Dinutuximab with Chemotherapy, Surgery, and Stem Cell Transplant for High-Risk Neuroblastoma
This study is looking at whether adding dinutuximab to standard treatments improves outcomes for children and young adults (up to 30 years old) with newly diagnosed high-risk neuroblastoma or ganglioneuroblastoma (a type of tumor that starts in nerve cells). Dinutuximab is a type of immunotherapy that works by helping your immune system find and kill cancer cells. Participants will receive dinutuximab along with chemotherapy, surgery to remove the tumor, radiation, and a stem cell transplant. The main goal is to see if this combination improves how long patients live without their cancer returning or getting worse (event-free survival), measured up to 3 years. To join, you must have a confirmed diagnosis of high-risk neuroblastoma and have completed specific molecular testing.
- Study design
- This interventional study plans to enroll 478 participants. It is comparing treatment that includes early chemoimmunotherapy during induction with treatment that does not.
- What's involved
- You would undergo blood and urine sample collection, bone marrow aspiration, and bone marrow biopsy. You would also receive carboplatin and cisplatin intravenously (IV).
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, event-free survival, is measured up to 3 years, suggesting follow-up for at least this duration.
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NCT06172296
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
Recruiting
PHASE3Up to 30InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~478 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:Biospecimen CollectionBone Marrow AspirationBone Marrow BiopsyCarboplatinCisplatinComputed Tomography
At a glance
Recruiting sites
175 of 179 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Event free survival (EFS)
Measured over Up to 3 years
Conditions
Where it's being run
179 sites across 62 statesCalifornia16
Texas13
Florida12
New York10
Illinois7
North Carolina7
Ohio7
New Jersey6
Study leadership
- Sara M Federico · PRINCIPAL_INVESTIGATOR · Children's Oncology Group
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Patients must be enrolled on APEC14B1 and have consented to testing through the Molecular Characterization Initiative (MCI), prior to enrollment on ANBL2131
≤ 30 years at the time of initial diagnosis with high-risk disease
\* Must have a diagnosis of neuroblastoma (NBL) or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamines
Newly diagnosed, high risk neuroblastoma (HRNBL) defined as one of the following:
Any age with International Neuroblastoma Risk Group (INRG) Stage L2, MS, or M and MYCN amplification
Age ≥ 547 days and INRG stage M regardless of biologic features (clinical MYCN testing not required prior to enrollment)
Any age initially diagnosed with INRG Stage L1 MYCN amplified NBL who have progressed to stage M without systemic chemotherapy
Age ≥ 547 days of age initially diagnosed with INRG Stage L1, L2, or MS who have progressed to stage M without systemic chemotherapy (clinical MYCN testing not required prior to enrollment)
Patients must have a body surface area (BSA) ≥ 0.25 m\^2
No prior anti-cancer therapy except as outlined below:
Patients initially recognized to have high-risk disease treated with topotecan/cyclophosphamide initiated on an emergent basis and within allowed timing, and with consent
Patients observed or treated with a single cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (e.g., as per ANBL0531, ANBL1232 or similar) for what initially appeared to be non-high-risk disease but subsequently found to meet the criteria
Patients who received localized emergency radiation to sites of life threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis
Human immunodeficiency virus (HIV) -infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
A serum creatinine based on age/sex as follows:
1 month to \< 6 months: Male 0.4 mg/dL and female 0.4mg/dL
6 months to \< 1 year: Male 0.5 mg/dL and female 0.5 mg/dL
1 to \< 2 years: Male 0.6 mg/dL and female 0.6 mg/dL
2 to \< 6 years: Male 0.8 mg/dL and female 0.8 mg/dL
6 to \< 10 years: Male 1 mg/dL and female 1 mg/dL
10 to \< 13 years: Male 1.2 mg/dL and female 1.2 mg/dL
13 to \< 16 years: Male 1.5 mg/dL and female 1.4 mg/dL
≥ 16 years: Male 1.7 mg/dL and female 1.4 mg/dL
The threshold creatinine values were derived from the Schwartz formula for estimating glomerular filtration rate (GFR) utilizing child length and stature data published by the Centers for Disease Control (CDC)
or a 24-hour urine creatinine clearance ≥ 70 mL/min/1.73 m\^2 or
or a GFR ≥ 70 mL/min/1.73 m\^2. GFR must be performed using direct measurement with a nuclear blood sampling method or direct small molecule clearance method (iothalamate or other molecule per institutional standard)
Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility
Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age
Serum glutamic pyruvic transaminase (SGPT) (Alanine aminotransferase \[ALT\]) ≤ 10 x ULN\*
Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L
\* Shortening fraction of ≥ 27% by echocardiogram, or
Ejection fraction of ≥ 50% by echocardiogram or radionuclide angiogram
Ability to tolerate Peripheral Blood Stem Cell (PBSC) collection:
Exclusion
Patients who are 365-546 days of age with INRG Stage M and MYCN non-amplified NBL, irrespective of additional biologic features
Patients ≥ 547 days of age with INRG Stage L2, MYCN non-amplified NBL, regardless of additional biologic features
Patients with known bone marrow failure syndromes
Patients on chronic immunosuppressive medications (e.g., tacrolimus, cyclosporine, corticosteroids) for reasons other than prevention/treatment of allergic reactions and adrenal replacement therapy are not eligible. Topical and inhaled corticosteroids are acceptable
Patients with a primary immunodeficiency syndrome who require ongoing immune globulin replacement therapy
Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required prior to enrollment for female patients of childbearing potential
Lactating females who plan to breastfeed their infants
Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
All patients and/or their parents or legal guardians must sign a written informed consent
All institutional, food and drug administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
What this trial measures
- Event free survival (EFS)Up to 3 years
EFS time is calculated from time of randomization to Arms A or B to first episode of disease relapse or progression, second malignancy, or death, or until last contact if no event has occurred.