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

Virchow Group

Status and phase: Completed; Phase 3

Conditions: Hyperuricemia

Treatments: Drug: TULY

Study type: Interventional

Funder types: Industry

Identifiers

NCT00921375

VB037/2007

VB037 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 patients

Sex: All

Ages: 1 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients of both genders aged between 1 to 75 years;
2. 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;
3. Eastern Cooperative Oncology Group (ECOG) performance scale of ≤3;
4. Patients scheduled to receive chemotherapy.

Exclusion criteria

1. Patients with allergy or asthma, or hypersensitivity to urate oxidase, or hemolytic reactions;
2. Pregnant and lactating;
3. Patients with glucose-6-phosphate dehydrogenase deficiency;
4. Exposure to rasburicase or allopurinol within 7 days;
5. History of psychiatric or co-morbid unstable medical conditions

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Tuly, uric acid lowering drug

Experimental group

Description:

TULY (rasburicase) 0.20 mg/kg body weight intravenously for 4 days

Treatment:

Drug: TULY