[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"polycythemia-vera\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:polycythemia-vera":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,29,0,25,[9,42,67,91,131,157,182,206,235,263,287,386,412,435,458,477,501,534,557,586,612,633,653,687,712],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100625948","phase-3-intrepid-a-study-of-sapablursen-evaluating-the-safety-and-efficacy-in-participants-with-polycythemia-vera-pv-100625948",false,"NCT07429266","INTREPID: A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV)","A Phase 3 Randomized, Double-blind, Placebo-controlled Global Study of Sapablursen in Polycythemia Vera","INTREPID","Inclusion Criteria:\n\n1. Meet revised 2022 World Health Organization (WHO) and 2022 International Consensus Classification criteria for the diagnosis of PV.\n2. Participants must be phlebotomy-dependent.\n3. Hct less than (\\\u003C) 45% at study start.\n4. Participants receiving Cytoreduction therapy (CRT) must be on a stable regimen at study start.\n5. Adequate organ function and electrolytes.\n\nExclusion Criteria:\n\n1. Prior treatment of PV with Transmembrane serine protease 6 (TMPRSS6) inhibitors, including sapablursen, or hepcidin mimetics.\n2. Clinically significant thrombosis (eg, myocardial infarction, stroke, deep vein thrombosis or splenic vein thrombosis) within 1 month prior to randomization.\n3. Participants who require phlebotomy at Hct levels \\\u003C45%.\n4. Meet the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment.\n5. Any serious or unstable medical condition or uncontrolled psychiatric condition that would interfere with their ability to comply with study requirements.","ALL","18 Years",{"count":21,"type":22},250,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of sapablursen when added on to current standard of care (SOC) for Polycythemia Vera (PV) therapy. The study will be conducted in three sequential parts (Part 1a blinded treatment, Part 1b open-label treatment, \\& Part 2 long-term extension). Participants may receive treatment for up to 156 weeks.",[28],"Polycythemia Vera","RECRUITING","2026-06-28",{"date":32,"type":33},"2026-06-30","ACTUAL",{"date":35,"type":33},"2026-05-25",{"date":37,"type":22},"2031-01",{"name":39,"class":40},"Ono Pharmaceutical Co., Ltd.","INDUSTRY",5,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100641830","phase-2-a-study-of-rusfertide-in-japanese-adults-with-polycythemia-vera-100641830","NCT07648030","A Study of Rusfertide in Japanese Adults With Polycythemia Vera","A Phase 2 Open-label Trial to Evaluate the Efficacy and Safety of Rusfertide in Japanese Patients With Polycythemia Vera","Inclusion Criteria:\n\n1. Japanese male and female participants aged 18 years or older at the time of signing informed consent.\n2. Participant understands the trial procedures, is willing and able to adhere to trial requirements and agrees to participate in the trial by giving written informed consent.\n3. Meet revised 2016 WHO criteria for the diagnosis of PV.\n4. Phlebotomy requiring defined as ALL of the following:\n\n   1. At least 3 phlebotomies due to inadequate hematocrit control in 28 weeks before trial intervention or at least 5 phlebotomies due to inadequate hematocrit control in 1 year before trial intervention, and\n   2. Last phlebotomy due to inadequate hematocrit control within 3 months before trial intervention, and\n   3. No phlebotomy within 6 days prior to trial intervention (do not include day of phlebotomy and day of trial intervention in the 6-day count).\n\n   Note: Phlebotomies performed within an 8-day period will be counted as a single phlebotomy.\n5. Hematology test values at screening:\n\n   1. Hematocrit \\\u003C45%\n   2. WBC 4,000\u002FµL to 20,000\u002FµL (inclusive), and\n   3. Platelets 100,000\u002FµL to 1,000,000\u002FµL (inclusive).\n6. ECOG performance status 0, 1 or 2.\n7. WOCBP agree to use at least 1 form of highly effective contraception during the trial and for 30 days after the last dose of trial intervention.\n8. A female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the trial and for a period of 30 days after receiving the last dose of trial medication.\n9. A fertile man agree to use a condom, preferably combined with at least 1 form of acceptable contraception for any WOCBP partner(s) during the trial and for 90 days after the last dose of trial intervention.\n10. A male participant must agree not to donate sperm for the purpose of reproduction during the trial and for a minimum of 90 days after receiving the last dose.\n11. Participants receiving CRT at trial intervention must be on a stable PV therapy regimen as follows:\n\n    1. Hydroxyurea - at least 8 weeks\n    2. JAK inhibitor - at least 8 weeks\n    3. Interferon - at least 24 weeks. Note: A \"stable dose regimen\" of CRT does not mean an unchanged dose regimen. Temporary adjustments in dose regimen or temporary suspension of dosing are allowed. However, the total weekly dose of hydroxyurea and JAK inhibitor or total monthly dose of interferon may not be higher at trial intervention than the dose at the beginning of the pre-trial intervention observation period. The pre-trial intervention observation period is 8 weeks for hydroxyurea and JAK inhibitor and 24 weeks for interferon.\n12. Participants treated with phlebotomy alone at trial intervention must have stopped:\n\n    1. Hydroxyurea at least 8 weeks before trial intervention\n    2. JAK inhibitor at least 8 weeks before trial intervention\n    3. Interferon at least 24 weeks before trial intervention.\n\nExclusion Criteria:\n\n1. Clinically meaningful laboratory abnormalities at Screening including, but not limited to:\n\n   1. eGFR \\\u003C15 mL\u002Fmin\u002F1.73 m\\^2 as determined by Japanese Society of Nephrology. Calculated by the correction formula for Japanese\\*\n\n      \\*eGFR=194×(serum creatinine value)-1.094×(age)-0.287×(sex correction factor), Sex correction factor: 0.739 in female (Japanese Society of Nephrology,2023).\n   2. ALT or AST ≥2.5×ULN\n   3. Total bilirubin \\>1.5×ULN. Note: Screening laboratory tests with abnormal results (if considered by the investigator to be transient and inconsistent with the participant's clinical condition) may be repeated within the screening window to confirm abnormal results. If results return to protocol acceptable limits within the screening period, the participant may enter the trial. Use local labs for all eligibility lab tests.\n2. Participants who require phlebotomy at hematocrit levels lower than 45%.\n3. Pregnant females will be ineligible to participate in this trial if, despite a negative pregnancy test, the investigator determines that based on interview, clinical assessment, or other relevant information that the individual may be in the very early stages of pregnancy.\n4. Is capable of breastfeeding but does not agree to forego breastfeeding from the first dose of trial intervention through 30 days after the last dose of trial intervention.