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
months thereafter.
Interventional
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.
ICD CSD
Study Director
Sanofi
United States: Food and Drug Administration
EFC5339
NCT00230217
March 2004
July 2006
Name | Location |
---|---|
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 |