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
1 other identifier
observational
16
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2005
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedApril 25, 2017
October 1, 2011
4.9 years
September 12, 2005
April 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of grade 3 or 4 allergic reactions
Within 30 days of last treatment administration
Study Arms (1)
1
Interventions
Eligibility Criteria
Patients at high risk of tumor lysis syndrome who have a history of asthma, eczema, or significant allergies (to substances other than rasburicase).
You may qualify if:
- 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.
You may not qualify if:
- Wheezing or an active hypersensitivity reaction at entry.
- Hypersensitivity to Aspergillus proteins.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Jude Children's Research Hospitallead
- Sanoficollaborator
Study Sites (11)
Stanford University
Palo Alto, California, 94304, United States
Rady Children's Hospital
San Diego, California, 92123, United States
Peyton Manning Children's Hospital at St. Vincent
Indianapolis, Indiana, 46260, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115-6084, United States
Children's Hospital Michigan
Detroit, Michigan, 48201, United States
Columbia University Medical Center
New York, New York, 10032, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
St.Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Mid-West Children's Cancer Center
Milwaukee, Wisconsin, 53226-4801, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raul C. Ribeiro, MD
St. Jude Children's Research Hospital
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 16, 2005
Study Start
March 1, 2005
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
April 25, 2017
Record last verified: 2011-10