\n5. Clinically significant thrombosis (eg, deep vein thrombosis or splenic vein thrombosis) within 2 months prior to trial intervention.\n6. Active or chronic bleeding within 2 months prior to trial intervention.\n7. Meets the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT).\n8. Any infection requiring systemic therapy within 1 month of dosing except controlled: HIV, hepatitis B, and hepatitis C. Prophylactic therapies are allowed.\n9. Any serious or unstable medical condition (eg, poorly controlled HIV infection) or uncontrolled psychiatric condition as judged by the investigator that would impair the participant's ability to participate in the trial.\n10. Major surgical procedure within 2 months prior to trial intervention unless the participant has fully recovered from surgery or planned major elective surgery during the trial.\n11. History of invasive malignancies within the last 5 years, except\n\n    1. localized cured cancer (eg, prostate cancer and cervical cancer)\n    2. localized cured in situ or stage 1 squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or in situ melanoma of the skin.\n12. 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 the required dermatology examination at screening unless the cancer is adequately treated (ie, treatment that is expected to be curative, such as Mohs surgery) before trial intervention. Note: Suspicious lesions should be biopsied and results available before trial intervention.\n13. Participants with active alcohol or drug addiction that would interfere with their ability to comply with trial requirements.\n14. Participants who do not complete at least 4 days of MFSAF v4.0 assessments within 1 week prior to trial intervention.\n15. Receipt of an investigational agent within 2 months or 5 half-lives, whichever is longer, prior to trial intervention.\n16. Received busulfan within 7 months prior to screening.\n17. Participants with hypersensitivity to rusfertide or to any of the excipients.\n18. Participants with any lesion or mass detected by physical examination or imaging during screening that is suspicious for malignancy unless evaluated and assessed to be not malignant.",{"count":50,"type":22},9,[52],"PHASE2","Polycythemia vera (PV) is a rare blood cancer in which the body makes too many red blood cells. This can make the blood thicker and may increase the risk of serious health problems such as blood clots. Many people with PV need regular phlebotomy, which is a procedure to remove blood, to help keep their hematocrit level under control. Hematocrit is the proportion of red blood cells in the blood.\n\nThe main aim of this study is to evaluate whether rusfertide helps Japanese participants with PV keep their hematocrit under control and avoid the need for phlebotomy. All participants in this study will receive rusfertide. This study is open-label, which means both the participants and the study team will know what treatment is being given.\n\nParticipants will be followed for up to about 244 weeks, including a screening period, a 52-week initial treatment period, a long-term extension period, and a 4-week safety follow-up period.",[28],[56],"Drug Therapy","NOT_YET_RECRUITING","2026-06-10",{"date":60,"type":33},"2026-06-15",{"date":62,"type":22},"2026-06-23",{"date":64,"type":22},"2030-05-17",{"name":66,"class":40},"Takeda",{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":23,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":90},"100371448","phase-3-mithridate-ruxolitinib-versus-hydroxycarbamide-or-interferon-as-first-line-therapy-in-high-risk-polycythemia-vera-100371448","NCT04116502","MITHRIDATE: Ruxolitinib Versus Hydroxycarbamide or Interferon as First Line Therapy in High Risk Polycythemia Vera","A Phase III, Randomised, Open-label, Multicenter International Trial Comparing Ruxolitinib With Either HydRoxycarbamIDe or Interferon Alpha as First Line ThErapy for High Risk Polycythemia Vera","MITHRIDATE","Population:\n\nHigh risk PV defined as WBC \\>11 x 10\\^9\u002Fl\\* AND at least ONE of the following\n\n* Age \\>60 years\n* Prior thrombosis or haemorrhage\n* Platelet count \\>1000 x 10\\^9\u002Fl\\*\n* Hypertension or diabetes requiring pharmacological therapy (\\*At any time since diagnosis)\n\nInclusion Criteria:\n\n1. Patient ≥18 years of age\n2. Diagnosis of PV meeting the WHO criteria within the past 15 years\n3. Meets criteria of high risk\\* PV (see above for specific population)\n4. Patients must have a screening haemoglobin of \\>8g\u002Fdl\n5. Patients may have received antiplatelet agents and venesection\n6. Patients may have received ONE cytoreductive therapy for PV less than 10 years (BUT they should not be resistant or intolerant to that therapy)\n7. Able to provide written informed consent\n\nExclusion Criteria:\n\n1. Diagnosis of PV \\> 15 years previously\n2. Absence of JAK-2 mutation\n3. Patients with any contraindications to any of the investigational medical products\n4. Treatment with \\>1 cytoreductive therapy OR a cytoreductive treatment duration exceeding 10 years OR resistance\u002Fintolerance to that therapy\n5. Active infection including Human Immunodeficiency Virus (HIV), hepatitis B, hepatitis C, autoimmune hepatitis, Tuberculosis\n6. Pregnant or lactating patients (Women of childbearing potential must have a negative urine or blood Human Chorionic Gonadotropin pregnancy test prior to trial entry)\n7. Patients with lactose allergies, hypersensitivities, or rare hereditary problems, of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption\n8. Patients with uncontrolled neuropsychiatric disorders\n9. Patients with uncontrolled cutaneous cancers\n10. Patients and partners not prepared to adopt highly effective contraception measures (if sexually active) whilst on treatment and for at least 6 months after completion of study medication\n11. ECOG Performance Status Score ≥ 3\n12. Uncontrolled rapid or paroxysmal atrial fibrillation, uncontrolled or unstable angina, recent (within the last 6 months) myocardial infarction or acute coronary syndrome or any clinically significant cardiac disease \\> NYHA ( New York Heart Association) Class II\n13. Patients who have transformed to myelofibrosis\n14. Previous treatment with ruxolitinib\n15. Previous (within the last 12 months) or current platelet count \\\u003C100 x 109\u002FL or neutrophil count \\\u003C 1 x 109\u002FL not due to therapy\n16. Inadequate liver function as defined by ALT\u002FAST \\>2.0 x ULN\n17. Inadequate renal function as defined by eGFR \\\u003C 30 mls\u002Fmin\n18. Unable to give informed consent\n\n    Additional Exclusion Criteria for France Only\n19. All women of childbearing potential (as per Appendix 8 definition)\n20. No affiliation with the French healthcare system\n21. Persons under psychiatric care that would impede understanding of informed consent and optimal treatment and follow-up\n22. Adults subject to a legal protection measure (guardianship, curatorship and safeguard of justice)\n23. Patients deprived of their liberty by a judicial or administrative decision",{"count":76,"type":22},586,[25],"The trial will be a phase