Evaluation of Single Agent Rasburicase in Treatment/Prevention of Hyperuricemia Associated With Tumor Lysis Syndrome in Adult and Pediatric Patients With Lymphoma/Leukemia/Solid Tumor Malignancies 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
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Positive response based on plasma uric acid levels.
up to 48 hours after last administration.
United States: Food and Drug Administration
|New York Medical College||Valhalla, New York 10595|
|Rocky Mountain Cancer Center||Denver, Colorado 80218|
|Alta Bates Comprehensive Cancer Center||Berkeley, California 94704|
|University of Pennsylvania Health Systems||Philadelphia, Pennsylvania 19104-9104|
|Mary Babb Randolph Cancer Center||Morgantown, West Virginia 26506|
|University of Florida Health Science Center at Jacksonville||Jacksonville, Florida 32209|
|University of Oklahoma HSC||Oklahoma City, Oklahoma 73104|