Evaluation of Single Agent Rasburicase for 5 Days Versus Sequential Treatment With Rasburicase From Day 1 Through 3 Followed by Oral Allopurinol From Day 3 Through 5 (Overlap on Day 3) Versus Single Agent Oral Allopurinol for 5 Days in the Management of Plasma Uric Acid in Adult Patients With Leukemia, Lymphoma, and Solid Tumor Malignancies at Risk for Hyperuricemia and Tumor Lysis Syndrome
After signing the informed consent and having met the inclusion criteria, patients will be
randomized to 1 of the 3 arms and treated for a total duration of 5 days. Patients in all
arms will receive chemotherapy beginning 4-24 hours after the first dose of rasburicase or
allopurinol.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Plasma Uric Acid Responder
Day 3 through Day 7
No
International Clinical Development
Study Director
Sanofi
United States: Food and Drug Administration
EFC4978
NCT00230178
April 2004
December 2007
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
New York Methodist Hospital | Brooklyn, New York 11215-3609 |
New York Medical College | Valhalla, New York 10595 |
University of Rochester Medical Center | Rochester, New York 14642 |
Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
Rocky Mountain Cancer Center | Denver, Colorado 80218 |
Alta Bates Comprehensive Cancer Center | Berkeley, California 94704 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
Duke University Medical Center | Durham, North Carolina 27710 |
University of Pennsylvania Health Systems | Philadelphia, Pennsylvania 19104-9104 |
UCLA Medical Center | Los Angeles, California 90095-7059 |
Oregon Health and Sciences University | Portland, Oregon |
Mary Babb Randolph Cancer Center | Morgantown, West Virginia 26506 |
University of Texas MD Anderson Cancer Center | Houston, Texas 77030 |
University of Florida Health Science Center at Jacksonville | Jacksonville, Florida 32209 |