[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"post-et-myelofibrosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:post-et-myelofibrosis":75},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"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":19,"type":20},600,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28,29,30],"Myelofibrosis","Post-PV MF","Post-ET Myelofibrosis","Primary Myelofibrosis","MF",[32,33,34,14,35,36,37],"Navtemadlin","KRT-232","Ruxolitinib","TP53","Suboptimal response","Sub-optimal response","RECRUITING","2025-09-22",{"date":41,"type":42},"2025-09-25","ACTUAL",{"date":44,"type":42},"2024-06-03",{"date":46,"type":20},"2028-12-31",{"name":48,"class":49},"Kartos Therapeutics, Inc.","INDUSTRY",215,{"id":52,"slug":4,"hasResults":10,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100460813","NCT05280509","Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib","An Open-Label, Multicenter, Phase 1b\u002F2 Study of the Safety and Efficacy of TL-895 Combined With Ruxolitinib in Janus-associated Kinase Inhibitor (JAKi) Treatment-Naïve Myelofibrosis (MF) Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib","Inclusion Criteria:\n\nSubjects with suboptimal response to ruxolitinib:\n\n* Treatment with at a stable dose of ruxolitinib prior to study entry\n* Subjects ≥ 18 years of age and able to provide informed consent.\n* Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) criteria\n* High-risk, intermediate-2 risk, or intermediate-1 risk, defined by Dynamic International Prognostic System (DIPSS)\n* Palpable spleen measuring ≥ 5 cm below the left lower coastal margin (LLCM) or spleen volume of ≥ 450 cm3 by MRI or CT scan assessment\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* Adequate hematological, hepatic, \\& renal function.\n\nExclusion Criteria:\n\nTreatment-naive subjects:\n\n* Prior treatment with any JAKi\n\nSubjects with suboptimal response to ruxolitinib:\n\n* Documented disease progression while on ruxolitinib treatment\n\nAll subjects:\n\n* Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment\n* Prior treatment with a BTK or BMX inhibitor",{"count":58,"type":20},70,[60,61],"PHASE1","PHASE2","This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must have MF (PMF, Post PV MF, or Post ET MF) who are JAKi treatment-naïve or those who have a suboptimal response to ruxolitinib.",[26,29,27,28],[26],"2023-02-16",{"date":67,"type":42},"2023-02-21",{"date":69,"type":42},"2022-06-09",{"date":71,"type":20},"2027-04",{"name":73,"class":49},"Telios Pharma, Inc.",19,""]