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Spots Global Cancer Trial Database for Study of Rasburicase as Treatment or Prevention of Hyperuricemia Associated With Tumor Lysis Syndrome in Patients With Relapsed or Refractory Lymphoma, Leukemia, or Solid Tumor Malignancy

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Trial Identification

Brief Title: Study of Rasburicase as Treatment or Prevention of Hyperuricemia Associated With Tumor Lysis Syndrome in Patients With Relapsed or Refractory Lymphoma, Leukemia, or Solid Tumor Malignancy

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

Study ID: NCT00230217

Study Description

Brief Summary: 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.

Detailed Description: 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.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: ICD CSD

Affiliation: Sanofi

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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