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Completed

NCT Number: NCT00186940

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University, Palo Alto, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rasburicase

Drug

Rasburicase 0.2 mg/kg/dose by the intravenous route for up to 7 days.

Primary outcomes

  1. Incidence of grade 3 or 4 allergic reactions

    Time frame: Within 30 days of last treatment administration

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Collaborators

  • Sanofi

Registry information

Official study title

A Study of Rasburicase Treatment for Chemotherapy of Malignancy-Induced Hyperuricemia in Patients With a History of Asthma Allergies

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Sep 16, 2005
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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