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Hospital","Cambridge","CB2 0QQ",{"type":56,"coordinates":1816},[1817,1818],0.11667,52.2,{"lat":1818,"lon":1817},{"facility":1821,"status":50,"city":1822,"state":40,"zip":1823,"country":1792,"cosmosGeoPoint":1824,"geoPoint":1828,"contacts":40},"University Hospital of Wales","Cardiff","CF14 4XW",{"type":56,"coordinates":1825},[1826,1827],-3.18,51.48,{"lat":1827,"lon":1826},{"facility":1830,"status":50,"city":1831,"state":40,"zip":1832,"country":1792,"cosmosGeoPoint":1833,"geoPoint":1837,"contacts":40},"Western General Hospital, Lothian Health Board","Edinburgh","EH4 2XU",{"type":56,"coordinates":1834},[1835,1836],-3.19648,55.95206,{"lat":1836,"lon":1835},{"facility":1839,"status":50,"city":1840,"state":40,"zip":1841,"country":1792,"cosmosGeoPoint":1842,"geoPoint":1846,"contacts":40},"Gloucestershire Royal Hospital","Gloucester","GL1 3NN",{"type":56,"coordinates":1843},[1844,1845],-2.2431,51.86568,{"lat":1845,"lon":1844},{"facility":1848,"status":50,"city":1849,"state":40,"zip":1850,"country":1792,"cosmosGeoPoint":1851,"geoPoint":1855,"contacts":40},"Harrogate District Hospital","Harrogate","HG2 7SX",{"type":56,"coordinates":1852},[1853,1854],-1.5373,53.99078,{"lat":1854,"lon":1853},{"facility":1857,"status":50,"city":1858,"state":40,"zip":1859,"country":1792,"cosmosGeoPoint":1860,"geoPoint":1864,"contacts":40},"Leicester Royal Infirmary","Leicester","LE1 5WW",{"type":56,"coordinates":1861},[1862,1863],-1.13169,52.6386,{"lat":1863,"lon":1862},{"facility":1866,"status":50,"city":1867,"state":40,"zip":1868,"country":1792,"cosmosGeoPoint":1869,"geoPoint":1873,"contacts":40},"The Clatterbridge Cancer Center NHS Foundation Trust","Liverpool","L7 8YA",{"type":56,"coordinates":1870},[1871,1872],-2.97794,53.41058,{"lat":1872,"lon":1871},{"facility":1875,"status":50,"city":1876,"state":40,"zip":1877,"country":1792,"cosmosGeoPoint":1878,"geoPoint":1882,"contacts":40},"University College Hospital","London","NW1 2PG",{"type":56,"coordinates":1879},[1880,1881],-0.12574,51.50853,{"lat":1881,"lon":1880},{"facility":1884,"status":50,"city":1876,"state":40,"zip":1885,"country":1792,"cosmosGeoPoint":1886,"geoPoint":1888,"contacts":40},"Guy's Hospital","SE1 9RT",{"type":56,"coordinates":1887},[1880,1881],{"lat":1881,"lon":1880},{"facility":1890,"status":50,"city":1891,"state":40,"zip":1892,"country":1792,"cosmosGeoPoint":1893,"geoPoint":1897,"contacts":40},"Genesis Care, Oxford","Oxford","OX4 6LB",{"type":56,"coordinates":1894},[1895,1896],-1.25596,51.75222,{"lat":1896,"lon":1895},{"facility":1899,"status":50,"city":1900,"state":40,"zip":1901,"country":1792,"cosmosGeoPoint":1902,"geoPoint":1906,"contacts":40},"Genesis Care, Windsor","Windsor","SL4 3HD",{"type":56,"coordinates":1903},[1904,1905],-0.6,51.48333,{"lat":1905,"lon":1904},{"type":1908,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100552903",false,"NCT06479135","Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib","A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib","POIESIS","Inclusion Criteria for Ruxolitinib Alone Period:\n\n* Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by the treating physician according to the World Health Organization (WHO) criteria\n* High, Intermediate-1, Intermediate-2 risk category International Prognosis System Score (IPSS)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* JAK-inhibitor treatment naive\n\nExclusion Criteria for Ruxolitinib Alone Period:\n\n* Prior Splenectomy\n* Splenic irradiation within 3 months prior to the first dose\n* Prior BCL-XL, BET, MDM2, PI3K, PIM, or XPO1 inhibitors therapy or p53-directed therapy\n* Eligible for Bone Marrow Transplant\n* Peripheral blood or bone marrow blast count ≥ 10 percent\n\nInclusion Criteria for Randomized Period:\n\n* PMF, post-PV MF, or post-ET MF that is TP53WT as assessed by central testing\n* ECOG performance status of 0 to 2\n* Treatment with a stable dose of ruxolitinib\n* Suboptimal response to run-in ruxolitinib treatment\n\nExclusion Criteria for Randomized Period:\n\n* Elevated white blood cell count that doubles (or more) during ruxolitinib treatment and exceeds 50 × 10\\^9\u002FL\n* Peripheral blood or bone marrow blast count ≥ 10 percent","ALL","18 Years",{"count":1919,"type":1920},600,"ESTIMATED","INTERVENTIONAL",[1923],"PHASE3","This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib treatment will provide more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone.\n\nSubjects will start by receiving ruxolitinib alone in the run-in period. Those who demostrate a suboptimal response from ruxolitinib alone will then be randomized 2:1 to receive navtemadlin or navtemadlin placebo as add-on treatment to their ongoing ruxolitinib. Randomized means that subjects will be assigned to a group by chance, like a flip of a coin. The study is blinded, meaning the subjects, doctors, central endpoint assessors and sponsor will not know which add on treatment (navtemadlin or navtemadlin placebo) the subject is receiving.",[1926,1927,1928,1929,1930],"Myelofibrosis","Post-PV MF","Post-ET Myelofibrosis","Primary Myelofibrosis","MF",[24,28,34,1914,1932,1933,1934],"TP53","Suboptimal response","Sub-optimal response","2025-09-22",{"date":1937,"type":1938},"2025-09-25","ACTUAL",{"date":1940,"type":1938},"2024-06-03",{"date":1942,"type":1920},"2028-12-31",{"name":5,"class":6},215]