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Rasburicase Treatment for Chemotherapy or Malignancy-Induced Hyperuricemia in Asthma/Allergy Patients

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ClinicalTrials.gov Identifier: NCT00186940
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : April 25, 2017
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

September 12, 2005
September 16, 2005
April 25, 2017
March 2005
February 2010   (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 ]
Incidence of grade 3 or 4 allergic reactions
Complete list of historical versions of study NCT00186940 on ClinicalTrials.gov Archive Site
Not Provided
Reduction in uric acid levels, renal failure
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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.
Observational
Observational Model: Other
Time Perspective: Prospective
Not Provided
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Non-Probability Sample
Patients at high risk of tumor lysis syndrome who have a history of asthma, eczema, or significant allergies (to substances other than rasburicase).
  • Leukemia
  • Lymphoma
  • Tumor Lysis Syndrome
  • Hyperuricemia
Drug: Rasburicase
Rasburicase 0.2 mg/kg/dose by the intravenous route for up to 7 days.
1
Intervention: Drug: Rasburicase
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
72
February 2010
February 2010   (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.
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00186940
RASALL
No
Not Provided
Not Provided
St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
Sanofi
Principal Investigator: Raul C. Ribeiro, MD St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
October 2011