III, randomised-controlled, multi-centre, international, open-label trial consisting of ruxolitinib versus best available therapy, where best available therapy is a choice of interferon alpha, any formulation permitted (IFN) or hydroxycarbamide (HC), and which will be elected by the Investigator prior to randomisation.",[28],"2026-04-27",{"date":82,"type":33},"2026-04-28",{"date":84,"type":33},"2019-10-25",{"date":86,"type":22},"2030-04-01",{"name":88,"class":89},"University of Birmingham","OTHER",47,{"id":92,"slug":93,"hasResults":12,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":23,"phases":100,"briefSummary":102,"conditions":103,"keywords":108,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100632842","energia-personalized-exercise-program-for-fatigue-in-patients-with-myeloproliferative-neoplasms-and-chronic-myeloid-leukemia-100632842","NCT07518940","ENERGIA: Personalized Exercise Program for Fatigue in Patients With Myeloproliferative Neoplasms and Chronic Myeloid Leukemia","ENERGIA: Exercise in Rare Hematologic Diseases With Individualized and Adapted Management","ENERGIA","Inclusion Criteria:\n\nAge ≥18 years Confirmed diagnosis of myeloproliferative neoplasm (polycythemia vera, essential thrombocythemia, low-risk primary myelofibrosis) or chronic myeloid leukemia according to WHO criteria Clinical and therapeutic stability for at least 8 weeks prior to enrollment Presence of clinically relevant fatigue as assessed by validated disease-specific questionnaires General clinical condition compatible with participation in a supervised exercise program of at least moderate intensity Absence of contraindications to cardiopulmonary exercise testing No participation in structured exercise or rehabilitation programs within the previous 3 months Minimum hematological safety parameters (hemoglobin \\>10 g\u002FdL; platelets \\>100,000 × 10⁹\u002FL) Ability to understand and comply with study procedures Provision of written informed consent\n\nExclusion Criteria:\n\nUnstable cardiovascular conditions (including uncontrolled heart failure, recent myocardial ischemia, symptomatic ventricular arrhythmias, or unexplained syncope) Thrombotic or hemorrhagic events within the previous 3 months Active acute or chronic infections Severe orthopedic or neurological conditions limiting the ability to perform exercise or functional testing Severe systemic diseases (e.g., advanced renal or hepatic failure, active secondary malignancy, uncontrolled psychiatric disorders) Any clinical condition that, in the investigator's judgment, may compromise safety or adherence to the protocol Indication for a primary structured rehabilitation program based on physiatric evaluation",{"count":7,"type":22},[101],"NA","This study evaluates whether a personalized, supervised exercise program can improve fatigue and physical function in patients with myeloproliferative neoplasms (MPN) and chronic myeloid leukemia (CML). Although many patients achieve good disease control with modern therapies, they often experience persistent symptoms such as fatigue that significantly affect daily life.\n\nParticipants will take part in a 12-week exercise program that includes aerobic and resistance training, tailored to their individual fitness level and clinical condition. The program consists of two supervised sessions per week, along with additional home-based aerobic activity. Before and after the program, participants will undergo comprehensive assessments, including cardiopulmonary exercise testing, physical function tests, questionnaires on fatigue and quality of life, and blood sample collection.\n\nThe study aims to determine whether this type of exercise program is feasible and safe, and whether it can reduce fatigue and improve physical capacity, quality of life, and biological markers related to inflammation and metabolism. Participants will also be followed after the intervention to evaluate whether the benefits are maintained over time.",[104,28,105,106,107],"Myeloproliferative Disease","Thrombocythemia Essential","Myelofibrosis, Primary","Chronic Myeloid Leukemia (CML)",[109,110,111,112,113,114,115,116,117,118,119,120],"Myeloproliferative Neoplasms;","Chronic Myeloid Leukemia","Exercise Intervention","Cancer-Related Fatigue","Fatigability","Physical Activity","Cardiorespiratory Fitness","Quality of Life","physical exercise","Immunometabolism","Metabolomics","Feasibility","2026-04-01",{"date":123,"type":33},"2026-04-09",{"date":125,"type":22},"2026-08-01",{"date":127,"type":22},"2027-12-31",{"name":129,"class":89},"Carmen Fava",1,{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":23,"phases":140,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":156},"100543112","phase-3-a-study-to-evaluate-safety-and-efficacy-of-bomedemstat-mk-3543-017-100543112","NCT06351631","A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)","A Multicenter, Open-Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for the Treatment of Participants Enrolled in a Prior Bomedemstat Clinical Study","Inclusion Criteria:\n\n* Is from a bomedemstat study sponsored by Imago BioSciences, Inc. (a subsidiary of Merck \\& Co., Inc.) or MSD, and established by the Sponsor as MK-3543-017 ready\n* Has received at least 6 months of treatment with bomedemstat in the IMG-7289-202\u002FMK-3543-005 study, while safely tolerating bomedemstat, and receiving clinical benefit from its use in the estimation of the investigator\n* ET and PV participants from established feeder studies other than IMG-7289- 202\u002FMK-3543-005 must have achieved confirmed hematologic remission, must be safely tolerating bomedemstat, and must be receiving clinical benefit from its use in the estimation of the investigator\n* Is not currently on a dose hold\n* Participant must be able to swallow oral medication and follow instructions for at-home dosing of bomedemstat\n\nExclusion Criteria:\n\n* Has received prohibited concomitant medications\n* Ongoing or planned participation in another investigational study\n* Has noncompliance in prior bomedemstat study receiving \\\u003C90% of assigned doses excluding suspensions or holds as assigned by the investigator",{"count":139,"type":22},400,[25],"The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria:\n\n* Participants from the IMG-7289-202\u002FMK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat;\n* Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202\u002FMK-3543-005 must have achieved confirmed hematologic remission.