[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myelofibrosis-post-pv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myelofibrosis-post-pv":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":39,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":4},"100650604","flonoltinib-maleate-oral-regimens-in-patients-with-myelofibrosis-100650604",false,"NCT07750574","Flonoltinib Maleate Oral Regimens in Patients With Myelofibrosis","A Randomized, Phase 2 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Oral Flonoltinib Maleate in Patients With JAK Inhibitor Treatment-Naïve or Resistant Myelofibrosis","FM-MF-02","Inclusion Criteria:\n\nAll participants must:\n\n1. Have signed the current relevant ICF prior to any study related procedures;\n2. Understand and commit to comply with study requirements;\n3. Be ≥18 years of age;\n4. Be able to swallow and retain oral medications;\n5. Be diagnosed with PMF according to the 2016 WHO criteria, or PPV-MF or PET-MF according to International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) criteria;\n6. Have Intermediate-1 to high-risk myelofibrosis (as per Dynamic International Prognostic Scoring System \\[DIPSS\\] risk categories) and be either JAKi-naïve or JAKi-resistant. JAKi-naïve patients include those with JAKi exposure of no more than 14 days. The JAKi-resistant patients need to meet 1 of the following criteria: a) Treatment with JAKi for 3 months with inadequate efficacy response defined as \\\u003C 10% spleen volume reduction (SVR) by Magnetic Resonance Imaging (MRI) or \\\u003C30% decrease from baseline in spleen size by palpation or regrowth to these parameters following an initial response; b) Treatment with JAKi for ≥28 days complicated by any of the following: development of a red blood cell transfusion requirement (at least 2 units\u002Fmonth for 2 months) or cytopenia-related intolerance requiring ≥2 dose reductions or discontinuation of a JAKi; c) Persistent MF-related symptoms defined as less than 50% reduction in TSS (MFSAF V 4.0) after 3 months of JAKi therapy;\n7. Not be intended to undergo stem cell transplantation for at least 6 months;\n8. Have life expectancy per investigator assessment ≥ 12 weeks;\n9. Have Eastern Cooperative Oncology Group (ECOG) score ≤ 2;\n10. Have splenomegaly: palpable spleen extending at least 5 cm below the costal margin or unpalpable due to body habitus (obesity), but confirmed to be ≥450 cm³ by MRI (or computed tomography \\[CT\\] scan) at screening;\n11. Have at least 2 symptoms with an average score ≥3 over the 7-day period prior to randomization or an average total score of ≥10 over the 7-day period prior to randomization using the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0;\n12. Have bone marrow blast cells ≤10% and peripheral blood blast cells ≤10%;\n13. Have PLT ≥50 × 109 \u002FL and absolute neutrophil count (ANC) ≥ 1.0 × 109 \u002FL and hemoglobin (HGB) \\>60 g\u002FL without the assistance of CSF, EPO, TPO, or component blood transfusions. Have discontinued growth factors and platelets transfusions for more than 2 weeks before screening tests;\n14. Have no overt significant disease involving heart, lungs, liver, kidneys, or pancreas (left ventricular ejection fraction ≥ 45%; serum direct bilirubin ≤2 × upper limit of normal \\[ULN\\]; serum creatinine ≤1.5 × ULN or Estimated Glomerular Filtration Rate \\[eGFR\\] by the 2021 chronic kidney disease-Epidemiology Collaboration formula ≥ 45 mL\u002Fmin\u002F1.73 m2; alanine aminotransferase \\[ALT\\] and aspartate aminotransferase \\[AST\\] ≤2.5 × ULN) or ≤5 × ULN if associated with liver MF involvement;\n15. Have no severe coagulation dysfunction (prothrombin time \\[PT\\] or thrombin time \\[TT\\] ≤2 × ULN; activated partial thromboplastin time \\[APTT\\] ≤2 × ULN);\n16. Have a normal thiamine level at the time of study entry;\n17. Agree to comply with the relevant regulations of the treating institution and the research organization.