Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Combined With Isotretinoin for Maintenance Treatment of Patients With High-Risk Neuroblastoma in First Complete Response.

Sponsor
SciClone Pharmaceuticals
Study ID
NCT06047535
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Months - N/A
Healthy Volunteers
Not accepted

Interventions

  • Naxitamab — DRUG
    Naxitamab + GM-CSF: Cycles 1-5: Patients will receive naxitamab IV at 3 mg/kg/infusion on Day 1, 3 and 5 and GM-CSF sc at 5 µg/kg/day on Days -4 to 0 and at 10 µg/kg/day on Days 1-5 for 5 cycles. Isotretinoin: Cycles 3-8: Patients will receive isotretinoin PO at 160 mg/m2/day divided into two daily doses on Days 15-28 for 6 cycles.

Study Details

This is a single-arm, multicenter clinical trial conducted in patients ≥ 12 months of age with high-risk neuroblastoma in first complete response. 62 patients will be enrolled to receive naxitamab + GM-CSF in combination with isotretinoin. In line with post-consolidation maintenance treatment of high-risk neuroblastoma, this trial will include patients with high-risk neuroblastoma in first complete response. Patients must have completed a multimodal frontline regimen (induction and consolidation) and have achieved complete response (positive bone marrow minimal residual disease as assessed by RTqPCR is allowed) following the multi agent induction and consolidation therapy.

Key Dates

First listed
Sep 21, 2023
Start date
Oct 31, 2023
Status verified
Sep 2023
Primary completion
Jun 15, 2027
Completion
Aug 15, 2027

Study Design

Enrollment
62 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Primary Outcome Measure

2-year progression free survival [ Time Frame: 2 years ]

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