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RECRUITING Phase 3

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

NCT03126916 · View on ClinicalTrials.gov ↗

Study Summary

This phase III trial studies iobenguane I-131 or lorlatinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma. Radioactive drugs, such as iobenguane I-131, may carry radiation directly to tumor cells and not harm normal cells. Lorlatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or lorlatinib and standard therapy may work better compared to lorlatinib and standard therapy alone in treating younger patients with neuroblastoma or ganglioneuroblastoma.

Interventions

  • DRUG Carboplatin
  • PROCEDURE Biospecimen Collection
  • DRUG Busulfan
  • PROCEDURE Bone Marrow Aspiration and Biopsy
  • PROCEDURE Autologous Hematopoietic Stem Cell Transplantation

Study Locations (20)

California

  • Kaiser Permanente Downey Medical Center — Downey
  • Loma Linda University Medical Center — Loma Linda
  • Children's Hospital Los Angeles — Los Angeles
  • Mattel Children's Hospital UCLA — Los Angeles
  • Valley Children's Hospital — Madera
  • Kaiser Permanente-Oakland — Oakland
  • Children's Hospital of Orange County — Orange
  • Lucile Packard Children's Hospital Stanford University — Palo Alto
  • University of California Davis Comprehensive Cancer Center — Sacramento
  • Rady Children's Hospital - San Diego — San Diego
  • Naval Medical Center -San Diego — San Diego
  • UCSF Medical Center-Mission Bay — San Francisco

Colorado

  • Children's Hospital Colorado — Aurora
  • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver

Connecticut

  • Connecticut Children's Medical Center — Hartford
  • Yale University — New Haven

Alabama

  • Children's Hospital of Alabama — Birmingham

Arizona

  • Phoenix Childrens Hospital — Phoenix

Arkansas

  • Arkansas Children's Hospital — Little Rock

Delaware

  • Alfred I duPont Hospital for Children — Wilmington

Trial Details

FieldValue
Enrollment Target 750 participants
Start Date 2018-05-14
Est. Completion 2030-09-30
Phase Phase 3

Sponsor

Children's Oncology Group

318 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03126916

The ClinicalTrials.gov registry entry for NCT03126916 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 750 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Oncology Group, which has 318 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Neuroblastoma appearing as the primary indexed condition, and to 5 interventions — of which Carboplatin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03126916 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Colorado, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03126916 about?

NCT03126916 is a clinical study titled "Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)". This phase III trial studies iobenguane I-131 or lorlatinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma. Radioactive drugs, such as iobenguane I-131, may carry radiation directly to tumor cells and not harm normal cells. Lorl...

What is the current status of trial NCT03126916?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 750 participants. The study started on 2018-05-14. Estimated completion is 2030-09-30.

What conditions does trial NCT03126916 study?

This clinical trial studies the following conditions: Neuroblastoma, Ganglioneuroblastoma, Ganglioneuroblastoma, Nodular. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03126916?

The interventions under investigation include: Carboplatin (DRUG), Biospecimen Collection (PROCEDURE), Busulfan (DRUG), Bone Marrow Aspiration and Biopsy (PROCEDURE), Autologous Hematopoietic Stem Cell Transplantation (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03126916?

This trial is sponsored by Children's Oncology Group, which has 318 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03126916 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial