[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"polycythemia-vera-pv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:polycythemia-vera-pv":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,45,83,106,130,150,253,279,299,327,360],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100627227","a-clinical-study-of-gecacitinib-combined-with-pegylated-interferon-in-patients-with-pv-100627227",false,"NCT07445893","A Clinical Study of Gecacitinib Combined With Pegylated Interferon in Patients With PV","A Clinical Study of Gecacitinib Hydrochloride Tablets Combined With Pegylated Interferon as First-line Treatment in Patients With Polycythemia Vera (PV)","Inclusion Criteria:\n\n* Aged ≥18 years\n* Diagnosis of polycythemia vera (PV) according to the 2022 International Consensus Classification (ICC) criteria;\n* Presence of at least one of the following disease manifestations, defined as:\n\n  a. Peripheral hematological abnormality: HCT ≥45% and\u002For PLT \\>400×10⁹\u002FL and\u002For WBC ≥10×10⁹\u002FL in the absence of phlebotomy; b. Presence of weight loss \\>10% over the past 6 months, night sweats, pruritus, or unexplained fever (\\>37.5°C); c. Progressive splenomegaly (previous splenomegaly with an increase \\>5 cm from baseline or newly developed splenomegaly); d. History of prior thrombotic or hemorrhagic events;\n* No current plan for stem cell transplantation;\n* Life expectancy \\>24 weeks;\n* ECOG performance status 0-2;\n* Able to swallow tablets;\n* Patients without prior pegylated interferon or JAK inhibitor treatment; patients previously treated with hydroxyurea or therapeutic phlebotomy are eligible; patients who discontinued interferon for ≥6 months due to causes other than resistance or intolerance can be enrolled；\n* No receipt of growth factors, colony-stimulating factors, thrombopoietin, or platelet transfusion within 2 weeks prior to screening, with platelet count ≥100×10⁹\u002FL and ANC ≥1.5×10⁹\u002FL;\n* Adequate major organ function, defined asALT and AST ≤2.5 × ULN;DBIL and TBIL ≤2.0 × ULN;Serum creatinine ≤1.5 × ULN;\n* Peripheral blood blasts 0%;\n* Voluntary signed informed consent in accordance with ethics committee requirements;\n* Able to comply with study and follow-up procedures.\n\nExclusion Criteria:\n\n* Any significant clinical or laboratory abnormality considered by the investigator to affect safety assessment, such as:a. Uncontrolled diabetes (\\>250 mg\u002FdL or \\>13.9 mmol\u002FL);b. Hypertension that cannot be reduced to the following range despite combination antihypertensive therapy (systolic blood pressure \\\u003C160 mmHg, diastolic blood pressure \\\u003C100 mmHg);c. Peripheral neuropathy (Grade ≥2 according to NCI-CTCAE V5.0).\n* History of congestive heart failure (Grade ≥3 according to NCI-CTCAE V5.0), uncontrolled or unstable angina pectoris or myocardial infarction, cerebrovascular accident, or pulmonary embolism within 24 weeks prior to screening.\n* Patients who have undergone major surgery within 4 weeks prior to screening and have not fully recovered.\n* Patients who have received PEG-IFN-α-2a or have a history of ³²P therapy within 5 weeks prior to screening.\n* Patients diagnosed with primary immunodeficiency syndrome (e.g., X-linked agammaglobulinemia and common variable immunodeficiency).\n* Patients with arrhythmic disorders requiring treatment at screening (except digoxin).\n* Patients with any clinically symptomatic bacterial, viral, parasitic, or fungal infection requiring treatment at screening.\n* Patients with active pulmonary infection indicated by chest CT examination at screening.\n* Patients previously diagnosed with active tuberculosis infection, or subjects judged as suspected active tuberculosis infection by investigator at screening.\n* Patients who have undergone splenectomy or have received splenic radiation therapy within 48 weeks prior to screening.\n* Patients who are HIV positive, have active hepatitis B virus infection (HBsAg positive and HBV-DNA positive or above the normal reference range), or are anti-HCV antibody positive with HCV-RNA positive at screening.\n* Patients with epilepsy or those using psychiatric or sedative medications at screening (except for Estazolam tablets).\n* Female patients who are planning to become pregnant, are pregnant, or are breastfeeding, and patients who are unable to use effective contraception throughout the study period; male patients who do not use condoms during the administration period and for 2 days (approximately 5 half-lives) after the last dose.\n* Patients with a history of malignancy within the past 5 years (except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).\n* Presence of other severe diseases that, in the investigator's opinion, may affect patient safety or compliance.\n* Patients with suspected allergy to Gecacitinib Hydrochloride, interferon, or similar drugs.\n* Patients with active alcohol or drug addiction that would interfere with their ability to comply with study requirements.\n* Patients who have participated in another investigational new drug or medical device study and have received study drug or used study device within 12 weeks prior to screening.\n* Patients who have used any immunomodulators, any immunosuppressants, ≥10 mg\u002Fday prednisone or equivalent corticosteroids, or are within 6 half-lives of such medications within 2 weeks prior to enrollment, whichever is longer.","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this clinical trial is to evaluate the efficacy and safety of Gecacitinib in combination with pegylated interferon for the treatment of polycythemia vera (PV).The main question it aims to answer is:\n\nCan PV patients achieve hematological remission after receiving the combination therapy?