Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma

Conditions

• Neuroblastoma

Eligibility Criteria

Sex

ALL

Age

12 Months - 21 Years

Healthy Volunteers

Not accepted

Interventions

• Naxitamab — DRUG
  Naxitamab is a humanized (IgG1) anti-GD2 (hu3F8) monoclonal antibody for the treatment of neuroblastoma, osteosarcoma and other GD2-positive cancers. Naxitamab was granted accelerated approval by the FDA in 2020 as treatment (in combination with granulocyte-macrophage colony-stimulating factor - GM-CSF) for pediatric patients at least one year of age and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow demonstrating a partial response, minor response, or stable disease to prior therapy

Study Details

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.

Key Dates

Start date

Sep 14, 2022

Status verified

Jan 2026

Primary completion

Sep 30, 2029

Completion

Sep 30, 2036

Study Design

Enrollment

93 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: HRNB Newly diagnosed subjects
  5 cycles of standard of care induction + naxitimab Naxitimab on Days 1, 3, and 5 of each cycle

Primary Outcome Measure

Number of participants with Complete Response (CR) rate per 1993 INRC guidelines [ Time Frame: 6 to 12 months ]

Central Contacts

• BCC Enroll
  7175310003
  [email protected]

Locations (20)

Find similar trials in Birmingham, AL

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