About this trial
This study looks at how well adding a medicine called dinutuximab to standard treatments works for children with high-risk neuroblastoma. The goal is to see if this combination helps children do better after starting treatment. Dinutuximab helps the immune system find and attack cancer cells. The trial compares two groups: one that gets standard treatment and another that receives dinutuximab along with their treatment.
The trial ID is NCT06172296. This is a Phase 3 study, which means it is testing how well the treatment works and its safety. The trial is FDA-regulated and plans to include about 478 participants.
Who can join
Children and young adults up to 30 years old can join if they have been diagnosed with high-risk neuroblastoma or ganglioneuroblastoma. They must not have had much treatment before this study. The trial team will check if each child is eligible to participate.
Conditions
Ganglioneuroblastoma, Nodular, Neuroblastoma
The study team makes the final call on eligibility.
What happens in the study
Participants will be assigned by chance to one of two groups. One group will receive standard treatment, while the other will get the same treatment plus dinutuximab. Everyone will also have tests like blood draws and scans to monitor their health. Depending on how well the treatment works, patients may go through additional therapies, including stem cell transplant and radiation.
Where
This trial is running at 156 locations in the United States. 154 of them are currently recruiting.
AdventHealth Orlando
Orlando, Florida
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois
Advocate Children's Hospital-Park Ridge
Park Ridge, Illinois
Albany Medical Center
Albany, New York
Alfred I duPont Hospital for Children
Wilmington, Delaware
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada
Arkansas Children's Hospital
Little Rock, Arkansas
Arnold Palmer Hospital for Children
Orlando, Florida
The first 8 of 156 sites are listed here. The registry record has the full list.