\n\nParticipants will:\n\nReceive combination treatment with Gecacitinib Hydrochloride Tablets and pegylated interferon for 24 weeks Visit the hospital regularly for examinations and follow-up assessments",[26],"Polycythemia Vera (PV)",[28,29,30,31],"PV","Gecacitinib","Pegylated Interferon","JAKi","RECRUITING","2026-06-21",{"date":35,"type":36},"2026-06-24","ACTUAL",{"date":38,"type":36},"2026-04-02",{"date":40,"type":20},"2028-12-30",{"name":42,"class":43},"Duan Minghui","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":63,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100629072","phase-1-a-phase-1-study-of-prt12396-in-participants-with-select-myeloproliferative-neoplasms-100629072","NCT07469891","A Phase 1 Study of PRT12396 in Participants With Select Myeloproliferative Neoplasms","A Phase 1, Open-Label, Multi-Center, Safety and Efficacy Study of PRT12396 in Participants With Polycythemia Vera and Myelofibrosis","Inclusion Criteria:\n\n* Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations (including contraception requirements), and other study procedures.\n* Confirmed diagnosis of PV or MF according to WHO 2016 or revised ICC\u002FWHO 2022 criteria\n* Documented presence of a JAK2 V617 mutation\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Estimate life expectancy of ≥12 weeks per investigator assessment.\n* Negative serum or urine pregnancy test and agree to use contraception or maintain true abstinence.\n* Adequate organ function and bone marrow reserves (hematology, renal, and hepatic)\n\nExclusion Criteria:\n\n* History of another malignancy within 3 years prior to enrollment, except for malignancy considered cured with low risk of recurrence.\n* Clinically significant anemia due to nutritional deficiency or hemolytic disorders.\n* Active or uncontrolled infection requiring systemic therapy or hospitalization.\n* Any other medical or psychiatric conditions that, in the Investigator's judgment, would increase risk or interfere with study participation or interpretation of results.\n* Clinically significant or uncontrolled medical conditions, including active infection or cardiovascular disease, that would increase risk or interfere with study participation.\n* Unresolved toxicity \\> Grade 1 from prior anticancer therapy, except for alopecia or peripheral neuropathy ≤ Grade 2.\n* Pregnancy or breastfeeding\n* Known sensitivity or contraindication to any component of study, or the excipients of study treatment.\n* Prior systemic therapy for PV or MF, prior or planned allogeneic hematopoietic stem-cell transplantation, recent major surgery, prior splenectomy or prior splenic irradiation, or use of hematopoietic growth factors within protocol-defined washout periods.\n* Use of strong or moderate cytochrome P450 (CYP) 3A4 inhibitor or inducer, sensitive CYP3A substrates with narrow therapeutic range, or acid-reducing agents that cannot be discontinued prior to study treatment.\n* Participation in another interventional clinical study.",{"count":53,"type":20},100,[55],"PHASE1","This is a first-in-human, open-label, multi-center Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of PRT12396 in participants with high-risk polycythemia vera (PV) and myelofibrosis (MF), and to determine the maximum tolerated dose (MTD) and recommended dose(s) for expansion (RDE\\[s\\]). The study consists of a dose-escalation phase followed by a dose-expansion phase to further evaluate selected dose level(s).",[26,58,59,60,61,62],"Myelofibrosis (MF)","Myeloproliferative Neoplasms (MPNs)","Post-Polycythemia Vera Myelofibrosis","Post-Essential Thrombocythemia Myelofibrosis","Primary Myelofibrosis (PMF)",[64,65,66,67,68,69,70,71],"High-Risk Polycythemia Vera (PV)","Intermediate-1 or Intermediate-2 Risk Primary MF","High-Risk Primary MF","Post-Polycythemia Vera MF","Post-Essential Thrombocythemia MF","PRT12396","JAK Inhibitor","Myeloproliferative Neoplasms (MPN)","2026-06-05",{"date":74,"type":36},"2026-06-09",{"date":76,"type":36},"2026-04-29",{"date":78,"type":20},"2028-04",{"name":80,"class":81},"Prelude Therapeutics","INDUSTRY",5,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":21,"phases":92,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100591801","phase-2-a-phase-2-open-label-study-of-disc-3405-in-participants-with-polycythemia-vera-pv-100591801","NCT06985147","A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV)","A Phase 2, Open-Label Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DISC-3405 in Participants With Polycythemia Vera (PV)","Inclusion Criteria:\n\n1. Aged 18 years or older at the time of signing the informed consent form (ICF).\n2. Meet revised 2022 World Health Organization (WHO) criteria for the diagnosis of PV.\n3. Complete blood count values at Screening of HCT \\\u003C45% or HCT \\\u003C48% if followed by a phlebotomy within 2 weeks, white blood cells 4000\u002FμL to 20,000\u002FμL (inclusive), and platelets 100,000\u002FμL to 1,000,000\u002FμL (inclusive).\n4. At least 3 phlebotomies in 26 weeks before Screening or at least 5 phlebotomies in 52 weeks before Screening. At least 1 phlebotomy must be within the 12 weeks prior to Screening.\n5. Participants receiving cytoreductive therapy must have been taking for at least 6 months and be on a stable PV therapy regimen for at least 2 months for hydroxyurea, interferon or ruxolitinib with no anticipated need for dose adjustments during the study, or have decreasing dose (with medical monitor approval).\n6. Participants treated with phlebotomy alone must have stopped cytoreductive therapy 6 months before Screening.\n7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, or with medical monitor approval, ECOG 2.