Actively Recruiting
Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma
Led by Giselle Sholler · Updated on 2026-02-03
93
Participants Needed
23
Research Sites
728 weeks
Total Duration
On this page
Sponsors
G
Giselle Sholler
Lead Sponsor
Y
Y-mAbs Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of neuroblastoma or ganglioneuroblastoma confirmed by histology or bone marrow tumor cells with elevated urinary catecholamines
- Newly diagnosed high-risk neuroblastoma defined by specific disease stages and biological features including MYCN amplification or unfavorable histology
- Age greater than 12 months and up to 21 years at diagnosis
- Adequate heart function: shortening fraction ≥ 27% or ejection fraction ≥ 50%
- Adequate liver function: total bilirubin ≤ 1.5 x upper limit of normal and ALT < 5 x upper limit of normal
- Adequate kidney function: estimated glomerular filtration rate ≥ 70 mL/min/1.73 m2
- Negative pregnancy test for females of childbearing potential (≥ 13 years or after menses onset)
- Willingness of post-pubertal males and females to use effective contraception during and 6 months after treatment
- Signed informed consent from participant and/or legal guardian
You will not qualify if you...
- Age less than 1 year
- Subjects aged 12-18 months with Stage M disease and all Stage L2 subjects with favorable biology are not eligible
- Prior systemic therapy except localized emergency radiation or no more than one cycle of chemotherapy
- Immunosuppressive treatment (except topical, inhaled, or short-term steroids) within 4 weeks before enrollment
- Poor lung function with symptoms or oxygen requirement, pulse oximetry < 94%, or abnormal pulmonary tests
- Pregnancy or breastfeeding
- Receiving any other investigational drug concurrently
- Any medical condition likely to interfere with study participation or result interpretation, including malabsorption, mental illness, or substance abuse
- Significant ongoing serious medical problems unrelated to cancer or treatment that may increase treatment risks or interfere with study drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 23 locations
1
University of Alabama/Children's of Alabama
Birmingham, Alabama, United States, 35201
Actively Recruiting
2
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Actively Recruiting
3
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609
Actively Recruiting
4
Rady Children's Hospital
San Diego, California, United States, 92123
Actively Recruiting
5
Connecticut Children's Hospital
Hartford, Connecticut, United States, 06106
Actively Recruiting
6
University of Florida
Gainesville, Florida, United States, 32611
Actively Recruiting
7
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
Actively Recruiting
8
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
Actively Recruiting
9
Augusta University Health
Augusta, Georgia, United States, 30912
Actively Recruiting
10
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96813
Actively Recruiting
11
Norton Children's Research Institute/Affiliated with University of Louisville School of Medicine
Louisville, Kentucky, United States, 40202
Actively Recruiting
12
Children's Hospital and Clinics of Minnesota
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
13
Cardinal Glennon Children's Hospital
St Louis, Missouri, United States, 63104
Actively Recruiting
14
Levine Children's Hospital
Charlotte, North Carolina, United States, 28204
Actively Recruiting
15
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Withdrawn
16
Randall Children's Hospital
Portland, Oregon, United States, 97227
Actively Recruiting
17
Penn State Milton S. Hershey Medical Center and Children's Hospital
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
18
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
19
Dell Children's Blood and Cancer Center
Austin, Texas, United States, 78723
Actively Recruiting
20
Virginia Commonwealth University
Richmond, Virginia, United States, 23284
Actively Recruiting
21
UHC Sainte-Justine
Montreal, Quebec, Canada, QC H3S 2G4
Actively Recruiting
22
CHUQ
Québec, Quebec, Canada, QC G1V 4W6
Actively Recruiting
23
CIUSSS de l'Estrie-CHUS
Sherbrooke, Quebec, Canada, QC J1H 5H3
Actively Recruiting
Research Team
B
BCC Enroll
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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