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NCT06333899 · ClinicalTrials.gov registry record · Early Phase 1
Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion
A Early Phase 1 study of Glioblastoma and Glioblastoma Multiforme, sponsored by Nationwide Children's Hospital.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
- 18
- Study locations
NCT06333899 is a Early Phase 1 study of Glioblastoma and Glioblastoma Multiforme that is actively recruiting participants, run by Nationwide Children's Hospital. The registered enrollment target is 15 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (86% lower). The trial reports 18 study locations across 17 states.
The verdict
NCT06333899, a Early Phase 1 study of Glioblastoma and Glioblastoma Multiforme, is actively recruiting participants, sponsored by Nationwide Children's Hospital.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
- 18
- Study locations
Study Summary
The goal of this study is to determine the response of the study drug loratinib in treating children who are newly diagnosed high-grade glioma with a fusion in ALK or ROS1. It will also evaluate the safety of lorlatinib when given with chemotherapy or after radiation therapy.
Conditions Studied
Interventions
- DRUG Lorlatinib
- DRUG Lorlatinib with chemotherapy1
- DRUG Lorlatinib with chemotherapy 2
- DRUG Lorlatinib post Radiation
Study Locations (18)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Nationwide Children's Hospital - Columbus
Colorado
- Children's Hospital Colorado - Aurora
District of Columbia
- Children's National Medical Center - Washington D.C.
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Massachusetts
- Dana-Farber Cancer Institute - Boston
North Carolina
- Duke University Health System - Durham
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Texas
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-08-03 |
| Est. Completion | 2035-06-01 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06333899
The ClinicalTrials.gov registry entry for NCT06333899 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (86% lower). The listed sponsor is Nationwide Children's Hospital, which has 188 total studies on file at ClinicalTrials.gov.
The record links to 9 conditions, with Glioblastoma appearing as the primary indexed condition, and to 4 interventions - of which Lorlatinib is the first listed.
NCT06333899 reports 18 study locations spanning 17 distinct geographic areas - top geographies include Ohio, Colorado, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT06333899 about?
NCT06333899 is a clinical study titled "Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion". The goal of this study is to determine the response of the study drug loratinib in treating children who are newly diagnosed high-grade glioma with a fusion in ALK or ROS1. It will also evaluate the safety of lorlatinib when given with chemotherapy or after radiation therapy.
What is the current status of trial NCT06333899?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2025-08-03. Estimated completion is 2035-06-01.
What conditions does trial NCT06333899 study?
This clinical trial studies the following conditions: Glioblastoma, Glioblastoma Multiforme, High Grade Glioma, Anaplastic Astrocytoma, Diffuse Intrinsic Pontine Glioma.
What interventions are being tested in trial NCT06333899?
The interventions under investigation include: Lorlatinib (DRUG), Lorlatinib with chemotherapy1 (DRUG), Lorlatinib with chemotherapy 2 (DRUG), Lorlatinib post Radiation (DRUG).
Who is sponsoring clinical trial NCT06333899?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06333899 being conducted?
This trial has 18 study locations across Colorado, District of Columbia, Illinois, Massachusetts, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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