Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow

Part of paid clinical trials in Gainesville, Florida.

Sponsor
Y-mAbs Therapeutics
Study ID
NCT03363373
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - N/A
Healthy Volunteers
Not accepted

Interventions

  • GM-CSF + Naxitamab — BIOLOGICAL
    Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) and Humanized IgG1 monoclonal GD2 antibody

Study Details

Children and adults diagnosed with high-risk neuroblastoma patients with primary refractory disease or incomplete response to salvage treatment in bone and/or bone marrow will be treated for up to 101 weeks with naxitamab and granulocyte-macrophage colony stimulating factor (GM-CSF). Patients will be followed for up to five years after first dose. Naxitamab, also known as hu3F8 is a humanised monoclonal antibody targeting GD2

Key Dates

Start date
Apr 3, 2018
Status verified
Feb 2026
Primary completion
Apr 30, 2026
Completion
Apr 30, 2028

Study Design

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

Arms

  • Experimental: GM-CSF + Naxitamab
    Each investigational cycle is started with 5 days of GM-CSF administered at 250 µg/m2/day in advance of the start of Naxitamab administration. GM-CSF is thereafter administered at 500 µg/m2/day on days 1 to 5. As standard treatment, Naxitamab is administered at 3 mg/kg/day on days 1, 3, and 5 totalling 9 mg/kg per cycle. Treatment cycles are repeated every 4 weeks until CR or PR followed by 5 additional cycles every 4 weeks (±1 week). Subsequent cycles are repeated every 8 weeks (±2 weeks) through 101 weeks from first infusion at the discretion of the investigator. After end of treatment patients will enter a long-term follow up for up to 3 years after end of treatment visit.

Primary Outcome Measure

Response rate during Naxitamab treatment [ Time Frame: 101 weeks ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32611-
University of ChicagoChicagoIllinois60637-
Riley Hospital for ChildrenIndianapolisIndiana46202-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Nationwide Children's HospitalColumbusOhio43205-
M.D. Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Gainesville, FL

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
University of Florida· Gainesville, FLUniversity of Chicago· Chicago, ILRiley Hospital for Children· Indianapolis, INMemorial Sloan Kettering Cancer Center· New York, NYNationwide Children's Hospital· Columbus, OHM.D. Anderson Cancer Center· Houston, TX

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