\n8. If male with female sexual partner(s) of childbearing potential, agrees to use one of the following acceptable methods of contraception during the study and for at least 120 days after the last study drug dose:\n\n   1. Stable hormonal contraceptive (≥3 months; female partner) in conjunction with a barrier method (eg, condom or diaphragm \\[female partner\\])\n   2. Intrauterine device in place for at least 3 months (female partner)\n   3. Surgically sterile hysterectomy, bilateral oophorectomy, or bilateral tubal ligation (female partner) in conjunction with a barrier method (eg, condom \\[male or female\\] or diaphragm)\n   4. Confirmed successful vasectomy in conjunction with a barrier method (eg, condom \\[male or female\\] or diaphragm)\n9. If female, then EITHER postmenopausal, defined as at least 12 months of natural, spontaneous amenorrhea, 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone \\>40 mIU\u002FmL at Screening, or at least 6 weeks following surgical menopause (bilateral oophorectomy with or without hysterectomy); surgically sterile, OR agreeable to use of highly effective contraception (listed below) on Day 1 (or earlier) and for at least 120 days after the last dose of study drug:\n\n   1. Stable hormonal contraceptive (≥3 months) in conjunction with a barrier method (eg, condom \\[male or female\\] or diaphragm)\n   2. Intrauterine device in place for at least 3 months\n   3. Tubal ligation or single male partner with vasectomy in conjunction with a barrier method (eg, condom \\[male or female\\] or diaphragm)\n10. Negative pregnancy test (females of childbearing potential).\n11. Able to understand the study aims, procedures, and requirements, and provide written informed consent.\n12. Able to comply with all study procedures.\n\nExclusion Criteria:\n\n1. Clinically significant laboratory abnormalities at Screening.\n2. Participants who require phlebotomy at HCT levels \\\u003C45%.\n3. Clinically significant thrombosis (eg, deep vein thrombosis or splenic vein thrombosis) within 2 months prior to study treatment.\n4. Clinically significant active or chronic bleeding, considered meaningful in consultation with the medical monitor, within 6 months prior to study treatment.\n5. Significant renal dysfunction, evidenced by estimated glomerular filtration rate of \\\u003C30 mL\u002Fmin\u002F1.73 m2 at the Screening visit, as assessed locally.\n6. History of invasive malignancies within the last 5 years, except localized cured prostate cancer and cervical cancer, or other malignancies deemed acceptable by the Sponsor.\n7. Participants with in situ or stage 1 squamous cell carcinoma of the skin, in situ or stage 1 basal cell carcinoma of the skin, or in situ melanoma of the skin identified during Screening unless the cancer is adequately treated before study entry.\n8. Received busulfan, pipobroman, or phosphorus-32 within 7 months prior to Screening.\n9. Major surgery within 8 weeks before Screening or incomplete recovery from any previous surgery.\n10. A history or known allergic reaction to any investigational product excipients or history of anaphylaxis to any food or drug.\n11. History of alcohol dependence or excessive alcohol consumption, as assessed by the Investigator.\n12. Active human immunodeficiency virus (HIV), hepatitis B or C. A positive hepatitis or HIV result should be discussed between the Investigator and Sponsor prior to enrollment.\n13. Other medical or psychiatric condition or laboratory finding not specifically noted above that, in the judgment of the Investigator or Sponsor, would put the participant at unacceptable risk or otherwise preclude the participant from participating in the study.\n14. Condition or concomitant medication that would confound the ability to interpret clinical data, including a major psychiatric condition that has had an exacerbation or required hospitalization in the last 6 months.\n15. If female, pregnant or breastfeeding.\n16. Participation in any other clinical protocol or investigational study that involves administration of experimental therapy and\u002For therapeutic devices within 30 days (or 5 half-lives for drugs, whichever is longer) of Screening. Previous use of other hepcidin inducing agents that may impact TMPRSS6 expression are not allowed. Previous use of hepcidin mimetics may be allowed in discussion with the Sponsor.",{"count":91,"type":20},60,[93],"PHASE2","This open-label, multicenter, within-participant dose escalation study examining up to 2 dose levels of DISC-3405 will assess the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of DISC-3405 in participants with polycythemia vera (PV).",[26],"2026-05-26",{"date":98,"type":36},"2026-05-28",{"date":100,"type":36},"2025-08-12",{"date":102,"type":20},"2029-02",{"name":104,"class":81},"Disc Medicine, Inc",15,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":115,"conditions":116,"keywords":117,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":128,"locationsCount":4},"100633689","phase-1-study-of-ze74-0282-for-patients-with-jak2-v617f-positive-blood-cancers-100633689","NCT07529951","Study of ZE74-0282 for Patients With JAK2 V617F Positive Blood Cancers","A Dose Finding Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of ZE74-0282 in Select JAK2 V617F Mutated Hematologic Disorders","Inclusion Criteria:\n\n1. Patient is ≥18 years of age at the time of obtaining informed consent.\n2. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n3. Patient has histological confirmation JAK2 V617F mutated hematologic diagnosis with later confirmation using ipsogen® JAK2 RGQ PCR Kit) with prior therapy or who have declined them.\n4. All AEs related to prior therapies (chemotherapy\u002Fsystemic therapies, radiation, surgery) must have resolved to Grade 1 or baseline except for:\n\n   1. Alopecia (Grade ≤2)\n   2. Sensory neuropathy (Grade ≤2)\n   3. Other AEs that have resolved to Grade ≤2 that, according to the clinical judgment of the investigator, do not constitute a safety risk to the patient.\n5. Adequate hematologic function including\n6. Organ function\u002Freserve as per the following laboratory criteria:\n\n   1. Hepatic: Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 2.5 x ULN, and total bilirubin \\\u003C 2 x ULN (except for patients with known or suspected Gilbert's syndrome and with direct bilirubin within normal range) for the local laboratory. If due to disease, higher values may be approved after discussion with medical monitor.