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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 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.
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.
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 750 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 231-participant average among 94 other Neuroblastoma trials with a reported enrollment target (225% higher). The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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