Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma (NCT05489887)
A Phase II Study of Naxitamab Added to Induction Therapy for Subjects With Newly Diagnosed High-Risk Neuroblastoma
๐ฉบ Plain-English Summary (8th-Grade Level)
This is a prospective, multicenter clinical trial in subjects with newly diagnosed high-risk neuroblastoma to evaluate the efficacy and safety of administering naxitamab with standard induction therapy. The initial chemotherapy will include 5 cycles of multi-agent chemotherapy. Naxitamab will be added to all 5 Induction cycles. We hypothesize that the addition of anti-GD2 therapy to induction chemotherapy will result in improved end of induction responses and improved survival.
Who can join: Review the eligibility criteria below.
Location: University of Alabama/Children's of Alabama โ Birmingham, Alabama
Age range: 12 Months to 21 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (26 Sites)
Showing the first 25 of 26 sites.
- University of Alabama/Children's of Alabama โ Birmingham, Alabama
- Arkansas Children's Hospital โ Little Rock, Arkansas
- UCSF Benioff Children's Hospital Oakland โ Oakland, California
- Rady Children's Hospital โ San Diego, California
- Connecticut Children's Hospital โ Hartford, Connecticut
- University of Florida โ Gainesville, Florida
- Nicklaus Children's Hospital โ Miami, Florida
- Arnold Palmer Hospital for Children โ Orlando, Florida
- Augusta University Health โ Augusta, Georgia
- Kapiolani Medical Center for Women and Children โ Honolulu, Hawaii
- Norton Children's Research Institute/Affiliated with University of Louisville School of Medicine โ Louisville, Kentucky
- Children's Hospital and Clinics of Minnesota โ Minneapolis, Minnesota
- Cardinal Glennon Children's Hospital โ St Louis, Missouri
- Levine Children's Hospital โ Charlotte, North Carolina
- Duke University โ Durham, North Carolina
- Wake Forest University Health Sciences โ Winston-Salem, North Carolina
- Randall Children's Hospital โ Portland, Oregon
- Penn State Milton S. Hershey Medical Center and Children's Hospital โ Hershey, Pennsylvania
- Medical University of South Carolina โ Charleston, South Carolina
- Dell Children's Blood and Cancer Center โ Austin, Texas
- Virginia Commonwealth University โ Richmond, Virginia
- GRAACC Hospital โ Sรฃo Paulo, Sรฃo Paulo
- UHC Sainte-Justine โ Montreal, Quebec
- CHUQ โ Quรฉbec, Quebec
- CIUSSS de l'Estrie-CHUS โ Sherbrooke, Quebec
๐ Contact the Study Coordinator
Phone: (717) 531-0003
Email: BCCEnroll@pennstatehealth.psu.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Neuroblastoma
- Open-Label Study of 18F-mFBG for Imaging Neuroblastoma โ Los Angeles, California
- Neuroblastoma Precision Trial โ Los Angeles, California
- Neuroblastoma Maintenance Therapy Trial โ Birmingham, Alabama
- Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow โ Indianapolis, Indiana
- A Study of N9 Chemotherapy in Children With Neuroblastoma โ New York, New York
- A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma โ San Francisco, California
Explore by condition: All Neuroblastoma clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.