\n   2. Renal: Adequate renal function as defined by calculated creatinine clearance \\>45 mL\u002Fmin for the local laboratory.\n7. Baseline corrected QT interval by Fredericia (QTcF) \\\u003C 470 ms. Patients with right, left, or partial bundle branch blocks or pacemaker that may confound interpretation of this reading are not excluded from this provided they lack history of primary arrhythmic events and are cleared by cardiology for enrollment in the trial.\n8. Pregnancy:\n\n   1. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test result at screening (not applicable to patients who are unable to become pregnant, including those with bilateral oophorectomy and\u002For hysterectomy). The test must be performed within 72 hours before Day 1 of treatment.\n   2. Women of non-child-bearing potential must have at least 12 continuous months of natural (spontaneous) amenorrhea and an appropriate clinical profile (e.g., age appropriate or history of vasomotor symptoms) or have had surgical sterilization (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) \\>42 days prior to screening.\n9. Contraception and Gamete Donation:\n\n   1. Male patients with a WOCBP partner must use 2 forms of acceptable contraception, including 1 barrier method, during their participation in the study and for 120 days following the last dose of the study treatment. They must also refrain from sperm donation from screening visit until 120 days following the last dose of study treatment.\n   2. Women of child-bearing potential must use 2 forms of acceptable contraception, including 1 barrier method, during their participation in the study and for 120 days following the last dose of the study treatment. They must also refrain from ova donation from screening visit until 120 days following the last dose of study treatment.\n10. Written informed consent must be obtained according to local guidelines and signed and dated by the patient prior to the performance of any study specific procedures, sampling, or analyses.\n\nExclusion Criteria:\n\n1. Clinical signs\u002Fsymptoms of leukostasis or thrombophilia require urgent therapy (phereses).\n2. Known active infection with Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C. Patients with a history of positive serology for hepatitis B or C require a negative Polymerase chain reaction (PCR) test for virus to go onto therapy.\n3. Disseminated intravascular coagulopathy with active, unmanageable bleeding or signs of thrombosis.\n4. Patients who have received an investigational agent (for any indication) \\\u003C14 days prior the first dose of ZE74-0282; an investigational agent is one for which there is no approved indication by the United States (US) FDA or by the applicable regulatory authority in the country where the study is being conducted. Additionally, the first dose of ZE74-0282 should not occur before the shorter of 28 days or a period of 5 half-lives of the investigational drug; if the half-life of the agent is unknown, patients must wait 4 weeks prior to first dose of study treatment.\n5. Systemic antineoplastic or radiotherapy \\\u003C14 days prior to the first day of ZE74-0282 administration (Hydroxyurea is allowed prior to study to control counts and may be given during study until completion of cycle 2.\n6. Female patients who are pregnant, lactating, or planning to become pregnant or initiate breastfeeding.\n7. Patients with psychological, familial, social, or geographic factors, other significant medical condition, laboratory abnormality that otherwise preclude them from giving informed consent, following the protocol, potentially hamper compliance with study treatment and follow-up or would confound the interpretation of the results of the study.\n8. Patients with the following will be excluded: uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, myocardial infarction with evidence of residual abnormalities, stroke or transient ischemic attack within 6 months prior to enrollment (Troponin (regular or high sensitivity) leak alone not included if no residual dysfunction),\n9. Patients with medical comorbidities that will preclude safety evaluation of the combination should not be enrolled.\n10. Patients with uncontrolled infection requiring parenteral therapy shall not be enrolled until infection is treated and brought under control (to minimum of requirement of oral antibiotics).\n11. Currently participating in or has planned participation in a study of another investigational agent or device.\n12. Active prior or concurrent malignancy. Such patients for whom the natural history of the malignancy or its treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational schedule are eligible for this study, if approved in writing by the sponsor. Examples of such malignancies include basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and early-stage prostate cancer undergoing watchful waiting. Patients with a completely treated prior malignancy and no evidence of disease for \\>2 years prior to the first dose of ZE74-0282 are eligible.