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

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virchow Group
• Treatments: Rasburicase

Criteria

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