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ANBL2131: Dinutuximab and Chemotherapy for High-risk Neuroblastoma

About this study

High-risk neuroblastoma is usually treated with intense therapy including:

For about half of the children with high-risk neuroblastoma, their disease may worsen, spread, or relapse (come back) after treatment. New treatments are needed to improve the survival rate.

This study will test whether adding an FDA-approved medicine, dinutuximab, plus chemotherapy, to the beginning of treatment will help fight high-risk neuroblastoma better.

Dinutuximab is a type of medicine known as immunotherapy. Half of the patients will be randomly assigned to receive dinutuximab plus chemotherapy during the beginning of therapy. Half will receive chemotherapy alone. The survival rates of the 2 groups will be compared to determine which is the best treatment.

This study will also help doctors look for markers in the blood bone marrow and tumor that may help show which patients will respond to therapy in the future.

Eligibility overview

  • Neuroblastoma or ganglioneuroblastoma
  • Up to 30 years old
  • Already enrolled in the APEC14B1 clinical trial
  • Consent to DNA testing
  • No prior cancer therapy
  • Adequate organ function
     

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Overview

Full title:

ANBL2131, A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children with Newly Diagnosed High-risk Neuroblastoma

Study goal:

To find out whether adding dinutuximab with chemotherapy, early in treatment, treats high-risk neuroblastoma better than adding it later with chemotherapy.

Diagnosis:

Neuroblastoma or ganglioneuroblastoma

Age:

Up to 30 years old

Clinical trials categories:

Childhood Cancer Solid Tumors Neuroblastoma

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.

 

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