# Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)

> **NCT03126916** · PHASE3 · RECRUITING · sponsor: **Children's Oncology Group** · enrollment: 750 (estimated)

## Conditions studied

- Ganglioneuroblastoma
- Ganglioneuroblastoma, Nodular
- Neuroblastoma

## Interventions

- **PROCEDURE:** Autologous Hematopoietic Stem Cell Transplantation
- **PROCEDURE:** Biospecimen Collection
- **PROCEDURE:** Bone Marrow Aspiration and Biopsy
- **DRUG:** Busulfan
- **DRUG:** Carboplatin
- **DRUG:** Cisplatin
- **PROCEDURE:** Computed Tomography
- **DRUG:** Cyclophosphamide
- **DRUG:** Dexrazoxane Hydrochloride
- **BIOLOGICAL:** Dinutuximab
- **DRUG:** Doxorubicin Hydrochloride
- **PROCEDURE:** Echocardiography Test
- **DRUG:** Etoposide Phosphate
- **RADIATION:** External Beam Radiation Therapy
- **RADIATION:** Iobenguane I-123
- **RADIATION:** Iobenguane I-131
- **DRUG:** Isotretinoin
- **DRUG:** Lorlatinib
- **PROCEDURE:** Magnetic Resonance Imaging
- **DRUG:** Melphalan Hydrochloride

## Key facts

- **NCT ID:** NCT03126916
- **Lead sponsor:** Children's Oncology Group
- **Sponsor class:** NETWORK
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2018-05-14
- **Primary completion:** 2030-09-30
- **Final completion:** 2030-09-30
- **Target enrollment:** 750 (ESTIMATED)
- **Last updated:** 2026-02-27

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03126916

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03126916, "Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)". Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/clinical/NCT03126916. Licensed CC0.

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