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NCT03126916 · ClinicalTrials.gov registry record · Phase 3
Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)
A Phase 3 study of Neuroblastoma and Ganglioneuroblastoma, sponsored by Children's Oncology Group.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 750
- Enrollment target
- 20
- Study locations
NCT03126916: Recruiting Phase 3 study of Neuroblastoma and Ganglioneuroblastoma, sponsored by Children's Oncology Group.
NCT03126916 is a Phase 3 study of Neuroblastoma and Ganglioneuroblastoma that is actively recruiting participants, run by Children's Oncology Group. The registered enrollment target is 750 participants, above the 231-participant average among 94 other Neuroblastoma trials with a reported enrollment target (225% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03126916, a Phase 3 study of Neuroblastoma and Ganglioneuroblastoma, is actively recruiting participants, sponsored by Children's Oncology Group.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 750 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
EFS time is calculated from date of randomization or assignment to first episode of disease relapse or progression, second malignancy, or death, or until last contact if no event has occurred.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 750 participants |
| Start Date | 2018-05-14 |
| Est. Completion | 2030-09-30 |
| Phase | Phase 3 |
What NCT03126916 shows while recruiting
NCT03126916 is an interventional study that assigns participants to a tested intervention. The registered 750 participants enrollment target is mid-sized for trials with a published cap, above the 231-participant average among 94 other Neuroblastoma trials with a reported enrollment target (225% higher).
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.
NCT03126916 names 20 study sites across 7 states, led by California, Colorado, Connecticut.
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.
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).
Who is sponsoring clinical trial NCT03126916?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Neuroblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03126916's enrollment target sits among peer trials
750 7th of 94 higher than 88 of 94 other Neuroblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neuroblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
RECRUITING · Phase 3
-
Response and Biology-Based Risk Factor-Guided Therapy in Treating Younger Patients With Non-high Risk Neuroblastoma
ACTIVE NOT RECRUITING · Phase 3
-
A Web-Based Stem Cell Transplant Support System or Standard Care in Young Patients Undergoing Stem Cell Transplant and Their Families
COMPLETED · Phase 3
-
Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With Neuroblastoma
COMPLETED · Phase 3
-
Surgery in Treating Children With Neuroblastoma
COMPLETED · Phase 3
-
MCT for the Harvard/UCSF ROBIN Center
RECRUITING · NA
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