\n\nNo hypothesis testing will be conducted in this study.",[143,144,145,146,147,28],"Thrombocythemia, Essential","Primary Myelofibrosis","Myelofibrosis","Post-polycythemia Vera Myelofibrosis","Post-essential Thrombocythemia Myelofibrosis",{"date":149,"type":33},"2026-04-02",{"date":151,"type":33},"2024-05-23",{"date":153,"type":22},"2034-12-04",{"name":155,"class":40},"Merck Sharp & Dohme LLC",21,{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":23,"phases":166,"briefSummary":167,"conditions":168,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":181},"100520970","phase-2-curcumin-to-improve-inflammation-and-symptoms-in-patients-with-clonal-cytopenia-of-undetermined-significance-low-risk-myelodysplastic-syndrome-and-myeloproliferative-neoplasms-100520970","NCT06063486","Curcumin to Improve Inflammation and Symptoms in Patients With Clonal Cytopenia of Undetermined Significance, Low Risk Myelodysplastic Syndrome, and Myeloproliferative Neoplasms","A Phase 2, Double-blind, Randomized Study to Compare the Effect of Curcumin Versus Placebo on Inflammatory Cytokines, Symptoms and Disease Parameters in Clonal Cytopenia of Undetermined Significance (CCUS), Low-Risk Myelodysplastic Syndrome (LR-MDS), and Myeloproliferative Neoplasms (MPNs)","Inclusion Criteria:\n\n* Age \\>= 18\n* Eastern Cooperative Oncology Group (ECOG) =\\\u003C 2\n* Ability to understand and willingness to sign a written informed consent\n* Diagnosis of polycythemia vera (PV), essential thrombocytosis (ET) or myelofibrosis (MF) per World Health Organization (WHO) 2016 diagnostic criteria\n\n  * Presence of at least one symptom measurable using the MPN-\u002FSymptom Assessment Form (SAF) with a severity greater than 3\n  * MPN patients determined to have stable disease undergoing surveillance and unlikely to require initiation of new cytoreductive therapy (i.e., hydroxyurea, ruxotinib, interferon within the study period); patients on a stable dose of hydroxyurea for at least 6 months who meet the other inclusion\u002Fexclusion criteria may be included\n* A diagnosis of CCUS or LR-MDS\n\n  * CCUS defined as persistent cytopenia for \\> 6 months (hemoglobin \\[Hgb\\] \\\u003C 11.3 g\u002FdL \\[7 mmol\u002FL\\] in women and Hgb \\\u003C 12.9 g\u002FdL \\[8 mmol\u002FL\\] in men, platelet \\\u003C 150 x 10\\^9\u002FL or neutrophils \\\u003C 1.8 x 10\\^9\u002FL), normal cytogenetics, presence of detectable MDS associated mutations and bone marrow morphology non-diagnostic of MDS or any other malignancies\n  * LR-MDS as defined by WHO 2016 diagnosis criteria\n  * Minimum baseline symptom score of 25 in the fatigue section of the symptom questionnaire\n\nExclusion Criteria:\n\n* Patients with intake of curcumin as a dietary supplement, including multivitamin and unwillingness to quit more than 24 hours before study start\n* Patients with inability to understand and adhere to information given\n* Patients receiving active treatment for another malignancy except with hormonal therapy for a malignancy considered to be in remission or growth factors (erythropoietin, granulocyte colony-stimulating factor \\[G-CSF\\] and luspatercept)\n* Patients with intermediate or high-risk MDS\n* Patients must not be pregnant or nursing\n* Patients must not be on any oral or intravenous steroid or any other anti-inflammatories (ibuprofen \\> 200mg\u002Fweek or 400mg\u002Fmonth, naproxen of any dose, \\> 325mg aspirin daily, any herbal anti-inflammatory concoction of any dose)",{"count":165,"type":22},30,[52],"This phase II trial evaluates how a curcumin supplement (C3 complex\u002FBioperine) changes the inflammatory response and symptomatology in patients with clonal cytopenia of undetermined significance (CCUS), low risk myelodysplastic syndrome (LR-MDS), and myeloproliferative neoplasms (MPN). Chronic inflammation drives disease development and contributes to symptoms experienced by patients with CCUS, LR-MDS, and MPN. Curcumin has been shown to have anti-inflammatory and anti-cancer properties and has been studied in various chronic illnesses and hematologic diseases.",[169,170,171,145,28],"Clonal Cytopenia of Undetermined Significance","Essential Thrombocythemia","Myelodysplastic Syndrome","2026-03-24",{"date":174,"type":33},"2026-03-27",{"date":176,"type":33},"2024-03-01",{"date":178,"type":22},"2027-03-01",{"name":180,"class":89},"University of Southern California",2,{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":23,"phases":192,"briefSummary":193,"conditions":194,"keywords":195,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":205},"100523284","phase-3-study-on-efficacy-and-safety-of-givinostat-versus-hydroxyurea-in-patients-with-polycythemia-vera-100523284","NCT06093672","Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera","Randomized, Open-label, Multicenter Phase 3 Study to Assess the Efficacy and Safety of GIVinostat Versus Hydroxyurea IN JAK2V617F-positive High-risk Polycythemia Vera Patients: the GIV-IN PV TRIAL","GIV-IN-PV","Core Treatment - Inclusion Criteria:\n\n* Patients must have been diagnosed with PV according to the 2016 WHO criteria before randomization\n* Patients must have JAK2V617F-positive disease\n* Patients with PV must meet the definition of HR for thrombosis (i.e., HR) within 3 years before screening as follows:\n\n  * Age ≥ 60 years, and\u002For\n  * Prior thrombosis.\n* Patients must be in need of treatment at screening, defined by the presence of at least one of the following:\n\n  * HCT ≥ 45% or HCT \\\u003C 45% with at least 1 phlebotomy performed in the 3 months before screening, or\n  * WBC count \\> 10 × 109\u002FL, or\n  * PLT count \\> 400 × 109\u002FL.\n* Patients must have normalized HCT (i.e., HCT \\\u003C 45%) at randomization\n\nExtended Treatment - Inclusion Criteria\n\n* Patients must have completed the Week 48 visit of the DSC\u002F08\u002F2357\u002F32 core treatment phase and:\n\n  1. if the patient received givinostat, a complete hematological response (CHR) at Week 48 shall be achieved\n  2. if the patient received HU, did not achieve a CHR (see above for the definition) at Week 48\n\n     Core Treatment phase - Exclusion Criteria\n* Patients pre-treated with HU with a documented history of resistance or intolerance to HU defined by the original ELN criteria\n* Patients with a QTcF value of \\> 450 msec for males and \\> 460 msec for females at the Screening visit (as the mean of 3 consecutive readings 5 minutes apart in the event a first ECG demonstrates a prolonged QTcF interval); congenital or acquired history of QTc prolongation or ventricular arrhythmias, at the Screening visit\n* Splanchnic thrombosis and\u002For thrombosis of the cerebral venous sinuses and\u002For splenectomy in the medical history\n* Patients with clinically significant cardiovascular disease\n* Patients with myocardial infarction, stroke or unstable angina within the 6 months prior to screening.\n* Patients with inadequate liver or renal function at screening\n* Uncontrolled hypertriglyceridemia at screening, i.e., triglycerides ˃ 1.5 × ULN\n* Previous treatment with a JAK2 or HDAC inhibitor or 32-phosphorus (radioactive isotope) therapy.\n* Patients being treated concurrently with any investigational agent or prior participation in an interventional clinical study within the 30 days prior to screening or within 5 half-lives of the investigational product, whichever is longer.