An observational study in Leukemia, Lymphoma and Tumor Lysis Syndrome, sponsored by St. Jude Children's Research Hospital. Completed at 11 sites in United States. Per ClinicalTrials.gov, last updated 2017-04-25.
Sponsored by St. Jude Children's Research Hospital · Observational
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 in patients with a history of asthma or severe allergies.
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 indicates that the drug is safe. The primary objective of this study is to estimate the proportion of grade 3 or 4 allergic reactions to rasburicase in patients with a history of asthma or severe allergy (to antigens other than rasburicase or other urate oxidases) treated with rasburicase for the prevention or treatment of malignancy or chemotherapy-induced hyperuricemia. Patients at risk of tumor lysis syndrome with a history of asthma/atopy will be treated with rasburicase according to standard practice and observed for allergic reactions.
215 studies on the registry are indexed under Hyperuricemia; 40 are open to participants now.
This study's enrollment of 16 is below the median of 200 across 37 observational studies indexed under Hyperuricemia.
Browse Hyperuricemia studies →St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients at high risk of tumor lysis syndrome who have a history of asthma, eczema, or significant allergies (to substances other than rasburicase).
Exclusion Criteria
Drug: Rasburicase
Rasburicase 0.2 mg/kg/dose by the intravenous route for up to 7 days.
Incidence of grade 3 or 4 allergic reactions
Time frame: Within 30 days of last treatment administration
This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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Tumor Lysis Syndrome
St. Jude Children's Research Hospital