\n13. Patient for whom MRI OR CT imaging of spleen can not be performed on the same imaging platform throughout the study",{"count":91,"type":20},[55],"This study will test an experimental drug called ZE74-0282 in people with certain blood disorders caused by a specific mutation called JAK2 V617F. The main goals are to find the right dose level, to see how safe and tolerable different doses are, how the drug moves through the body, and whether it shows early signs of anti-tumor activity. Participants will receive ZE74-0282 in one of several dose groups. The study is open-label, meaning both the doctor and the participant know which treatment is given. It will take place at multiple centers across different countries. Blood tests and regular check-ups will be done to monitor side effects and measure the effect on the disease.",[26,58],[118,119,120],"JAK2 V617F mutations","polycythemia vera","myelofibrosis","NOT_YET_RECRUITING","2026-04-08",{"date":124,"type":36},"2026-04-14",{"date":126,"type":20},"2026-05-15",{"date":40,"type":20},{"name":129,"class":81},"Eilean Therapeutics",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":21,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":44},"100610800","phase-2-phase-iia-study-on-flonoltinib-maleate-tablets-in-the-treatment-of-patients-with-polycythemia-vera-100610800","NCT07232290","Phase IIa Study on Flonoltinib Maleate Tablets in the Treatment of Patients With Polycythemia Vera","An Open Label, Randomized, Parallel Controlled, Multicenter Phase IIa Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Flonoltinib Maleate Tablets in the Treatment of Hydroxyurea or Interferon Resistant\u002FIntolerant Polycythemia Vera","Inclusion Criteria:\n\n1. Age \\>= 18 years old and gender not limited when signing the informed consent form;\n2. Diagnosed as PV according to WHO standards (2016 edition), and resistant\u002Fintolerant to hydroxyurea or interferon treatment (refer to attachments 1 and 2);\n3. When screening, the peripheral blood primitive cells are 0%;\n4. Meet any of the following criteria and achieve HCT\\\u003C= 45% before randomization\u002Fenrollment:\n\n1)At least 2 venous bloodletting and\u002For apheresis treatments have been performed within 24 weeks prior to screening, with a minimum interval of 4 weeks between each treatment, and at least 1 treatment has occurred within 16 weeks prior to screening; 2)At least one venous bloodletting and\u002For apheresis treatment has been performed within the 16 weeks and HCT\\>45% at the time of screening; 5.When screening, laboratory test indicators meet the following criteria: neutrophil count \\>= 1.0 × 10 \\^ 9\u002FL, platelet count \\>= 100 × 10 \\^ 9\u002FL and \\\u003C= 1000 × 10 \\^ 9\u002FL; ALT and AST\\\u003C= 2.5 × ULN; TBIL\\\u003C=2.0×ULN; Serum creatinine \\\u003C= 1.5 × ULN; 6.ECOG 0-2 points; 7.Can understand and voluntarily sign an informed consent form.\n\nExclusion Criteria:\n\n1. Individuals with allergies or suspected allergies to the test drug and its excipients;\n2. The toxic reactions of previous anti-cancer treatments have not recovered to grade 1 or below (excluding hair loss, blood routine and blood biochemical indicators refer to inclusion criteria 4 and 5), or have not fully recovered from previous surgeries (having undergone major surgery within 4 weeks);\n3. In addition to PV, any other myeloproliferative neoplasms (MPN), including post polycythemia vera myelofibrosis (PPV-MF), may also be present;\n4. Any active infections that require systemic treatment (oral, intravenous, subcutaneous, intramuscular, etc.) during screening;\n5. Patients with swallowing difficulties, chronic diarrhea, or oral absorption disorders are included in the screening process;\n6. Patients with basic diseases that are difficult to control in combination with drug treatment during screening, including but not limited to: diabetes, hypertension , peripheral neuropathy ;\n7. Screening for individuals who have experienced congestive heart failure (NYHA class III or above), unstable angina, myocardial infarction, cerebrovascular accidents with functional impairment, or require treatment for arrhythmia within the past 6 months;\n8. Individuals with QTcF\\>450 ms (male) and QTcF\\>470 ms (female) on electrocardiogram during screening;\n9. Individuals who have experienced active tuberculosis infection within the past year prior to screening, or those whose tuberculosis related test results indicate latent infection during screening;\n10. Patients who have undergone splenectomy or splenic radiotherapy in the past;\n11. When screening, any of the following situations exist: a) Hepatitis B surface antigen (HbsAg) or hepatitis B core antibody (HbcAb) is positive, and HBV-DNA detection is positive or above the upper limit of normal value; b) HCV antibody positive and HCV-RNA detection positive; c) Positive for anti Treponema pallidum antibody (TP Ab) and positive for Treponema pallidum non-specific antibody (PRP or TRUST) detection; d) Positive for Human Immunodeficiency Virus Antibody (HIV Ab);\n12. Individuals with epilepsy or mental illnesses requiring medication during screening (excluding insomnia);\n13. Individuals who have suffered from other malignant tumors within the past 5 years prior to the first administration (excluding cured carcinoma in situ and basal cell carcinoma of the skin);\n14. Patients with congenital or acquired bleeding disorders or active thrombotic disorders during screening;\n15. Combining other serious diseases during screening may affect patient safety or compliance, according to researchers;\n16. Within 2 weeks prior to trial administration or within 5 half lives (whichever is longer), any therapeutic PV drugs have been used, including hydroxyurea, recombinant interferon - α (long-acting recombinant interferon - α treatment needs to be discontinued for 4 weeks), JAK inhibitors (such as Ruxolitinib), 32P (needs to be discontinued for 8 weeks), Busulfan, etc;\n17. Patients who receive treatment with other clinical trial drugs or clinical trial medical devices before screening and have not fully eluted for at least 5 half lives or 1 month (whichever is longer);\n18. Pregnant or lactating women;\n19. Individuals who have the ability to conceive but refuse to use contraceptive measures during the trial period ;and within 6 months after the trial ends;\n20. Vaccination with active or attenuated vaccines within 4 weeks prior to screening;\n21. Researchers believe that there are other factors that are not suitable for participating in the experiment.",{"count":91,"type":20},[93],"This trial adopts an open, randomized, parallel controlled, multicenter clinical trial design planning to enroll patients with polycythemia vera who are resistant\u002Fintolerant to hydroxyurea or interferon。