\n* Pregnant or nursing women\n\nExtended treatment phase - Exclusion criteria\n\n* For patients randomized to givinostat in the core treatment phase - Patients with a QTcF value at Week 48 of \\> 500 msec\n* For patients randomized to HU in the core treatment phase:\n\n  * PLT count ≤ 150 × 109\u002FL at Week 48\n  * ANC \\\u003C 1.2 × 109\u002FL at Week 48\n  * Uncontrolled hypertriglyceridemia at Week 48\n  * Patients with a QTcF value at Week 48 of \\> 450 msec for males and \\> 460 msec for female",{"count":191,"type":22},220,[25],"The goal of this clinical trial is to compare the efficacy and safety of givinostat to hydroxyurea in Jak2V617F-positive high risk polycythemia vera patients.",[28],[28,196],"Givinostat",{"date":198,"type":33},"2026-03-25",{"date":200,"type":33},"2024-03-26",{"date":202,"type":22},"2026-07",{"name":204,"class":40},"Italfarmaco",90,{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":23,"phases":215,"briefSummary":216,"conditions":217,"keywords":221,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":234},"100454547","phase-3-avajak-apixabanrivaroxaban-versus-aspirin-for-primary-prevention-of-thrombo-embolic-complications-in-jak2v617f-positive-myeloproliferative-neoplasms-100454547","NCT05198960","AVAJAK: Apixaban\u002FRivaroxaban Versus Aspirin for Primary Prevention of Thrombo-embolic Complications in JAK2V617F-positive Myeloproliferative Neoplasms","AVAJAK","Inclusion Criteria:\n\n* Patients with diagnosis of PV or ET or PreMF according to WHO or BSCH criteria (bone marrow biopsy not compulsory).\n* Patients with JAK2V617F mutation (threshold allele burden \\> 1%).\n* Patients considered as \"high-risk\" patients:\n\n  1. based on age (\\> 60-year-old)\n  2. based on thrombotic history (compatible with antithrombotic randomization) but aged ≥ 18-year-old.\n* Length of time from MPN diagnostic to inclusion will not exceed 12 months.\n\nExclusion Criteria:\n\n* Contra-indication to aspirin or DOAC due to allergic situation or recent history of major bleeding.\n* Formal indication of treatment with aspirin or DOAC (thus precluding randomization).\n* Inability to give informed consent.\n* Patients under curatorship\u002Fguardianship\n* Concomitant use of a strong inhibitor or inducer of CYP3A4 (like ruxolitinib).\n* Chronic liver disease or chronic hepatitis.\n* Renal insufficiency with creatinine \\\u003C30 ml\u002Fmn on Cockcroft and Gault Formula\n* Patient considered at high-risk of bleeding: patients with current or recent major or clinical relevant non major bleeding gastrointestinal or cerebral bleedings\n* Planned pregnancy within 24 months\n* No appropriate contraception (estrogen contraception or no contraception) in women of childbearing age or breastfeeding woman\n* PS\\>2 or life expectancy \\\u003C12 months.",{"count":214,"type":22},1308,[25],"Philadelphia-negative myeloproliferative neoplasms (MPN) are frequent and chronic myeloid malignancies including Polycythemia Vera (PV), essential thrombocythemia (ET), Primary Myelofibrosis (PMF) and Prefibrotic myelofibrosis (PreMF). These MPNs are caused by the acquisition of mutations affecting activation\u002Fproliferation pathways in hematopoietic stem cells. The principal mutations are JAK2V617F, calreticulin (CALR exon 9) and MPL W515. ET or MFP\u002FPreMF patients who do not carry one of these three mutations are declared as triple-negative (3NEG) cases even if they are real MPN cases.\n\nThese diseases are at high risk of thrombo-embolic complications and with high morbidity\u002Fmortality. This risk varies from 4 to 30% depending on MPN subtype and mutational status.\n\nIn terms of therapy, all patients with MPNs should also take daily low-dose aspirin (LDA) as first antithrombotic drug, which is particularly efficient to reduce arterial but not venous events.\n\nDespite the association of a cytoreductive drug and LDA, thromboses still occur in 5-8% patients\u002Fyear.\n\nAll these situations have been explored in biological or clinical assays. All of them could increase the bleeding risk. We should look at different ways to reduce the thrombotic incidence: Direct Oral Anticoagulants (DOAC)? In the general population, in medical or surgical contexts, DOACs have demonstrated their efficiency to prevent or cure most of the venous or arterial thrombotic events.\n\nAt the present time, DOAC can be used in cancer populations according to International Society on Thrombosis and Haemostasis (ISTH) recommendations, except in patients with cancer at high bleeding risk (gastro-intestinal or genito-urinary cancers). Unfortunately, in trials evaluating DOAC in cancer patients, most patients have solid rather than hematologic cancers (generally less than 10% of the patients, mostly lymphoma or myeloma).\n\nIn cancer patients, DOAC are also highly efficient to reduce the incidence of thrombosis (-30 to 60%), but patients are exposed to a higher hemorrhagic risk, especially in digestive cancer patients.\n\nIn the cancer population, pathophysiology of both thrombotic and hemorrhagic events may be quite different between solid cancers and MPN. If MPN patients are also considered to be cancer patients in many countries, the pathophysiology of thrombosis is quite specific (hyperviscosity, platelet abnormalities, clonality, specific cytokines…) and they are exposed to a lower risk of digestive hemorrhages. It is thus difficult to extend findings from the \"general cancer population\" to MPN patients.\n\nUnfortunately, only scarce, retrospective data regarding the use of DOAC in MPNs are available data.\n\nWe were the first to publish a \"real-life\" study about the use, the impact, and the risks in this population. In this local retrospective study, 25 patients with MPN were treated with DOAC for a median time of 2.1 years. We observed only one thrombosis (4%) and three major hemorrhages (12%, after trauma or unprepared surgery). Furthermore, we have compared the benefit\u002Frisk balance compared to patients treated with LDA without difference.\n\nWith the increasing evidences of efficacy and tolerance of DOAC in large cohorts of patients including cancer patients, with their proven efficacy on prevention of both arterial and venous thrombotic events and because of the absence of prospective trial using these drugs in MPN patients, we propose to study their potential benefit as primary thrombotic prevention in MPN.",[28,170,218,219,220],"Prefibrotic\u002FEarly Primary Myelofibrosis","JAK2 V617F","High-risk Patients",[222,223,224],"Venous ThromboEmbolism","Arterial Thrombosis","Hemorrhage","2026-03-18",{"date":227,"type":33},"2026-03-20",{"date":229,"type":33},"2022-07-13",{"date":231,"type":22},"2027-07-13",{"name":233,"class":89},"University Hospital, Brest",42,{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":23,"phases":243,"briefSummary":244,"conditions":245,"keywords":251,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":130},"100384169","phase-2-decitabine-with-ruxolitinib-fedratinib-or-pacritinib-for-the-treatment-of-acceleratedblast-phase-myeloproliferative-neoplasms-100384169","NCT04282187","Decitabine With Ruxolitinib, Fedratinib or Pacritinib for the Treatment of Accelerated\u002FBlast Phase Myeloproliferative Neoplasms","A Phase 2 Trial Investigating Decitabine in Combination With a JAK-Inhibitor as a Bridge to Allogeneic Hematopoietic Stem Cell Transplant in Patients With