Safety and Efficacy of TULY (Rasburicase) in Prevention and Treatment of Malignancy-associated Hyperuricemia

Study Overview
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Brief Summary
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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 Description
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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.

Official Title
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Efficacy and Safety of TULY in Prevention and Treatment of Malignancy-associated Hyperuricemia

Conditions
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Hyperuricemia

Intervention / Treatment
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* Drug: TULY


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of both genders aged between 1 to 75 years; Patients with stage III or IV non-Hodgkin lymphoma (NHL) or acute lymphoblastic leukemia (ALL) with a peripheral WBC count of >25,000/µL or any leukemia or lymphoma with plasma uric acid level of at least 8 mg/dL; Eastern Cooperative Oncology Group (ECOG) performance scale of ≤3; Patients scheduled to receive chemotherapy. Exclusion Criteria: Patients with allergy or asthma, or hypersensitivity to urate oxidase, or hemolytic reactions; Pregnant and lactating; Patients with glucose-6-phosphate dehydrogenase deficiency; Exposure to rasburicase or allopurinol within 7 days; History of psychiatric or co-morbid unstable medical conditions

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tuly, uric acid lowering drug<br>TULY (rasburicase) 0.20 mg/kg body weight intravenously for 4 days | Drug: TULY<br>* TULY (rasburicase) 0.20 mg/kg body weight intravenously for 4 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of reduction in plasma uric acid at 4 hrs after uric acid-lowering therapy |  | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma uric acid AUC 0-96 hr |  | 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 |  | 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 |