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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00186940

Enrollment

Registered

2005-09-16

Start date

2005-03-31

Completion date

2010-02-28

Last updated

2017-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Lymphoma, Tumor Lysis Syndrome, Hyperuricemia

Keywords

leukemia

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 in patients with a history of asthma or severe allergies.

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 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.

Interventions

DRUGRasburicase

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

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Incidence of grade 3 or 4 allergic reactions	Within 30 days of last treatment administration

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026