\n\nExclusion Criteria:\n\nParticipants must not:\n\n1. Have failure to recover from toxic effects of prior anticancer therapy to Grade 1 or below (except alopecia), or failure to fully recover from prior surgery (major surgery within 4 weeks);\n2. Have known hypersensitivity to the investigational product or its excipients;\n3. Have any significant clinical or laboratory abnormality that would interfere with accurate safety evaluation on study, including:\n\n   1. Uncontrolled diabetes with fasting blood glucose \\>250 mg\u002FdL (13.9 mmol\u002FL);\n   2. Hypertension not controlled by one or two antihypertensive drugs to the following range: systolic \\\u003C160 mmHg, diastolic \\\u003C100 mmHg;\n   3. Peripheral neuropathy of Grade 2 or higher according to Common Terminology Criteria for Adverse Events (CTCAE) v6.0;\n   4. Thyroid dysfunction of Grade 2 or higher per CTCAE v6.0;\n   5. Any other relevant abnormality in the opinion of the investigator;\n4. Have a history of congestive heart failure, unstable angina, myocardial infarction, cerebrovascular accident, or pulmonary embolism within the 6 months prior to screening;\n5. Have impaired cardiac function including any of the following conditions as determined by echocardiogram or electrocardiogram (ECG): left ventricular ejection fraction less than 45%, or complete left bundle branch block with ST-segment depression greater than 1 mm or T-wave inversion across 2 or more leads. Other criteria include congenital ventricular arrhythmias, clinically significant tachycardia (greater than 100 beats per minute), bradycardia (less than 50 beats per minute) with accompanying clinical symptoms, heart rate less than 60 beats per minute with symptoms, an ECG Corrected QT Interval (QTc) interval greater than 450 ms, or clinically significant cardiac conditions such as unstable angina, congestive heart failure, or myocardial infarction occurring within the last 6 months. Patients with heart failure who meet New York Heart Association class III and IV definitions are ineligible for this study;\n6. Have an active serious infection requiring treatment at the time of screening;\n7. Have undergone splenectomy or who have received splenic irradiation within 6 months prior to screening;\n8. Have Human Immunodeficiency Virus (HIV) positive, active Hepatitis B (Hepatitis B Surface Antigen \\[HBsAg\\] positive and Hepatitis B Virus \\[HBV\\]-DNA ≥1000 copies\u002FmL), or positive for Hepatitis C Virus (HCV) antibodies or HCV-RNA at screening;\n9. Have epilepsy or are taking psychotropic or sedative medications at screening;\n10. Be women of childbearing potential (WOCBP): who are unwilling or unable to practice highly effective contraception before the initial dose\u002Fstart of the first treatment, during the study, and for at least 6 months after the last dose. Highly effective contraceptive measures include:\n\n    i) Stable use of combined (estrogen and progestogen-containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles before screening; ii) Intrauterine device; intrauterine hormone-releasing system; iii) Sexual abstinence; iv) Intercourse with a vasectomized partner (the male vasectomized partner is the sole sexual partner of the WOCBP study patient, the vasectomized partner has obtained medical assessment of surgical success for the procedure);\n11. Be sexually active male patients with WOCBP partners who are unwilling to use 1 of the following forms of medically acceptable birth control at the start of the first treatment, during the study, and for at least 6 months after the last dose:\n\n    i) Vasectomy with medical assessment of surgical success or consistent use of a condom; ii) Male Participants must also agree not to donate sperm while receiving the investigational product and for at least 6 months after the last dose;\n12. Have a history of malignancy within the 3 years prior to study screening (except for successfully treated basal cell carcinoma of the skin or carcinoma in situ of the cervix);\n13. Have any other severe illnesses that the investigator feels may jeopardize Participant safety or compliance;\n14. Have participated in an investigational agent or medical device study within 1 month prior to screening;\n15. Have prior or concomitant treatment with any of the following: any myelofibrosis therapy (except hydroxyurea that may be stopped one day before first dose; prior JAKi is allowed with a ≥14 day washout); any immunomodulators (e.g., thalidomide); any immunosuppressants; androgenic steroids systemic corticosteroids ≥10 mg\u002Fday prednisone equivalent; or any growth factor (e.g., EPO) within 5 half lives or 2 weeks before enrollment (whichever is longer);\n16. Have received potent or moderate cytochrome P450 (CYP)3A4 inhibitors (including but not limited to ketoconazole, clarithromycin, itraconazole, nefazodone, telithromycin) or potent CYP3A4 inducers (including but not limited to rifampin