Post-Marketing Assessment of Immunogenicity and Safety of Unituxin® in High-Risk Neuroblastoma Patients
NCT ID: NCT02693171
Last Updated: 2019-08-05
Study Results
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View full resultsBasic Information
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TERMINATED
13 participants
OBSERVATIONAL
2016-03-15
2016-12-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Dinutuximab administered for 5 cycles
High-risk neuroblastoma patient treated with Unituxin as standard of care
Dinutuximab
Unituxin was administered along with cytokines according to the prescribing information
Interventions
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Dinutuximab
Unituxin was administered along with cytokines according to the prescribing information
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient had been prescribed Unituxin and plans to start Unituxin therapy within 30 days of study entry.
* Patient started Unituxin therapy no later than 200 days after Autologous Stem Cell Transplantation (ASCT).
* Written informed consent / assent was obtained in accordance with institutional and International Conference on Harmonisation (ICH) guidelines.
Exclusion Criteria
* Patient had participated in an investigational clinical trial with tumor therapeutic intent within 30 days of informed consent.
* Patient underwent Autologous Stem Cell Transplantation (ASCT) more than 200 days prior to receiving Unituxin therapy.
1 Year
18 Years
ALL
No
Sponsors
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United Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Ami Desai, MD
Role: STUDY_CHAIR
Children's Hospital of Philadelphia
Locations
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University Of Alabama At Birmingham
Birmingham, Alabama, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
Rady Children's Hospital- San Diego
San Diego, California, United States
University of Chicago
Chicago, Illinois, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan - C S Mott Children's Hospital
Ann Arbor, Michigan, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Columbia University Medical Center
New York, New York, United States
Carolinas Medical Center / Levine Children's Hospital
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Cook Children's Health Care System
Fort Worth, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Other Identifiers
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DIV-NB-401
Identifier Type: -
Identifier Source: org_study_id
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