therapy; Adverse events during the entire study period ]
Original Secondary Outcome:
Information By: Virchow Group
Dates:
Date Received: May 23, 2009
Date Started: February 2010
Date Completion:
Last Updated: December 11, 2014
Last Verified: December 2014