and St. John's wort) within 2 weeks before the first dose;\n17. Have received concomitant QT-prolonging medications that cannot be discontinued or appropriately managed in accordance with the QTc Monitoring Plan;\n18. Have received concomitant strong inhibitors\u002Finducers of P-gp or Breast Cancer Resistance Protein (BCRP)；\n19. Have congenital or acquired bleeding disorders;\n20. Be alcohol dependent or drug abusers;\n21. Consume grapefruit, starfruit, or their products within 48 hours of the first dose of study medication, or be unwilling to abstain from such products while on study as these substances may affect drug absorption, distribution, metabolism, or excretion;\n22. Have any other severe and\u002For uncontrolled concomitant medical condition that in the opinion of the investigator could compromise participation in the study or analysis of study data.\n\n    \\-","ALL","18 Years",{"count":20,"type":21},105,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is to learn which of three different doses of Flonoltinib Maleate taken by mouth daily works best to treat adult patients with myelofibrosis in whom the most common approved therapy has failed to adequately control the disease. It will also learn about the safety of the three different daily doses of Flonoltinib Maleate. The main questions it aims to answer are:\n\nWhich dose is the best at controlling the symptoms and signs of organ damage caused by myelofibrosis? What medical problems do participants have when taking the three different doses of Flonoltinib Maleate? Researchers will compare the three different doses of Flonoltinib Maleate to see which dose is best to treat patients with myelofibrosis.\n\nParticipants will:\n\nTake Flonoltinib Maleate every day for as long as it seems to be of benefit to them in terms of controlling myelofibrosis.\n\nVisit the clinic for checkups and tests after giving fully informed written consent confirming that they would like to consider entering the study.\n\nVisit the clinic for checkups and tests when on the study once every 2 weeks for the first 2 months, every 4 weeks after that, and when coming off study therapy.\n\nKeep a diary of their symptoms.",[27,28,29,30,31,32,33,34,35,36,37,38],"Myelofibrosis","Myelofibrosis Due to and Following Polycythemia Vera","Myelofibrosis Transformation in Essential Thrombocythemia","Myelofibrosis With High Molecular Risk Mutations","Myelofibrosis With Myeloid Metaplasia","Myelofibrosis, Post ET","Myelofibrosis, Post PV","Myelofibrosis, Primary","Myelofibrosis; Anemia","Myelofibrosis，MF","Myelofibrosis (PMF)","Myeloid Metaplasia",[40],"Myelofibrosis. JAK inhibitor therapy. De-novo diagnosis. Prior JAK inhibitor therapy. Novel JAK inhibitor. JAK2. FLT3. CDK6.","NOT_YET_RECRUITING","2026-08-05",{"date":44,"type":45},"2026-08-10","ACTUAL",{"date":47,"type":21},"2026-11",{"date":49,"type":21},"2028-11",{"name":51,"class":52},"Chengdu Zenitar Biomedical Technology Co., Ltd","INDUSTRY",{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":111,"overallStatus":143,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":5},"100620792","mpn-progression-registry-observational-study-tracking-symptoms-treatments-and-disease-progression-in-people-with-myeloproliferative-neoplasms-mpns-100620792","NCT07362225","MPN PROGRESSion Registry: Observational Study Tracking Symptoms, Treatments, and Disease Progression in People With Myeloproliferative Neoplasms (MPNs)","The MPN PROGRESSion Registry: A Retrospective and Prospective Observational Study Collecting Patient-Reported Outcomes, Electronic Health Records, and Claims Data to Track Symptoms, Treatments, and Disease Progression in Individuals Diagnosed With Myeloproliferative Neoplasms (MPNs).","Inclusion Criteria:\n\n* Adults aged 18 years or older at the time of enrollment.\n* Confirmed diagnosis of a myeloproliferative neoplasm (MPN), including one or more of the following subtypes, according to WHO 2022 criteria, including patients originally diagnosed with one of these conditions but who have received one or more stem cell transplants (SCTs) or bone marrow transplants (BMTs):\n* Polycythemia vera (PV)\n* Essential thrombocythemia (ET)\n* Primary myelofibrosis (PMF)\n* Secondary myelofibrosis (post-ET or post-PV MF)\n* Pre-fibrotic primary myelofibrosis (pre-PMF)\n* Myeloproliferative neoplasm-unclassifiable (MPN-U)\n* Myeloproliferative neoplasm, accelerated phase (MPN-AP)\n* Myeloproliferative neoplasm, blast phase (MPN-BP)\n* Post-MPN acute myeloid leukemia (AML)\n* Myelodysplastic syndrome (MDS)\u002FMPN overlap syndrome\n* Myeloproliferative neoplasm, blast phase (MPN-BP)\n* Ability to provide informed consent electronically or through a legally authorized representative.