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4XW",{"type":57,"coordinates":1842},[1843,1844],-3.18,51.48,{"lat":1844,"lon":1843},{"facility":1847,"status":50,"city":1848,"state":40,"zip":1849,"country":1808,"countryCode":1809,"cosmosGeoPoint":1850,"geoPoint":1854,"contacts":40},"Western General Hospital, Lothian Health Board","Edinburgh","EH4 2XU",{"type":57,"coordinates":1851},[1852,1853],-3.19648,55.95206,{"lat":1853,"lon":1852},{"facility":1856,"status":50,"city":1857,"state":40,"zip":1858,"country":1808,"countryCode":1809,"cosmosGeoPoint":1859,"geoPoint":1863,"contacts":40},"Gloucestershire Royal Hospital","Gloucester","GL1 3NN",{"type":57,"coordinates":1860},[1861,1862],-2.2431,51.86568,{"lat":1862,"lon":1861},{"facility":1865,"status":50,"city":1866,"state":40,"zip":1867,"country":1808,"countryCode":1809,"cosmosGeoPoint":1868,"geoPoint":1872,"contacts":40},"Harrogate District Hospital","Harrogate","HG2 7SX",{"type":57,"coordinates":1869},[1870,1871],-1.5373,53.99078,{"lat":1871,"lon":1870},{"facility":1874,"status":50,"city":1875,"state":40,"zip":1876,"country":1808,"countryCode":1809,"cosmosGeoPoint":1877,"geoPoint":1881,"contacts":40},"Leicester Royal Infirmary","Leicester","LE1 5WW",{"type":57,"coordinates":1878},[1879,1880],-1.13169,52.6386,{"lat":1880,"lon":1879},{"facility":1883,"status":50,"city":1884,"state":40,"zip":1885,"country":1808,"countryCode":1809,"cosmosGeoPoint":1886,"geoPoint":1890,"contacts":40},"The Clatterbridge Cancer Center NHS Foundation Trust","Liverpool","L7 8YA",{"type":57,"coordinates":1887},[1888,1889],-2.97794,53.41058,{"lat":1889,"lon":1888},{"facility":1892,"status":50,"city":1893,"state":40,"zip":1894,"country":1808,"countryCode":1809,"cosmosGeoPoint":1895,"geoPoint":1899,"contacts":40},"University College Hospital","London","NW1 2PG",{"type":57,"coordinates":1896},[1897,1898],-0.12574,51.50853,{"lat":1898,"lon":1897},{"facility":1901,"status":50,"city":1893,"state":40,"zip":1902,"country":1808,"countryCode":1809,"cosmosGeoPoint":1903,"geoPoint":1905,"contacts":40},"Guy's Hospital","SE1 9RT",{"type":57,"coordinates":1904},[1897,1898],{"lat":1898,"lon":1897},{"facility":1907,"status":50,"city":1908,"state":40,"zip":1909,"country":1808,"countryCode":1809,"cosmosGeoPoint":1910,"geoPoint":1914,"contacts":40},"Genesis Care, Oxford","Oxford","OX4 6LB",{"type":57,"coordinates":1911},[1912,1913],-1.25596,51.75222,{"lat":1913,"lon":1912},{"facility":1916,"status":50,"city":1917,"state":40,"zip":1918,"country":1808,"countryCode":1809,"cosmosGeoPoint":1919,"geoPoint":1923,"contacts":40},"Genesis Care, Windsor","Windsor","SL4 3HD",{"type":57,"coordinates":1920},[1921,1922],-0.6,51.48333,{"lat":1922,"lon":1921},{"type":1925,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100552903","phase-3-study-of-navtemadlin-add-on-to-ruxolitinib-in-jak-inhibitor-nave-patients-with-myelofibrosis-who-have-a-suboptimal-response-to-ruxolitinib-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":1937,"type":1938},600,"ESTIMATED","INTERVENTIONAL",[1941],"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.",[1944,1945,1946,1947,1948],"Myelofibrosis","Post-PV MF","Post-ET Myelofibrosis","Primary Myelofibrosis","MF",[24,28,34,1932,1950,1951,1952],"TP53","Suboptimal response","Sub-optimal response","2025-09-22",{"date":1955,"type":1956},"2025-09-25","ACTUAL",{"date":1958,"type":1956},"2024-06-03",{"date":1960,"type":1938},"2028-12-31",{"name":5,"class":6},215]