[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"post-polycythemia-myelofibrosis-ppv-mf\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:post-polycythemia-myelofibrosis-ppv-mf":21},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":17,"phases":4,"briefSummary":18,"conditions":19,"keywords":27,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":40,"locationsCount":4},"100419739","managed-access-programs-for-inc424-ruxolitinib-100419739",false,"NCT04745637","Managed Access Programs for INC424, Ruxolitinib","Inclusion criteria\n\n1. An independent request was received from a licensed physician.\n2. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.\n3. The patient is not eligible or able to enroll in a clinical trial or continue participation in such trial.\n4. There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.\n5. The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).\n6. Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.\n7. Managed Access provision is allowed per local laws\u002Fregulations.","ALL","2 Years","EXPANDED_ACCESS","The purpose of this registration is to list Managed Access Programs (MAPs) related to INC424, Ruxolitinib",[20,21,22,23,24,25,26],"Primary Myelofibrosis (PMF)","Post Polycythemia Myelofibrosis (PPV MF)","Thrombocythemia Myelofibrosis (PET-MF)","Severe\u002FVery Severe COVID-19 Illness","Polycythemia Vera (PV)","Steroid Refractory Acute Graft Versus Host Disease (SR aGVHD)","Steroid Refractory Chronic Graft Versus Host Disease (SR cGVHD)",[28,29,20,21,22,30,24,31,32,33,34],"MAP","Manage Access Program","Severe\u002Fvery severe COVID-19 illness","Steroid refractory acute Graft versus Host Disease (SR aGVHD)","Steroid refractory chronic Graft versus Host Disease (SR cGVHD)","INC424","Ruxolitinib","AVAILABLE","2025-11-14",{"date":38,"type":39},"2025-11-18","ACTUAL",{"name":41,"class":42},"Novartis Pharmaceuticals","INDUSTRY",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":15,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100575327","phase-2-ropeginterferon-alfa-2b-plus-ruxolitinib-for-myelofibrosis-100575327","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","18 Years",{"count":52,"type":53},20,"ESTIMATED","INTERVENTIONAL",[56],"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.",[20,21,59],"Post Essential Thrombocythaemia Myelofibrosis (PET-MF)",[34,61,62,63],"Ropeginterferon alfa 2b","Myelofibrosis","Ruxolitinib failiure","RECRUITING","2025-06-09",{"date":67,"type":39},"2025-06-11",{"date":69,"type":39},"2025-03-01",{"date":71,"type":53},"2027-12",{"name":73,"class":74},"The University of Hong Kong","OTHER",1]