\n* Willingness to share health information, including electronic health records (EHR), laboratory values, and survey responses.\n* Willingness to complete periodic patient-reported outcome (PRO) surveys and symptom tracking assessments.\n\nExclusion Criteria:\n\n* Individuals under 18 years of age.\n* Inability to provide informed consent, either directly or through a legally authorized representative.\n* Currently enrolled in an interventional clinical trial where participation would interfere with the ability to participate in this observational registry (based on investigator or sponsor judgment).\n* Any condition that, in the judgment of the study team, would make participation in the registry infeasible or unsafe.",{"count":61,"type":21},5000,"OBSERVATIONAL","The MPN PROGRESSion Registry is a multi-year, observational research study designed to improve understanding of myeloproliferative neoplasms (MPNs)-a group of rare, chronic blood cancers that include polycythemia vera (PV), essential thrombocythemia (ET), primary myelofibrosis (MF), pre-fibrotic primary myelofibrosis (pre-PMF), secondary myelofibrosis, myeloproliferative neoplasm-unclassifiable (MPN-U), MPN in accelerated phase (MPN-AP), and MPN in blast phase (MPN-BP), post-MPN Acute Myeloid Leukemia (AML), and MDS\u002FMPN overlap syndrome as defined above per WHO 2022 criteria, including patients originally diagnosed with one of these conditions but who have received one or more SCTs and\u002For BMTs . These conditions are characterized by abnormal blood cell production in the bone marrow and may lead to complications such as blood clots, bleeding, bone marrow fibrosis, and, in some cases, progression to acute leukemia.\n\nThe central hypothesis of the registry is that collecting and analyzing real-world, longitudinal data-including electronic health records (EHRs), laboratory values, treatments, and patient-reported outcomes (PROs)-from a diverse population of people living with MPNs will help identify patterns and predictors of disease progression, treatment response, quality of life, and long-term outcomes. These insights are intended to guide future research, inform clinical guidelines, and support improvements in patient care.\n\nThe registry is non-interventional and observational; participants do not receive investigational treatments, and all medical care continues under the supervision of their own physicians. Data collection includes EHRs, PRO surveys, patient-reported symptom and lab tracking, insurance claims, and, in the future, may include linkages with other relevant disease registries and datasets. Potential collaborations under consideration include those with the European LeukemiaNet (ELN) MPN Registry, the Mayo Clinic MPN Database, the Center for International Blood and Marrow Transplant Research (CIBMTR), the SEER Program, Harmony Alliance Foundation, and the National Cancer Database (NCDB).\n\nThe registry emphasizes the patient voice, incorporating lived experiences related to hallmark MPN symptoms such as fatigue, pruritus (itching), bone pain, night sweats, and social and emotional impacts. Participants will be followed for at least five years, with many enrolled for ten years or longer, to capture the natural history of disease and long-term outcomes. PRO surveys will be completed approximately every six months, and EHR data will be regularly reviewed to track changes in clinical status, treatment, and disease evolution.\n\nStatistical analyses will use descriptive and inferential methods to examine clinical characteristics, symptom burden, disease trajectories, and patient-centered outcomes. Planned subgroup analyses may compare differences across diagnoses, treatment approaches, demographics, or genomic factors. Analytic plans will be finalized during the course of the study and may evolve in response to emerging scientific questions.\n\nThe registry is open to adults (18 years or older) living in the United States who have been diagnosed with any of the included MPN subtypes and are willing to share health information and complete study surveys. Individuals currently enrolled in interventional clinical trials or unable to provide informed consent may be excluded. Participation is voluntary, and participants may withdraw from the study at any time without affecting their medical care.