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Post-Marketing Assessment of Immunogenicity and Safety of Unituxin® in High-Risk Neuroblastoma Patients
A Post-Marketing Study to Further Assess the Immunogenicity and Safety of Unituxin® in High-Risk Neuroblastoma Patients
1 other identifier
observational
13
1 country
18
Brief Summary
The purpose of this study was to assess the incidence of human anti-chimeric antibody (HACA) in high-risk neuroblastoma patients treated with Unituxin combination therapy.
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 2016
Shorter than P25 for all trials
18 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
First Submitted
Initial submission to the registry
February 23, 2016
CompletedFirst Posted
Study publicly available on registry
February 26, 2016
CompletedStudy Start
First participant enrolled
March 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2016
CompletedResults Posted
Study results publicly available
August 5, 2019
CompletedAugust 5, 2019
June 1, 2019
9 months
February 23, 2016
February 12, 2018
June 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
To Determine the Incidence of Human Anti-chimeric Antibody (HACA) in High-risk Neuroblastoma Patients Treated With Unituxin Combination Therapy.
Seven blood samples were collected at the following time points for the evaluation of HACA levels: * Course 1- Prior to the first Unituxin infusion * Course 2- Prior to the first Unituxin infusion * Course 3- Prior to the first Unituxin infusion * Course 4- Prior to the first Unituxin infusion * Course 5- Prior to the first Unituxin infusion * Course 6- Prior to the first dose of 13-cis-retinoic acid (RA) * Study termination (approximately 2 weeks following the final 13-cis-retinoic acid dose)
Approximately 6 months
Secondary Outcomes (3)
To Determine the Incidence of Targeted Immune-related Adverse Events (AEs) During Treatment With Dinutuximab Combination Therapy in High-risk Neuroblastoma Subjects.
Approximately 6 months
To Determine the Incidence of Neutralizing Antibody (NAb) in Patients With Human Anti-chimeric Antibody (HACA) Positive Samples.
Approximately 6 months
To Determine the Effect of HACA on Dinutuximab Plasma Concentrations.
Approximately 6 months
Study Arms (1)
Dinutuximab administered for 5 cycles
High-risk neuroblastoma patient treated with Unituxin as standard of care
Interventions
Unituxin was administered along with cytokines according to the prescribing information
Eligibility Criteria
High-risk neuroblastoma patients prescribed Unituxin
You may qualify if:
- Patient had been diagnosed with high-risk neuroblastoma.
- 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.
You may not qualify if:
- Patient had received prior anti-disialoganglioside (anti-GD2) antibody therapy.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
University Of Alabama At Birmingham
Birmingham, Alabama, 35233, United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Rady Children's Hospital- San Diego
San Diego, California, 92123, United States
University of Chicago
Chicago, Illinois, 60637, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Michigan - C S Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Columbia University Medical Center
New York, New York, 10032, United States
Carolinas Medical Center / Levine Children's Hospital
Charlotte, North Carolina, 28203, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, 17033, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Cook Children's Health Care System
Fort Worth, Texas, 76104, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Odette Jordan, MD, PMP
- Organization
- United Therapeutics Corp.
Study Officials
- STUDY CHAIR
Ami Desai, MD
Children's Hospital of Philadelphia
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2016
First Posted
February 26, 2016
Study Start
March 15, 2016
Primary Completion
December 19, 2016
Study Completion
December 19, 2016
Last Updated
August 5, 2019
Results First Posted
August 5, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share