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Rasburicase Treatment for Chemotherapy or Malignancy-Induced Hyperuricemia in Asthma/Allergy Patients
This study is ongoing, but not recruiting participants.
Study NCT00186940   Information provided by St. Jude Children's Research Hospital
First Received: September 12, 2005   Last Updated: November 4, 2009   History of Changes

September 12, 2005
November 4, 2009
March 2005
December 2009   (final data collection date for primary outcome measure)
Incidence of grade 3 or 4 allergic reactions [ Time Frame: Within 30 days of last treatment administration ] [ Designated as safety issue: Yes ]
Incidence of grade 3 or 4 allergic reactions
Complete list of historical versions of study NCT00186940 on ClinicalTrials.gov Archive Site
 
Reduction in uric acid levels, renal failure
 
Rasburicase Treatment for Chemotherapy or Malignancy-Induced Hyperuricemia in Asthma/Allergy Patients
A Study of Rasburicase Treatment for Chemotherapy of Malignancy-Induced Hyperuricemia in Patients With a History of Asthma Allergies

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.

Phase IV
Observational
Other, Prospective
  • Leukemia
  • Lymphoma
  • Tumor Lysis Syndrome
  • Hyperuricemia
Drug: Rasburicase
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
72
December 2009
December 2009   (final data collection date for primary outcome measure)

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.
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00186940
Raul C. Ribeiro, Principal Investigator, St. Jude Children's Research Hospital
RASALL
St. Jude Children's Research Hospital
Sanofi-Aventis
Principal Investigator: Raul C. Ribeiro, MD St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP