[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"post-essential-thrombocythaemia-myelofibrosis-pet-mf\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:post-essential-thrombocythaemia-myelofibrosis-pet-mf":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100575327",false,"NCT06770842","Ropeginterferon Alfa 2b Plus Ruxolitinib for Myelofibrosis","Safety and Efficacy of Ropeginterferon Alfa-2b in Combination With Ruxolitinib in Patients With Myelofibrosis Demonstrating Suboptimal Response to Ruxolitinib Monotherapy","Inclusion Criteria:\n\n* Willing and able to provide informed consent\n* Age ≥18 years\n* Diagnosis of Overt Myelofibrosis (primary, post-ET, or post-PV) per World Health Organization (WHO) 2022 diagnostic criteria\n* Intermediate-1, Intermediate-2, or high-risk disease by Dynamic International Prognostic Scoring System (DIPSS)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Platelet count ≥75 x 109\u002FL prior to dosing on Cycle 1 Day 1\n* Absolute neutrophil count ≥0.5 x 109\u002FL prior to dosing on Cycle 1 Day 1\n* Peripheral blast count ≤10% prior to dosing on Cycle 1 Day 1\n* Women of childbearing potential and fertile men must agree to use an approved method of contraception from screening until 30 days after the last dose of ropeginterferon and ruxolitinib.\n* Patients with suboptimal response to ruxolitinib as per one of the below:\n\n  i. Relapsed: Ruxolitinib treatment for ≥3 months with spleen regrowth, defined as \\\u003C10% SVR or \\\u003C30% decrease in spleen size from baseline, following an initial response\\* ii. Refractory: Ruxolitinib treatment for ≥3 months with \\\u003C10% SVR or \\\u003C30% decrease in spleen size from baseline.\n\n  \\* Response to ruxolitinib is defined as a ≥35% reduction in spleen volume from baseline, or a ≥50% reduction in spleen size for baseline spleen sizes \\>10 cm below left costal margin (LCM); a non-palpable spleen for baseline spleen sizes between 5-10 cm below LCM; or not eligible for spleen response for baseline spleen \\\u003C5 cm below LCM.\n\nExclusion Criteria:\n\nSubjects will not be eligible for participation if they meet any of the following exclusion criteria:\n\n* Prior or current use of interferon alfa (IFNα) preparations for MPN\n* Patients currently on other investigational therapy (ies)\n* Contraindications or hypersensitivity to IFNα preparations\n* History of organ and haematopoietic stem cell transplantation\n* History of splenectomy\n* Pregnant or lactating females, or females planning to become pregnant at any time during the study\n* Documented autoimmune disease at screening\n* Infection with human immunodeficiency virus (HIV)\n* Active and uncontrolled infections with hepatitis B virus (HBV) and hepatitis C virus (HCV). Please note that patients on antiviral therapy with undetectable HBV DNA and HCV RNA may be recruited.\n* Evidence of severe retinopathy including but not limited to macular degeneration, diabetic retinopathy and hypertensive retinopathy.\n* History of clinically significant neuropsychiatric conditions including but not limited to depression and epilepsy.\n* Clinically significant neuropsychiatric conditions including but not limited to depression and epilepsy.\n* Concurrent second active and non-stable malignancy (patients with a concurrent second active but stable malignancy, i.e., non-melanoma skin cancers, are eligible)\n* Evidence of alcohol or drug abuse within 6 months\n* Evidence at the time of Screening of significant renal or hepatic insufficiency (unless due to hemolysis) as defined by any of the following local lab parameters:\n\n  * Calculated glomerular filtration rate (GFR; using the Cockcroft-Gault equation) \\\u003C40 mL\u002Fmin or serum creatinine \\>1.5 x the local upper limit of normal\n  * Aspartate transaminase (AST) or alanine aminotransferase (ALT) ≥2.5 x the local upper limit of normal\n* Unwilling or unable to comply with the study protocol","ALL","18 Years",{"count":18,"type":19},20,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","In this open-label single arm phase 2 study, approximately 20 patients with MF demonstrating suboptimal response to ruxolitinib monotherapy will be enrolled. Patients will continue to receive ruxolitinib at a stable dose and ropeginterferon alfa 2b will be added to the regimen.",[25,26,27],"Primary Myelofibrosis (PMF)","Post Polycythemia Myelofibrosis (PPV MF)","Post Essential Thrombocythaemia Myelofibrosis (PET-MF)",[29,30,31,32],"Ruxolitinib","Ropeginterferon alfa 2b","Myelofibrosis","Ruxolitinib failiure","RECRUITING","2025-06-09",{"date":36,"type":37},"2025-06-11","ACTUAL",{"date":39,"type":37},"2025-03-01",{"date":41,"type":19},"2027-12",{"name":43,"class":44},"The University of Hong Kong","OTHER",""]