The study divided into two stages: dose exploration stage: three dose groups are tentatively set, with three subjects in each group, totaling nine subjects in each group; Dose extension stage: Based on the safety, efficacy, and pharmacokinetic results of the comprehensive dose exploration stage, 2-3 dose groups are planned to be selected for dose extension trials.",[26],"2026-03-02",{"date":143,"type":36},"2026-03-04",{"date":145,"type":36},"2025-09-23",{"date":147,"type":20},"2028-02-28",{"name":149,"class":81},"Chengdu Zenitar Biomedical Technology Co., Ltd",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":159,"phases":4,"briefSummary":160,"conditions":161,"keywords":211,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":252},"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":158,"type":20},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.",[162,163,26,164,165,62,166,58,167,168,169,170,171,172,173,174,175,176,177,178,179,60,180,181,182,183,61,184,185,186,187,188,189,190,191,59,192,193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209,210],"Polycythemia Vera","ET (Essential Thrombocythemia)","Essential Thrombocythemia (ET)","Primary Myelofibrosis (MF)","Myelofibrosis","Myelofibrosis, Primary","Myelofibrosis, Post ET","Myelofibrosis, Post PV","Myelofibrosis (PMF)","Myelofibrosis，MF","Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis","Myelofibrosis Due to and Following Polycythemia Vera","Myelofibrosis Transformation in Essential Thrombocythemia","Myelofibrosis With High Molecular Risk Mutations","MF","Secondary Myelofibrosis","Secondary Myelofibrosis in Myeloproliferative Disease","Secondary Myelofibrosis (Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia 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 (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 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",[194,162,212,177,213,189,198,214,215,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230,231,232,233,234,235,236,237,238,239,240,241,242],"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","2026-01-15",{"date":245,"type":36},"2026-01-23",{"date":247,"type":36},"2025-09-26",{"date":249,"type":20},"2035-09-08",{"name":251,"class":43},"MPN Research Foundation",2,{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":261,"enrollmentInfo":262,"targetDuration":4,"studyType":21,"phases":264,"briefSummary":265,"conditions":266,"keywords":268,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":44},"100619163","potential-biological-and-physiological-determinants-for-exercice-in-patients-with-polycythemia-vera-100619163","NCT07341048","Potential Biological and Physiological Determinants for Exercice in Patients With Polycythemia Vera","Characterization of Exercise Intolerance in Patients With Polycythemia Vera: Study of Potential Biological and Physiological Determinants.","ACTIVAQ","Inclusion Criteria:\n\n* Patient aged at least 18 years and under 70.\n* Patient followed for a diagnosis of Polycytemia vera (confirmed JAK2 V617F mutation) and who were prescribed a CPET because of their wish to resume regular physical activity.\n* Patient affiliated with or benefiting from a social security scheme.\n\nExclusion Criteria:\n\n* Any known history of heart disease or chronic respiratory illness likely to affect VO₂max independently of Polycytemia vera (e.g., asthma), according to the investigator's judgment.\n* Any known history of major thromboembolic complication, according to the investigator's judgment.\n* Body mass index (BMI) greater than 35, according to the investigator's judgment.\n* Participation in another interventional research protocol that may interfere with the present study, according to the investigator's judgment.\n* Adult subject under legal protection measures (guardianship, curatorship).\n* Subject currently receiving psychiatric care.\n* Subject deprived of liberty by judicial or administrative decision.","70 Years",{"count":263,"type":20},54,[23],"Polycythemia vera (PV) is a rare haematological disorder characterized by an excessive production of red blood cells, associated with the somatic JAK2 V617F mutation. Clinical manifestations are varied and often include exercise intolerance but the underlying mechanisms remain poorly understood.\n\nPhysical activity is recommended in the management of chronic diseases, but it must be tailored to the physiological profile of the patient. A cardiopulmonary exercise test (CPET) is essential to ensure safety, detect possible contraindications, and assess maximal oxygen uptake (VO₂max), a key indicator of aerobic performance.\n\nThis prospective, experimental, non-randomized study will include patients with PV followed at Lyon Sud University Hospital and for which a CPET is scheduled in their routine clinical follow-up. The primary objective is to compare VO₂max between two groups of patients: moderate (\\\u003C10%) versus marked (≥10%) extent of blood viscosity increase after the completion of the CPET. The main hypothesis is that a significant increase in blood viscosity during exercise (≥10%) is a major limiting factor in oxygen transport and leads to a reduced VO₂max, reflecting impaired exercise tolerance.\n\nSecondary analyses will focus on hemorheological parameters, tissue oxygenation, and cardiorespiratory and metabolic responses. The study aims to better understand the biological and physiological determinants of exercise intolerance in this population.",[267,26],"Polycythemia",[269,270],"Blood viscosity","polycythemia","2026-01-14",{"date":243,"type":36},{"date":274,"type":20},"2026-01",{"date":276,"type":20},"2027-05",{"name":278,"class":43},"Hospices Civils de Lyon",{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":21,"phases":287,"briefSummary":288,"conditions":289,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":44},"100557679","phase-2-methotrexate-in-myeloproliferative-neoplasms-treatmore-trial-100557679","NCT06541249","MethoTRExATE in MyelOpRolifErative Neoplasms (TREATMORE) Trial","TREATMORE","Inclusion Criteria\n\n* Be ≥18 years of age at time of signing the informed consent form (ICF)\n* Must voluntarily sign ICF and be willing and able to adhere to the study visit schedule and all protocol requirements\n* Have a pathologically confirmed diagnosis of PV, ET, PMF, post-ET-MF, or post-PV-MF as per WHO diagnostic criteria\n* Participants with MF may have low, intermediate 1, intermediate 2, or high-risk disease by Dynamic International Prognostic Scoring System (DIPSS). Participants with PV and ET with both low- and high-risk disease may be included.