Status:
COMPLETED
Rasburicase Treatment for Chemotherapy or Malignancy-Induced Hyperuricemia in Asthma/Allergy Patients
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
Sanofi
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
Brief Summary
This is a multi-center trial for rasburicase in children at high risk of tumor lysis syndrome who have a history of asthma/atopy. The main purpose of this study is to establish the safety of this drug...
Detailed Description
Because they were excluded from most of the clinical trials of non-recombinant urate oxidase and rasburicase, the safety of rasburicase in this population is not known, though preliminary data indicat...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- A diagnosis of hematologic malignancy.
- Existing hyperuricemia or high risk of developing hyperuricemia of malignancy.
- The treating clinician plans to treat the patient with rasburicase. A patient is only eligible for RASALL if the clinician has already decided to use rasburicase. Rasburicase should not be given in order to make a patient eligible for this non-therapeutic observational study.
- No prior exposure to rasburicase or other urate oxidase.
- A history of asthma or significant allergy.
- Exclusion Criteria
- Wheezing or an active hypersensitivity reaction at entry.
- Hypersensitivity to Aspergillus proteins.
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00186940
Start Date
March 1 2005
End Date
February 1 2010
Last Update
April 25 2017
Active Locations (11)
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1
Stanford University
Palo Alto, California, United States, 94304
2
Rady Children's Hospital
San Diego, California, United States, 92123
3
Peyton Manning Children's Hospital at St. Vincent
Indianapolis, Indiana, United States, 46260
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115-6084