Status:
COMPLETED
Safety and Efficacy of TULY (Rasburicase) in Prevention and Treatment of Malignancy-associated Hyperuricemia
Lead Sponsor:
Virchow Group
Conditions:
Hyperuricemia
Eligibility:
All Genders
1-75 years
Phase:
PHASE3
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 bloo...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00921375
Start Date
February 1 2010
End Date
January 1 2012
Last Update
December 12 2014
Active Locations (1)
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1
Dr. Raghunathrao
Hyd, Andhra Pradesh, India