[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551233":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":26,"studyPopulation":26,"armGroups":33,"interventions":51,"overallOfficials":62,"centralContacts":70,"locations":80,"responsibleParty":114,"collaborators":26,"id":116,"slug":26,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":26,"eligibilityCriteria":121,"healthyVolunteers":117,"sex":122,"minAge":123,"maxAge":26,"enrollmentInfo":124,"targetDuration":26,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":26,"overallStatus":83,"whyStopped":26,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Chengdu Zenitar Biomedical Technology Co., Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":12,"otherOutcomes":26},[9],{"measure":10,"description":10,"timeFrame":11},"Percentage of subjects with ≥35% reduction in spleen volume from baseline(Evaluation by IRC)","Week 24",[13,16,18,21,24],{"measure":14,"description":15,"timeFrame":11},"Percentage of subjects with ≥35% reduction in spleen volume from baseline (Evaluation by researcher)","Percentage of subjects with ≥35% reduction in spleen volume from baseline(Evaluation by researcher)",{"measure":14,"description":14,"timeFrame":17},"Week 12",{"measure":19,"description":20,"timeFrame":17},"Percentage of subjects with ≥35% reduction in spleen volume from baseline (Evaluation by IRC)","Percentage of subjects with ≥35% reduction in spleen volume from baseline( Evaluation by IRC)",{"measure":22,"description":22,"timeFrame":23},"Percentage of subjects with ≥50% reduction in MPN-SAF TSS scale total symptom score","Week 24 and Week 12",{"measure":25,"description":25,"timeFrame":11},"Objective response rate (ORR = CR + PR) per the IWG-MRT consensus criteria.",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":26},"NONE",[34,40,45],{"label":35,"type":36,"description":37,"interventionNames":38},"low dose group","EXPERIMENTAL","Flonoltinib 50mg",[39],"Drug: Flonoltinib 50mg",{"label":41,"type":36,"description":42,"interventionNames":43},"high dose group","Flonoltinib 100mg",[44],"Drug: Flonoltinib 100mg",{"label":46,"type":47,"description":48,"interventionNames":49},"control group","ACTIVE_COMPARATOR","Ruxolitinib",[50],"Drug: Ruxolitinib",[52,56,59],{"type":53,"name":37,"description":54,"armGroupLabels":55,"otherNames":26},"DRUG","Flonoltinib 50mg, QD",[35],{"type":53,"name":42,"description":57,"armGroupLabels":58,"otherNames":26},"Flonoltinib 100mg, QD",[41],{"type":53,"name":48,"description":60,"armGroupLabels":61,"otherNames":26},"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.",[46],[63,67],{"name":64,"affiliation":65,"role":66},"Zhijian Xiao, Doctor","Hematology Hospital, Chinese Academy of Medical Sciences","PRINCIPAL_INVESTIGATOR",{"name":68,"affiliation":69,"role":66},"Ting Niu, Doctor","West China Hospital",[71,76],{"name":72,"role":73,"phone":74,"phoneExt":26,"email":75},"Liangkun Sun","CONTACT","15885742617","liangkunsun@zenitar.cn",{"name":77,"role":73,"phone":78,"phoneExt":26,"email":79},"Zheng Jiang","19048075294","zhengjiang@zenitar.cn",[81,100],{"facility":82,"status":83,"city":84,"state":85,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":95},"West China Hospital Sichuan University","RECRUITING","Chengdu","Sichuan","610000","China","CN",{"type":90,"coordinates":91},"Point",[92,93],104.06667,30.66667,{"lat":93,"lon":92},[96],{"name":97,"role":73,"phone":98,"phoneExt":26,"email":99},"JingZe Zuo","028-85422654","huaxilunli@163.com",{"facility":65,"status":83,"city":101,"state":102,"zip":103,"country":87,"countryCode":88,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Tianjin","Tianjin Municipality","300052",{"type":90,"coordinates":105},[106,107],117.17667,39.14222,{"lat":107,"lon":106},[110],{"name":111,"role":73,"phone":112,"phoneExt":26,"email":113},"Qirou Wang, Doctor","022-23909095","ec@ihcams.ac.cn",{"type":115,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","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":125,"type":126},75,"ESTIMATED","INTERVENTIONAL",[129],"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)",[132],"MF,PMF,PPV-MF,PET-MF","2025-04-07",{"date":135,"type":136},"2025-04-10","ACTUAL",{"date":138,"type":136},"2024-05-06",{"date":140,"type":126},"2026-07-06",{"name":5,"class":6},2]