Accelerated\u002FBlast Phase Myeloproliferative Neoplasms","Inclusion Criteria:\n\n* Age \\>= 18 years\n* History of MPN as defined by the 2016 World Health Organization criteria, with now pathologically confirmed \\>= 5% blasts in the bone marrow or peripheral blood. Prior MPNs could include polycythemia vera, essential thrombocythemia, primary myelofibrosis, secondary myelofibrosis, MPN unclassifiable, MDS\u002FMPN overlap\n* Outside diagnostic material is acceptable as long as peripheral blood and\u002For bone marrow slides are reviewed at the study institution by pathology. Flow cytometric analysis of peripheral blood and\u002For bone marrow should be performed according to institutional practice guidelines\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or Karnofsky \\>= 60%\n* Serum creatinine clearance \\>= 50 ml\u002Fmin calculated by the Cockcroft-Gault Equation (assessed within 14 days of study day 1)\n* Total bilirubin =\\\u003C 3 unless due to Gilbert's disease or hemolysis (total bilirubin \\> 3 is allowable if thought due to Gilbert's disease, hemolysis, or MPN disease) (assessed within 14 days of study day 1)\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) \\\u003C 3 x upper limit of normal (ULN) unless thought to be due to MPN disease process (AST\u002FALT \\> 3 is allowable if thought due to MPN disease) (assessed within 14 days of study day 1)\n* For patient receiving fedratinib, thiamine level should be above the laboratory lower limit of normal (\\>= 70 nmol\u002FL in the University of Washington \\[UW\\]\u002FSeattle Cancer Care Alliance \\[SCCA\\] lab). If it is low, it may be repleted but should be rechecked and demonstrated to normalize prior to initiation of therapy\n* Patient is considered a potential transplant candidate. The attending\u002Ftreating physician will determine transplant candidacy at the time of consent\n* The use of hydroxyurea prior to study registration is allowed. Patients with symptoms\u002Fsigns of hyperleukocytosis, white blood count (WBC) \\> 100,000\u002FuL, or with concern for other complications of high tumor burden or leukostasis (e.g. hypoxia, disseminated intravascular coagulation) can be treated with leukapheresis or may receive up to 2 doses of cytarabine (up to 500 mg\u002Fm\\^2 \u002Fdose) anytime prior to enrollment\n* Capable of providing valid informed consent\n\nExclusion Criteria:\n\n* Previous treatment with chemotherapy (e.g. hypomethylating agents or cytarabine-based regimens) for MPN with \\>= 5% blasts in the blood or marrow. Prior temporary measures to control blood counts is allowed. Prior treatment with hydroxyurea, interferons or JAK inhibitor therapy is allowed\n* Active systemic fungal, bacterial, viral, or other infection, unless disease is under treatment with anti-microbials and\u002For controlled or stable (e.g. if specific, effective therapy is not available\u002Ffeasible or desired \\[e.g. chronic viral hepatitis, human immunodeficiency virus (HIV)\\])\n* Known hypersensitivity to any study drug\n* Females who are pregnant or breastfeeding\n* Treatment with any other anti-MDS\u002Fleukemia investigational agent within 2 weeks of start of study drugs\n* For patients planning to receive fedratinib: concurrent use of strong and moderate CYP3A4 inducers or dual CYP3A4 and CYP2C19 inhibitors that cannot be discontinued\n* For patients planned to receive ruxolitinib AND platelets \\\u003C 50,000\u002Fmm\\^2: concurrent use of a strong CYP3A4 inhibitor that cannot be discontinued\n* For patients planned to receive pacritinib, corrected QT interval (QTc) \\> 480 msec (changing of medications\u002Fsupplementing electrolytes is allowed to determine if this helps QTc reduce to \\\u003C 480 msec)\n* For patients planned to receive pacritinib, concurrent use of medications that are CYP1A2, CYP3A4, P-gp, BCRP, OCT1 substrates that cannot be discontinued",{"count":7,"type":22},[52],"This phase II trial studies how well decitabine with ruxolitinib, fedratinib, or pacritinib works before hematopoietic stem cell transplant in treating patients with accelerated\u002Fblast phase myeloproliferative neoplasms (tumors). Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ruxolitinib, fedratinib, and pacritinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy before a donor hematopoietic stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells. Decitabine, with ruxolitinib, fedratinib, or pacritinib may work better than multi-agent chemotherapy or no pre-transplant therapy, in treating patients with accelerated\u002Fblast phase myeloproliferative neoplasms.",[246,170,171,247,248,249,28,144,250],"Acute Myeloid Leukemia","Myelodysplastic\u002FMyeloproliferative Neoplasm","Myeloproliferative Neoplasm","Myeloproliferative Neoplasm, Not Otherwise Specified","Secondary Myelofibrosis",[252,253],"Myeloid and Monocytic Leukemia","Other Hematopoietic","2026-03-11",{"date":256,"type":33},"2026-03-16",{"date":258,"type":33},"2020-03-24",{"date":260,"type":22},"2026-11-11",{"name":262,"class":89},"University of Washington",{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":23,"phases":271,"briefSummary":273,"conditions":274,"keywords":276,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":181},"100448738","phase-1-an-optimal-dose-finding-study-of-n-acetylcysteine-in-patients-with-myeloproliferative-neoplasms-100448738","NCT05123365","An Optimal Dose Finding Study of N-Acetylcysteine in Patients With Myeloproliferative Neoplasms","Inclusion Criteria:\n\n* ≥18 years of age\n* Have a diagnosis of essential thrombocythemia (ET), polycythemia vera (PV), or myelofibrosis (MF) according to the 2016 WHO criteria\n* Has not taken interferon-alpha or a JAK inhibitor (such as ruxolitinib or fedratinib) for treatment of MPN in the past 28 days before enrollment.\n* May continue on current MPN treatment, including aspirin, hydroxyurea, or anagrelide. Therapeutic phlebotomies should continue per the patient's usual regimen.\n* Has not taken N-Acetylcysteine (N-AC) or preparations containing N-AC in the past 28 days before enrollment.\n* Baseline MPN-TSS score of ≥ 10 at the time of enrollment.\n* Peripheral blast count \\\u003C10% during Screening.\n* Free of other active or metastatic malignancies other than localized skin cancer.\n* Amenable to blood draws and symptom assessments.\n* Agree to the use of contraceptives. Female subjects of childbearing potential and their male partners, or male subjects who have female partners of childbearing potential, should both use an effective contraception method during the study and continue to use contraception for 60 days after the last dose of study drug.\n\nExclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) questionnaire score of ≥3\n* Currently pregnant or planning on being pregnant within the study period.\n* Currently breastfeeding.\n* Known uncontrolled active viral or bacterial infection.\n* Significant impairment of major organ function defined as\n\n  1. Serum creatinine clearance less than 50 ml\u002Fmin (calculated with Cockroft-Gault formula).