\n\nPrivacy and data security are core priorities. Participant data will be securely stored and managed in accordance with all applicable privacy laws and research regulations. No identifiable information will be shared with external parties without appropriate authorization. Oversight is provided by a Steering Committee and a Patient Engagement Advisory Committee (PEAC), ensuring rigorous scientific, ethical, and patient-centered governance.\n\nThe registry is sponsored by the MPN Research Foundation, a nonprofit organization advancing research and patient advocacy in myeloproliferative neoplasms (MPNs). Participants can contact the registry team at any time with questions and will receive periodic updates on study findings.\n\nThis study aims to address critical gaps in understanding the real-world experiences of people with MPNs-such as symptom burden over time, risk factors for progression, and how different treatments impact patient outcomes. Findings may inform clinical trial design, support biomarker discovery, and contribute to the development of updated treatment recommendations. The registry is committed to including participants from diverse backgrounds and clinical settings to ensure findings are broadly applicable across the MPN community. Summary results will be shared through scientific publications, presentations, and other dissemination efforts to advance MPN research and care globally.",[65,66,67,68,69,70,27,71,34,32,33,37,36,72,28,29,30,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110],"Polycythemia Vera","ET (Essential Thrombocythemia)","Polycythemia Vera (PV)","Essential Thrombocythemia (ET)","Primary Myelofibrosis (MF)","Primary Myelofibrosis (PMF)","Myelofibrosis (MF)","Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis","MF","Secondary Myelofibrosis","Secondary Myelofibrosis in Myeloproliferative Disease","Secondary Myelofibrosis (Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis)","Post-Polycythemia Vera Myelofibrosis","Post-polycythemia Vera Myelofibrosis (PPV-MF)","Post-polycythemia Vera Myelofibrosis (Post-PV MF)","Post-polycythemia Vera Myelofibrosis(Post-PV MF)","Post-PV MF","Post-Essential Thrombocythemia Myelofibrosis","Post-essential Thrombocythemia Myelofibrosis (PET-MF)","Post-essential Thrombocythemia Myelofibrosis(Post-ET MF)","Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)","Post-ET MF","Pre-fibrotic Myelofibrosis","Myeloproliferative Disorder","Myeloproliferative Disorders","Myeloproliferative Disorders (MPD)","Myeloproliferative Neoplasms (MPNs)","Myeloproliferative Neoplasm(MPN)-Associated Myelofibrosis","Myeloproliferative Neoplasm With 10% Blasts or Higher","Myeloproliferative Neoplasms","MPN","MPN (Myeloproliferative Neoplasms)","MPN-associated Myelofibrosis","Myeloproliferative Neoplasm, Unclassifiable","Myeloproliferative Neoplasm, Not Otherwise Specified","Accelerated Phase MPN","Accelerated Phase Myeloproliferative Neoplasm","Blast Phase MPN","Blast Phase Myeloproliferative Neoplasm","Thrombocythemia Myelofibrosis (PET-MF)","Thrombocythemia, Essential","Thrombocythemia, Hemorrhagic","Agnogenic Myeloid Metaplasia","Chronic Idiopathic Myelofibrosis","Idiopathic Myelofibrosis","MDS\u002FMPN Crossover Syndromes",[94,65,112,74,113,88,98,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142],"Essential Thrombocythemia","Pre-fibrotic Primary Myelofibrosis","Myeloproliferative Neoplasm, Accelerated Phase","Myeloproliferative Neoplasm, Blast Phase","Chronic Myeloproliferative Disease","Hematologic Neoplasms","Bone Marrow Neoplasms","Blood Cancer","Disease Progression","Biomarker Discovery","Patient-Reported Outcomes","Electronic Health Records","Real-World Evidence","Longitudinal Study","Observational Study","Registry Study","Natural History Study","Quality of Life","Rare Diseases","Chronic Hematologic Diseases","Risk Stratification","Symptom Burden","Medical Claims Data","Longitudinal Data Collection","Patient-Centered Research","Health Outcomes Research","Clinical Outcomes","Clinical Guidelines Development","Regulatory Science","Drug Development","Treatment Response","RECRUITING","2026-01-15",{"date":146,"type":45},"2026-01-23",{"date":148,"type":45},"2025-09-26",{"date":150,"type":21},"2035-09-08",{"name":152,"class":153},"MPN Research Foundation","OTHER"]