\n* Must have received at least 12 weeks of current MPN therapy at stable doses and have persistent clinical burden and\u002For cytologic abnormalities as defined by the following:\n\n  * Clinical burden is defined as MPN-SAF TSS \\>12 points and\u002For palpable spleen of ≥5cm\n  * Cytologic abnormalities include the following for each disease state:\n\n    * MF:\n\n      * Persistent leukocytosis as defined by WBC \\>12 x 109\u002FL\n    * PV:\n\n      * Persistent therapeutic phlebotomy dependence (\\>2 phlebotomies within 24 weeks of screening, and \\>1 phlebotomy within 16 weeks of screening, as defined in the PROUD-PV studies) for a goal HCT \\\u003C45% and\u002For\n      * Leukocytosis as defined by WBC \\>12 x 109\u002FL and\u002For\n      * Thrombocytosis defined as platelet count \\>500 x 109\u002FL\n    * ET:\n\n      * Persistent leukocytosis as defined by WBC \\>12 x 109\u002FL and\u002For\n      * Thrombocytosis defined as platelet count \\>500 x 109\u002FL\n  * Permitted concurrent MPN therapies include: aspirin, hydroxyurea, anagrelide, ropeginterferon alfa-2b, peginterferon alfa-2a, erythropoiesis-stimulating agents, phlebotomy, and\u002For ruxolitinib.\n\n    * A stable dose is defined as 12 weeks of treatment without a change in dosing\n    * Patients with myelofibrosis must be on stable dose of ruxolitinib\n* Must have adequate organ function as demonstrated by the following:\n\n  * AST, ALT \\\u003C3x upper limit of normal (ULN) and no known history of cirrhosis\n  * Total bilirubin \\\u003C3mg\u002FdL\n  * Creatinine clearance (CrCl) \\>40 mL\u002Fmin as estimated with the Cockcroft-Gault equation\n  * Baseline platelet count \\>50 x 109\u002FL for MF and \\>150 x 109\u002FL for ET\u002FPV\n  * Baseline absolute neutrophil count (ANC) \\>1000\n  * Peripheral blood blast count \\\u003C10%\n* ECOG performance status ≤2\n* Life expectancy of at least six months\n* Female participants of childbearing potential must have a negative serum pregnancy test at screening and Cycle 1 Day 1 and must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\n\n  * Recommended methods of birth control are:\n\n    * The consistent use of an approved hormonal contraception (birth control pill\u002Fpatches, rings), an intrauterine device (IUD), contraceptive injection (Depo-Provera), double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), sexual abstinence (no sexual intercourse), or sterilization\n  * A woman of childbearing potential is any woman (regardless of sexual orientation, having undergone a tubal litigation, or remaining celibate by choice) who meets the following criteria:\n\n    * Has not undergone a hysterectomy or bilateral oophorectomy; or\n    * Has not been naturally postmenopausal for at least 12 consecutive months\n* Male participants must agree to use an adequate method of contraception and must not father a child or donate sperm starting with the first dose of study therapy through 120 days after the last dose of study therapy\n\nExclusion Criteria\n\n* Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment\n* Prescribed MTX for another indication\n* History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months\n* Have other invasive malignancies within the last 3 years, except non-melanoma skin cancer and localized, cured prostate and cervical cancer\n* Have moderate or severe cardiovascular disease as defined by the following:\n\n  * Have cardiac disease, including a myocardial infarction within 6 months prior to study entry, unstable angina pectoris, New York Heart Association Class III\u002FIV congestive heart failure, or uncontrolled hypertension\n  * Have documented major ECG abnormalities (not responding to medical treatments)\n* Be an organ transplant recipient other than bone marrow transplant\n* Presence of active serious infection\n* Have a known history B, or untreated hepatitis C infection\n* Have a known history of pulmonary fibrosis, interstitial pneumonitis\n* Have a known history of chronic pericardial effusions, pleural effusions, or ascites\n* Have a known history of cirrhosis, or current heavy alcohol consumption\n* Have impairment of gastrointestinal function or gastrointestinal disease that could significantly alter the absorption of MTX, including any unresolved nausea, vomiting, or diarrhea \\> CTCAE v5.0 grade 1\n* Have known history of tuberculosis or severe fungal infection\n* Is receiving specific concomitant medications that are contraindicated with MTX.