[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551233":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":37,"centralContacts":45,"locations":55,"responsibleParty":89,"collaborators":30,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":30,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":30,"enrollmentInfo":100,"targetDuration":30,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":30,"overallStatus":58,"whyStopped":30,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Chengdu Zenitar Biomedical Technology Co., Ltd","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"low dose group","EXPERIMENTAL","Flonoltinib 50mg",[13],"Drug: Flonoltinib 50mg",{"label":15,"type":10,"description":16,"interventionNames":17},"high dose group","Flonoltinib 100mg",[18],"Drug: Flonoltinib 100mg",{"label":20,"type":21,"description":22,"interventionNames":23},"control group","ACTIVE_COMPARATOR","Ruxolitinib",[24],"Drug: Ruxolitinib",[26,31,34],{"type":27,"name":11,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Flonoltinib 50mg, QD",[9],null,{"type":27,"name":16,"description":32,"armGroupLabels":33,"otherNames":30},"Flonoltinib 100mg, QD",[15],{"type":27,"name":22,"description":35,"armGroupLabels":36,"otherNames":30},"For patients with platelet counts between 100×10\\^9\u002FL and 200×10\\^9\u002FL, the recommended starting dose is 15 mg twice daily (bid). For patients with platelet counts \\>200×10\\^9\u002FL, the recommended starting dose is 20 mg bid. For patients with platelet counts between 50×10\\^9\u002FL and \\\u003C100×10\\^9\u002FL, the recommended maximum starting dose is 5 mg bid.",[20],[38,42],{"name":39,"affiliation":40,"role":41},"Zhijian Xiao, Doctor","Hematology Hospital, Chinese Academy of Medical Sciences","PRINCIPAL_INVESTIGATOR",{"name":43,"affiliation":44,"role":41},"Ting Niu, Doctor","West China Hospital",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":30,"email":50},"Liangkun Sun","CONTACT","15885742617","liangkunsun@zenitar.cn",{"name":52,"role":48,"phone":53,"phoneExt":30,"email":54},"Zheng Jiang","19048075294","zhengjiang@zenitar.cn",[56,75],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"West China Hospital Sichuan University","RECRUITING","Chengdu","Sichuan","610000","China","CN",{"type":65,"coordinates":66},"Point",[67,68],104.06667,30.66667,{"lat":68,"lon":67},[71],{"name":72,"role":48,"phone":73,"phoneExt":30,"email":74},"JingZe Zuo","028-85422654","huaxilunli@163.com",{"facility":40,"status":58,"city":76,"state":77,"zip":78,"country":62,"countryCode":63,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Tianjin","Tianjin Municipality","300052",{"type":65,"coordinates":80},[81,82],117.17667,39.14222,{"lat":82,"lon":81},[85],{"name":86,"role":48,"phone":87,"phoneExt":30,"email":88},"Qirou Wang, Doctor","022-23909095","ec@ihcams.ac.cn",{"type":90,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100551233","phase-2-a-phase-ii-clinical-trial-of-flonoltinib-maleate-tablet-in-intermediate-high-risk-myelofibrosis-100551233",false,"NCT06457425","A Phase II Clinical Trial of Flonoltinib Maleate Tablet in Intermediate-High Risk Myelofibrosis","An Open-Label, Positive Drug-Controlled, Parallel, Multicenter Phase II Clinical Trial of the Efficacy, Safety, and Pharmacokinetics of Flonoltinib Maleate Tablets in Patients With Intermediate to High-Risk Myelofibrosis","Inclusion Criteria:\n\n1. Age ≥ 18 years, no gender restrictions;\n2. Diagnosed with primary myelofibrosis (PMF) according to WHO criteria (2016 edition) or post-polycythemia vera myelofibrosis (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF) according to IWG-MRT criteria;\n3. Evaluated as intermediate-2 or high-risk myelofibrosis according to the Dynamic International Prognostic Scoring System (DIPSS) risk classification;\n4. Expected survival ≥ 24 weeks;\n5. ECOG score of 0-2;\n6. Splenomegaly: palpable spleen edge reaching or exceeding 5 cm below the costal margin (distance from the intersection of the left midclavicular line and the left costal margin to the farthest point of the spleen); or not palpable due to body habitus (obesity) but confirmed by magnetic resonance imaging (MRI ) (or CT scan if necessary) at screening with spleen volume ≥ 450 cm³;\n7. Blasts in peripheral blood and bone marrow ≤ 10%; 8) Within 7 days before the first dose, absolute absolute neutrophil count (ANC )≥ 1.0×10\\^9\u002FL, platelet count ≥ 50×10\\^9\u002FL, hemoglobin (HGB )\\> 60 