This is an open-label, multi-center study with 2 arms. The primary objective is to assess the response to treatment with rasburicase in 2 populations of adult and pediatric patients with lymphoma/leukemia/solid tumor malignancies, those previously treated with a uricolytic agent, and those not previously treated with a uricolytic agent at their first relapse or refractory disease.
This is a multi-center, 2 arm, open-label study; * Arm A: Patients previously treated with a uricolytic agent; * Arm B: Patients not previously treated with a uricolytic agent. Patients receive rasburicase for 5 days and begin chemotherapy 4-24 hours after the first dose of rasburicase. Patients are followed at 14 and 35 days, at 3 and 6 months and every 6 months thereafter.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
94
Alta Bates Comprehensive Cancer Center
Berkley, California, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
University of Florida Health Science Center at Jacksonville
Jacksonville, Florida, United States
New York Medical College
Valhalla, New York, United States
University of Oklahoma HSC
Oklahoma City, Oklahoma, United States
University of Pennsylvania Health Systems
Philadelphia, Pennsylvania, United States
Mary Babb Randolph Cancer Center
Morgantown, West Virginia, United States
Positive response based on plasma uric acid levels.
Time frame: up to 48 hours after last administration.
safety assessment
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