\n* Women who are pregnant or lactating, or plan to become pregnant during trial period\n* Have any serious, unstable medical or psychiatric condition that would prevent (as judged by the Investigator) the participant from signing the informed consent form or any condition, including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he\u002Fshe were to participate in the study or confounds the ability to interpret data from the study\n* Is or has an immediate family member (e.g., spouse, parent\u002Flegal guardian, sibling, or child) who is investigational site or sponsor staff directly involved with this trial, unless prospective IRB approval (by chair or designee) is given allowing exception to this criterion for a specific participant",{"count":263,"type":20},[93],"Low-dose MTX is a widely used, inexpensive, and safe therapy used for decades and is well tolerated by patients with rheumatologic diseases. Recently, it was identified as a type 2 JAK inhibitor. If MTX proves to be safe and tolerable with a signal of clinical activity, this could have a significant benefit to patients with MPNs. Beyond the potential benefit of adding a type 2 JAK inhibitor to current therapy, this could signal the need to study MTX in MPNs further as a monotherapy. Discovering MTX as safe and clinically effective in MPNs could be profound on both a public health and global health scale for patients who are uninsured and cannot afford more expensive novel JAK inhibitors, or for those in countries where JAK inhibitors are not available. Accordingly, the research team deems it reasonable and prudent to assess the safety and efficacy of MTX in addition to current therapy for patients with MPN. The research team will evaluate patients for spleen responses, symptom responses, and cytologic responses. Correlative data will evaluate pharmacokinetic and disease modifying activity of MTX in MPNs to inform future clinical trials.",[26,164,58],"2025-12-14",{"date":292,"type":36},"2025-12-17",{"date":294,"type":36},"2024-10-02",{"date":296,"type":20},"2027-12",{"name":298,"class":43},"Icahn School of Medicine at Mount Sinai",{"id":300,"slug":301,"hasResults":11,"nctId":302,"briefTitle":303,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":11,"sex":16,"minAge":305,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":306,"phases":4,"briefSummary":307,"conditions":308,"keywords":313,"overallStatus":321,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":325,"locationsCount":4},"100419739","managed-access-programs-for-inc424-ruxolitinib-100419739","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.","2 Years","EXPANDED_ACCESS","The purpose of this registration is to list Managed Access Programs (MAPs) related to INC424, Ruxolitinib",[62,309,204,310,26,311,312],"Post Polycythemia Myelofibrosis (PPV MF)","Severe\u002FVery Severe COVID-19 Illness","Steroid Refractory Acute Graft Versus Host Disease (SR aGVHD)","Steroid Refractory Chronic Graft Versus Host Disease (SR cGVHD)",[314,315,62,309,204,316,26,317,318,319,320],"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":324,"type":36},"2025-11-18",{"name":326,"class":81},"Novartis Pharmaceuticals",{"id":328,"slug":329,"hasResults":11,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":333,"eligibilityCriteria":334,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":335,"targetDuration":337,"studyType":159,"phases":4,"briefSummary":338,"conditions":339,"keywords":345,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":44},"100576482","evaluation-of-erythrocytosis-prospective-cohort-study-100576482","NCT06785870","EVAluation of Erythrocytosis PRospEctive Cohort STudy","Evaluation of Erythrocytosis Prospective Cohort Study (EVEREST): Diagnosis, Management and Longitudinal Outcomes in Patients with Elevated Hemoglobin","EVEREST","Inclusion Criteria:\n\n1. Adult patients (\\>=18 years) referred to hematology clinics at London Health Sciences Centre with hemoglobin levels \\>=165 g\u002FL in males or \\>=160 g\u002FL in females.\n2. Patients capable of providing informed consent.\n3. Age \\>= 18 years.\n\nExclusion Criteria:\n\n1. Patients \\\u003C18 years.\n2. Patients without erythrocytosis.\n3. Patients incapable of providing informed consent.",{"count":336,"type":20},1500,"5 Years","The EValuation of ERythrocytosis pRospEctive cohort STudy (EVEREST) is a prospective study designed to shed light on these key questions in the diagnosis, management, and clinical outcomes in patients with elevated hemoglobin (erythrocytosis). This longitudinal, prospective study will generate high quality data that can help inform the optimal approach to diagnosis and management in this patient population.",[340,267,341,162,342,26,343,344],"Erythrocytosis","Polycythemia Secondary","Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase","Polycythemia; Familial","Polycythemia, Primary",[346,226,340,267,347,348,349,350],"Prospective","Patient Registry","Diagnosis","Management","Outcomes","2025-01-19",{"date":353,"type":36},"2025-01-21",{"date":355,"type":20},"2025-02-01",{"date":357,"type":20},"2030-12-31",{"name":359,"class":43},"Cyrus Hsia",{"id":361,"slug":362,"hasResults":11,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":4,"eligibilityCriteria":366,"healthyVolunteers":11,"sex":16,"minAge":367,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":21,"phases":370,"briefSummary":372,"conditions":373,"keywords":374,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":384},"100412787","phase-3-extension-study-of-p1101-after-completion-of-phase-2-study-in-pv-patients-or-phase-3-study-in-et-patients-100412787","NCT04655092","Extension Study of P1101 After Completion of Phase 2 Study in PV Patients or Phase 3 Study in ET Patients","Extension Study of P1101 in Japanese Patients Who Have Completed Phase 2 Single Arm Study in Polycythemia Vera (PV) Patients (Study A19-201) or Phase 3 Study in Essential Thrombocythemia (ET) Patients (Study P1101 ET)","Inclusion Criteria:\n\n* Patients who have completed the 52-week treatment duration in Study A19-201 and are considered by the investigator or sub investigator to be eligible for participation in this study\n* Patients who have given written informed consent to participate in this study\n\nExclusion Criteria:\n\n* Patients who are considered by the investigator or sub investigator to be ineligible for continued treatment with P1101","20 Years",{"count":369,"type":20},67,[371],"PHASE3","This is a Phase 3 open-label, multicenter, single arm study designed to evaluate the efficacy and safety and tolerability of P1101 patient with PV or ET in long-term.",[26],[194],"2024-11-06",{"date":377,"type":36},"2024-11-08",{"date":379,"type":36},"2021-01-19",{"date":381,"type":20},"2026-06-30",{"name":383,"class":81},"PharmaEssentia Japan K.K.",6]