g\u002FL (participants should not have received growth factors, colony-stimulating factors, thrombopoietic agents, or platelet transfusions within 2 weeks before the baseline assessment prior to the first dose); 9) Major organ function basically normal within 7 days before the first dose; 10) Able to understand and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n1. Previous anticancer treatment-related toxic reactions have not recovered to grade 1 or below (excluding alopecia and conditions specified in inclusion criteria 8 and 9), or have not fully recovered from previous surgery (major surgery within 4 weeks);\n2. Hypersensitivity, allergic to the investigational drug or its excipients;\n3. Previous intolerance or resistance to ruxolitinib;\n4. Use of JAK inhibitors within 4 weeks before the first dose;\n5. Any significant clinical and laboratory abnormalities that, in the investigator's opinion, affect safety evaluation;\n6. History of congestive heart failure, unstable angina, myocardial infarction, cerebrovascular accident (excluding lacunar infarction), or pulmonary embolism within 6 months prior to screening;\n7. Impaired cardiac function or arrhythmic disease requiring treatment at screening;\n8. Any active infection requiring intravenous antibiotic treatment at screening;\n9. Active tuberculosis infection within 48 weeks prior to screening or latent tuberculosis infection indicated by tuberculosis-related tests during the screening period;\n10. Patients who have undergone splenectomy or received radiation therapy to the spleen area within 12 months before the first dose;\n11. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, except for: a) HBV infection: Patients with positive hepatitis B surface antigen (HbsAg) or hepatitis B core antibody (HbcAb) with undetectable peripheral blood HBV-DNA (below the detection limit of the testing laboratory) can be enrolled; they must continue antiviral therapy and have HBV-DNA testing every 12 weeks and at the end of treatment (EOT); b) HCV seropositive patients with negative HCV RNA can be enrolled.\n12. Positive for human immunodeficiency virus antibody (HIV-Ab) or Treponema pallidum antibody (TP-Ab) (patients with positive Treponema pallidum antibody can have a titer test, and the investigator will determine eligibility based on comprehensive judgment);\n13. Patients with epilepsy or those using psychiatric drugs or sedatives at screening (excluding those used for sleep purposes);\n14. Pregnant or breastfeeding women, and patients with reproductive potential (male and female) who refuse to use contraceptive measures during the trial and for 6 months after the trial;\n15. Patients who have had another malignancy within 5 years before the first dose (excluding cured in-situ carcinoma and basal cell carcinoma of the skin);\n16. Patients with other severe diseases that, in the investigator's opinion, may affect safety or compliance;\n17. Patients who participated in other clinical trials of investigational drugs or medical devices within 1 month before the first dose and used the investigational drug or device;\n18. Use of any treatment for MF (other than JAK inhibitors) within 2 weeks or 5 half-lives (whichever is longer) before the first dose, any immunomodulatory agents (e.g., thalidomide), any immunosuppressants, ≥10 mg\u002Fday prednisone or equivalent biological potency corticosteroids, or growth factors (e.g., erythropoietin (EPO)) (Traditional Chinese medicine should be stopped 1 day before the first dose);\n19. Patients with a history of congenital or acquired bleeding disorders;\n20. Other factors that the investigator deems unsuitable for participation in the trial.","ALL","18 Years",{"count":101,"type":102},75,"ESTIMATED","INTERVENTIONAL",[105],"PHASE2","This trial adopts a multicenter, open-label, positive drug parallel control clinical trial design, planning to enroll approximately 75 MF participants. Eligible participants will be stratified and assigned in a 1:1:1 ratio to the low-dose flonoltinib maleate tablet group, high-dose flonoltinib maleate tablet group, or the ruxolitinib tablet group. Stratification factor include the Dynamic International Prognostic Scoring System (DIPSS) risk classification (intermediate-2 and high risk)",[108],"MF,PMF,PPV-MF,PET-MF","2025-04-07",{"date":111,"type":112},"2025-04-10","ACTUAL",{"date":114,"type":112},"2024-05-06",{"date":116,"type":102},"2026-07-06",{"name":5,"class":6},2]