\n  2. Bilirubin more than 1.5 mg\u002Fdl except for Gilbert's disease. ALT or AST more than 2X upper normal limit or has radiologic evidence of liver cirrhosis.\n  3. Platelets \\\u003C 100 × 10\\^9\u002FL\n  4. Hgb \\\u003C 10 g\u002FdL\n  5. ANC \\\u003C 0.75 × 10\\^9\u002FL\n* Known history of allergic reaction to N-AC.",{"count":270,"type":22},27,[272,52],"PHASE1","This is a phase I\u002FII study evaluating the optimal dose of N-acetylcysteine (N-AC) in patients with myeloproliferative neoplasms (MPN).",[248,275,170,28,145],"MPN",[275,248,277,28,145],"Essential Thrombocytemia","2026-03-06",{"date":280,"type":33},"2026-03-10",{"date":282,"type":33},"2022-01-03",{"date":284,"type":22},"2026-11-15",{"name":286,"class":89},"University of California, Irvine",{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":296,"phases":4,"briefSummary":297,"conditions":298,"keywords":347,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":181},"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":295,"type":22},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.",[28,299,300,301,302,303,145,304,106,305,306,307,308,309,310,311,312,313,250,314,315,316,317,318,319,320,321,322,323,324,325,326,327,328,329,330,331,332,333,275,334,335,336,249,337,338,339,340,341,143,342,343,344,345,346],"ET (Essential Thrombocythemia)","Polycythemia Vera (PV)","Essential Thrombocythemia (ET)","Primary Myelofibrosis (MF)","Primary Myelofibrosis (PMF)","Myelofibrosis (MF)","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 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 (Myeloproliferative Neoplasms)","MPN-associated Myelofibrosis","Myeloproliferative Neoplasm, Unclassifiable","Accelerated Phase MPN","Accelerated Phase Myeloproliferative Neoplasm","Blast Phase MPN","Blast Phase Myeloproliferative Neoplasm","Thrombocythemia Myelofibrosis (PET-MF)","Thrombocythemia, Hemorrhagic","Agnogenic Myeloid Metaplasia","Chronic Idiopathic Myelofibrosis","Idiopathic Myelofibrosis","MDS\u002FMPN Crossover Syndromes",[333,28,170,250,348,327,336,349,350,351,352,353,354,355,356,357,358,359,360,361,362,363,116,364,365,366,367,368,369,370,371,372,373,374,375,376],"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","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":379,"type":33},"2026-01-23",{"date":381,"type":33},"2025-09-26",{"date":383,"type":22},"2035-09-08",{"name":385,"class":89},"MPN Research Foundation",{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":392,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":394,"targetDuration":4,"studyType":296,"phases":4,"briefSummary":396,"conditions":397,"keywords":398,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":130},"100573188","ropeginterferon-alfa-2b-in-patients-with-polycythemia-vera-pv-without-symptomatic-splenomegaly-100573188","NCT06743035","Ropeginterferon Alfa-2b in Patients With Polycythemia Vera (PV) Without Symptomatic Splenomegaly","Ropeginterferon Alfa-2b in Patients With Polycythemia Vera (PV) Without Symptomatic Splenomegaly: A Prospective, Longitudinal, Multicenter, Observational Study in Germany","ROPE","Inclusion Criteria:\n\n* Age ≥18 years\n* Confirmed diagnosis of PV without symptomatic splenomegaly\n* Indication and decision for treatment with ropeginterferon alfa-2b in accordance with current SmPC\n* No prior treatment with ropeginterferon alfa-2b (Patients are allowed to be enrolled up to 6 weeks after their first dose of ropeginterferon alfa-2b but must still be on treatment at the time of enrollment.)\n* Dated signature of informed consent form\n* Participation in Patient-Reported Outcome (PRO) assessment in German language and completion of questionnaire at time of study enrollment\n* Other criteria according to current Summary of Product Characteristics\n\nExclusion Criteria:\n\n* Participation in an interventional clinical trial (except follow-up)\n* Other contraindications according to current Summary of Product Characteristics",{"count":395,"type":22},200,"The primary objective of this non interventional study is to evaluate symptom burden in adult patients with PV without symptomatic splenomegaly during treatment with ropeginterferon alfa-2b in a real-world setting. Further patient-relevant endpoints include effectiveness including complete hematologic response (CHR), event-free survival (EFS), safety and tolerability, treatment reality including dosing details as well as factors affecting treatment decision making.",[28],[399,400,401,402],"Ropeginterferon alfa-2b","polycythemia vera","symptom burden","myeloproliferative neoplasm","2026-01-08",{"date":405,"type":33},"2026-01-09",{"date":407,"type":33},"2024-12-03",{"date":409,"type":22},"2029-07",{"name":411,"class":40},"iOMEDICO AG",{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":23,"phases":421,"briefSummary":422,"conditions":423,"keywords":424,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":434},"100411950","phase-2-ruxolitinib-in-thrombocythemia-and-polycythemia-vera-100411950","NCT04644211","Ruxolitinib in Thrombocythemia and Polycythemia Vera","A Phase 2 Study Of Ruxolitinib In Low-Risk Essential Thrombocythemia And Polycythemia Vera With Significant Symptom Burden","Inclusion Criteria:\n\n* Patients who have been diagnosed with essential thrombocythemia or polycythemia vera by World Health Organization 2016 diagnostic criteria.\n* Patients with essential thrombocythemia must be very low (no history of thrombosis, age \\\u003C60, and no JAK2 mutation), low (no history of thrombosis, age \\\u003C60, presence of JAK2 mutation), or intermediate risk (no history of thrombosis, age \\>60, no JAK2 mutation) by IPSET criteria. Patients with polycythemia vera must be low risk (no history of thrombosis and age \\\u003C60) by NCCN guidelines.\n* Patients with an MPN-SAF TSS (MPN-10) score \\>10 AND at least one individual feature \\>5 documented on a separate visit within 3 months prior to study registration, as documented in the clinical record or obtained by clinician. If not previously documented in the electronic medical record, participants must be blinded to purpose of MPN SAF TSS scoring for eligibility determination. Average daily MPN-SAF TSS (MPN-10) score must remain \\>10 with any individual feature \\>5 for the week-long baseline assessment prior to ruxolitinib initiation.\n* Patients who have previously received or are receiving cytoreductive therapy (i.e. hydroxyurea, anagrelide, interferon) are eligible for the study if therapy was used for the indication of symptom control, or if therapy was used for pre-operative control of blood counts. If a subject is still receiving cytoreductive therapy at the time of screening and enrollment, there will be a wash-out period from prior cytoreductive therapy at least 7 days prior to ruxolitinib initiation.\n* Age ≥18 years.