protocolSection identificationModule nctId: NCT06333899, orgStudyIdInfo id: CONNECT2111, briefTitle: Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2027-09-01, completionDateStruct date: 2034-09-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Nationwide Children's Hospital, class: OTHER, collaborators name: Pfizer, descriptionModule briefSummary: 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., conditionsModule conditions: High Grade Glioma, conditions: Diffuse Intrinsic Pontine Glioma, conditions: Anaplastic Astrocytoma, conditions: Infant Type Hemispheric Glioma, conditions: Glioblastoma, conditions: Glioblastoma Multiforme, conditions: WHO Grade III Glioma, conditions: WHO Grade IV Glioma, conditions: Diffuse Midline Glioma, H3K27-altered, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Feasibility, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Lorlatinib, interventions name: Lorlatinib with chemotherapy1, interventions name: Lorlatinib with chemotherapy 2, interventions name: Lorlatinib post Radiation, outcomesModule primaryOutcomes measure: Disease Control Rate, primaryOutcomes measure: Number of participants with lorlatinib-related adverse events as assessed by CTCAE v5.0, secondaryOutcomes measure: Objective Response Rate (ORR) in HGG, secondaryOutcomes measure: Overall Survival (OS) in HGG, secondaryOutcomes measure: Progression-Free Survival in HGG, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 21 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Children's Hospital Colorado, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Kathleen Dorris, MD, role: CONTACT, email: kathleen.dorris@childrenscolorado.org, geoPoint lat: 39.72943, lon: -104.83192, locations facility: Children's National Medical Center, city: Washington, state: District of Columbia, zip: 20010, country: United States, contacts name: Eugene Hwang, role: CONTACT, email: ehwang@childrensnational.org, geoPoint lat: 38.89511, lon: -77.03637, locations facility: Ann & Robert H. Lurie Children's Hospital of Chicago, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Ashley Plant, MD, role: CONTACT, email: Aplant@luriechildrens.org, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Dana-Farber Cancer Institute, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Susan Chi, role: CONTACT, email: Susan_chi@dfci.harvard.edu, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Duke University Health System, city: Durham, state: North Carolina, zip: 27708, country: United States, contacts name: David Ashley, MD, role: CONTACT, email: david.ashley@duke.edu, geoPoint lat: 35.99403, lon: -78.89862, locations facility: Cincinnati Children's Hospital Medical Center, city: Cincinnati, state: Ohio, zip: 45229, country: United States, contacts name: Peter de Blank, MD, role: CONTACT, email: Peter.deBlank@cchmc.org, geoPoint lat: 39.12713, lon: -84.51435, locations facility: Nationwide Children's Hospital, city: Columbus, state: Ohio, zip: 43235, country: United States, contacts name: Maryam Fouladi, MD, MSc, role: CONTACT, email: Maryam.fouladi@nationwidechildrens.org, geoPoint lat: 39.96118, lon: -82.99879, locations facility: Children's Hospital of Philadelphia, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Michael J Fisher, MD, role: CONTACT, email: fisherm@email.chop.edu, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Texas Children's Hospital, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Patricia Baxter, MD, role: CONTACT, email: pabaxter@txch.org, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Seattle Children's Hospital, city: Seattle, state: Washington, zip: 98105, country: United States, contacts name: Sarah Leary, role: CONTACT, email: sarah.leary@seattlechildrens.org, geoPoint lat: 47.60621, lon: -122.33207, locations facility: Sydney Children's Hospital, city: Randwick, state: New South Wales, zip: 2031, country: Australia, contacts name: David Ziegler, MD, role: CONTACT, email: d.ziegler@unsw.edu.au, geoPoint lat: -33.91439, lon: 151.24895, locations facility: Queensland Children's Hospital, city: South Brisbane, state: Queensland, zip: 4101, country: Australia, contacts name: Tim Hassall, MD, role: CONTACT, email: tim.hassall@health.qld.gov.au, geoPoint lat: -27.48034, lon: 153.02049, locations facility: Perth Children's Hospital, city: Perth, state: Western Australia, zip: 6000, country: Australia, contacts name: Nicholas G Gottardo, MBChB, role: CONTACT, email: nick.gottardo@health.wa.gov.au, geoPoint lat: -31.95224, lon: 115.8614, locations facility: The Hospital for Sick Children (SickKids), city: Toronto, state: Ontario, zip: M5G1X8, country: Canada, contacts name: Eric Bouffet, role: CONTACT, email: eric.bouffet@sickkids.ca, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Montreal Children's Hospital, city: Montréal, state: Quebec, zip: H4A3J1, country: Canada, contacts name: Genevieve Legault, MD, role: CONTACT, email: Genevieve.legault4@mcgill.ca, geoPoint lat: 45.50884, lon: -73.58781, locations facility: Hopp Children's Cancer Center at NCT Heidelberg (KiTZ), city: Heidelberg, state: Baden-Württemberg, zip: 69120, country: Germany, contacts name: Olaf Witt, MD, role: CONTACT, email: o.witt@kitz-heidelberg.de, geoPoint lat: 49.40768, lon: 8.69079, locations facility: Princess Máxima Center, city: Utrecht, zip: 3720, country: Netherlands, contacts name: Jasper van der Lugt, role: CONTACT, email: J.vanderLugt@prinsesmaximacentrum.nl, geoPoint lat: 52.09083, lon: 5.12222, hasResults: False