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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00230217 |
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.
Condition | Intervention | Phase |
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Tumors Hyperuricemia Tumor Lysis Syndrome |
Drug: Rasburicase (SR29142) |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment |
Official Title: | 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 |
Enrollment: | 94 |
Study Start Date: | March 2004 |
Study Completion Date: | July 2006 |
Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
This is a multi-center, 2 arm, open-label study;
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Meets one of the following risk criteria for tumor lysis syndrome (TLS):
A patient is at high risk for TLS if he/she presents with:
A patient is at potential risk for TLS if he/she presents with:
A diagnosis of an aggressive lymphoma/leukemia based on the REAL classification of lymphoma/leukemia plus 1 or more of the following criteria:
Exclusion Criteria:
United States, California | |
Alta Bates Comprehensive Cancer Center | |
Berkley, California, United States, 94704 | |
United States, Colorado | |
Rocky Mountain Cancer Center | |
Denver, Colorado, United States, 80218 | |
United States, Florida | |
University of Florida Health Science Center at Jacksonville | |
Jacksonville, Florida, United States, 32209 | |
United States, New York | |
New York Medical College | |
Valhalla, New York, United States, 10595 | |
United States, Oklahoma | |
University of Oklahoma HSC | |
Oklahoma City, Oklahoma, United States, 73104 | |
United States, Pennsylvania | |
University of Pennsylvania Health Systems | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, West Virginia | |
Mary Babb Randolph Cancer Center | |
Morgantown, West Virginia, United States, 26506-9162 |
Study Director: | ICD CSD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC5339 |
Study First Received: | September 28, 2005 |
Last Updated: | March 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00230217 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Relapse Refracturing Leukemia Lymphoma Solid Tumor |
Lymphatic Diseases Leukemia Immunoproliferative Disorders Hyperuricemia Tumor Lysis Syndrome |
Antirheumatic Agents Lymphoproliferative Disorders Rasburicase Lymphoma |
Neoplasms by Histologic Type Immunoproliferative Disorders Disease Immune System Diseases Hyperuricemia Gout Suppressants Rasburicase Pharmacologic Actions Leukemia |
Lymphatic Diseases Neoplasms Pathologic Processes Therapeutic Uses Syndrome Tumor Lysis Syndrome Antirheumatic Agents Lymphoproliferative Disorders Lymphoma |