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