Patients Between the Ages of 12 Months to 21 Years With Newly-Diagnosed High-Risk Neuroblastoma Will Receive Children's Oncology Group (COG) Type Recommended Therapy With the Addition of Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) to Induction Cycles 1-5

Sponsor
Shaare Zedek Medical Center
Study ID
NCT07537400
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Months - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Naxitamab — DRUG
    Naxitamab and GM-CSF administered with COG type induction chemotherapy.

Study Details

This clinical trial will evaluate the safety of chemoimmunotherapy with Naxitamab and COG-type induction chemotherapy in newly-diagnosed patients with high-risk neuroblastoma. We aim to recruit 10 patients over the next 2 years.

Key Dates

First listed
Apr 17, 2026
Start date
Jun 23, 2026
Status verified
Sep 2026
Primary completion
Jun 30, 2028
Completion
Apr 30, 2032

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Naxitamab and GM-CSF
    All enrolled patients receive Naxitamab and GM-CSF in combination with induction therapy for newly-diagnosed high-risk neuroblastoma

Primary Outcome Measure

Evaluate the safety of chemoimmunotherapy with Naxitamab and COG-type induction chemotherapy in newly diagnosed patients with high-risk neuroblastoma [ Time Frame: Post 2nd course, and post 5th course of chemoimmunotherapy (therapy lasts approximately 4 and a half months) ]

Central Contacts

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