\n* ECOG performance status ≤2 (Karnofsky ≥60%)\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes ≥3,000\u002FmcL\n  * absolute neutrophil count ≥1,500\u002FmcL\n  * platelets ≥100,000\u002FmcL\n  * total bilirubin ≤ institutional upper limit of normal (ULN)\n  * AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN\n  * creatinine ≤ institutional ULN OR glomerular filtration rate (GFR) ≥60 mL\u002Fmin\u002F1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL\u002Fmin\u002F1.73 m2\n* Participants with a prior or concurrent malignancy not receiving treatment for concurrent cancer diagnosis and\u002For prior concurrent malignancy within 5 years except for basal cell carcinoma or squamous cell carcinoma of the skin.\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* For participants with evidence of chronic human immunodeficiency virus (HIV) infection, they must be negative for HBV DNA, HCV RNA, or hepatitis B surface antigen (BsAg) on suppressive therapy, if indicated.\n* Participants must be previously vaccinated with the Herpes Zoster (Shingles) vaccine or must be willing to start prophylactic Acyclovir 400 mg twice daily (BID) or suitable alternative for duration of treatment with ruxolitinib.\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Essential thrombocythemia patients who are high risk by IPSET-R criteria (age \\> 60 with JAK2 V617F mutation and\u002For history of thrombosis).1 Polycythemia vera patients who are high risk by NCCN guidelines (age \\> 60 and\u002For history of thrombosis).\n* Patients with \\>5% blasts on baseline marrow exam or at any other time in peripheral blood\n* Participants who are receiving any other investigational agents.\n* Participants with a history of splenectomy. Participants may still be eligible after discussion with and approval by the Overall PI, however.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ruxolitinib or excipients of ruxolitinib.\n* Participants requiring any medications or substances that are strong inhibitors or 3A4 isozyme are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment\u002Finformed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.\n* Participants with uncontrolled intercurrent illness.\n* Participants with inadequate liver or renal function at screening as evidenced by lab values not meeting criteria\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because ruxolitinib is a Class C agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ruxolitinib, breastfeeding should be discontinued if the mother is treated with ruxolitinib.\n* The effects of ruxolitinib on the developing human fetus are unknown. Pregnant women and subjects of childbearing potential who are unwilling to take appropriate precautions to avoid becoming pregnant or fathering a child are ineligible. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of ruxolitinib administration.",{"count":420,"type":22},60,[52],"This research is being done to see if the drug ruxolitinib is effective in reducing the symptoms caused by low-risk essential thrombocythemia (ET) and polycythemia vera (PV).\n\n\\- This research study involves the study drug Ruxolitinib.",[170,28],[170,28,425],"Sympton Burden","2026-01-07",{"date":403,"type":33},{"date":429,"type":33},"2022-03-21",{"date":431,"type":22},"2034-07",{"name":433,"class":89},"Massachusetts General Hospital",4,{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":443,"enrollmentInfo":444,"targetDuration":4,"studyType":296,"phases":4,"briefSummary":446,"conditions":447,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":7},"100608608","a-eln-multicenter-study-on-phenotypic-evolution-and-clinical-outcomes-100608608","NCT07203768","A ELN-Multicenter Study on Phenotypic Evolution and Clinical Outcomes","Unmasking Polycythemia Vera in Long-Standing Essential Thrombocythemia: A ELN-Multicenter Study on Phenotypic Evolution and Clinical Outcomes","ET2PV","Inclusion Criteria:\n\n\\- ET patients (diagnosed according to \"International consensus classification of myeloid neoplasms and acute leukemias - 2022\" criteria) who are JAK2V617F positive and have progressed to PV (diagnosed according to \"International consensus classification of myeloid neoplasms and acute leukemias - 2022\" criteria) by 31\u002F12\u002F2020. The date of PV diagnosis will be defined as the index date and this group of patients will be defined as ET-to-PV cases.\n\nExclusion Criteria:\n\n* None.","100 Years",{"count":445,"type":22},678,"International multicenter retrospective observational study consisting of two parts: a nested case-control study (part A) and a comparative retrospective cohort study (part B).",[28,448],"Thrombocythemia","2025-12-19",{"date":451,"type":33},"2025-12-26",{"date":453,"type":33},"2025-12-01",{"date":455,"type":22},"2026-07-31",{"name":457,"class":89},"FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS",{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":462,"acronym":463,"eligibilityCriteria":464,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":443,"enrollmentInfo":465,"targetDuration":4,"studyType":296,"phases":4,"briefSummary":467,"conditions":468,"keywords":469,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":470,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":476},"100573950","low-pv-continuation-100573950","NCT06752941","LOW-PV Continuation","CONT-LOW-PV","Inclusion Criteria:\n\n* Patients enrolled in the LOW-PV RCT study who continued to receive Ropeginterferon alfa-2b until the conclusion of the study on March 31, 2023. These patients will be included regardless of the treatment they are undergoing at the time of enrollment in the current study.\n* Patients who have signed the written informed consent for study participation.\n\nExclusion Criteria:\n\n* None",{"count":466,"type":22},36,"This multicenter longitudinal observational study focuses on Italian patients with Polycythemia Vera (PV) who were enrolled in the Low-PV RCT and continued receiving Ropeginterferon alfa-2b until the study's conclusion on March 31, 2023. It includes patients who were responders to Ropeginterferon alfa-2b after two years in the phase II randomized trial \"LOW-PV.\" Data will be collected retrospectively every 6 months from March 31, 2023 to November 30, 2024 and prospectively from December 1, 2024 to March 31, 2026.",[28],[399],{"date":451,"type":33},{"date":472,"type":33},"2024-11-30",{"date":474,"type":22},"2026-03-31",{"name":457,"class":89},13,{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":483,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":23,"phases":487,"briefSummary":488,"conditions":489,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":500},"100543882","functional-and-phenotypic-characterization-of-monocytes-in-myeloproliferative-syndromes-100543882","NCT06361641","Functional and Phenotypic Characterization of Monocytes in Myeloproliferative Syndromes","Functional and Phenotypic Characterization of Monocytes in Myeloproliferative Syndromes-PHEMOP","PHEMOP","Inclusion Criteria:\n\n* Diagnosis of PV, ET, pre-myelofibrosis or primary myelofibrosis according to WHO 2022 criteria (including BOM for ET, premyelofibrosis and primary myelofibrosis)\n* Patient who has not received treatment specific to hemopathy at the time of sampling\n* Obtaining the signature of consent to participate in the study\n* Patient having consented to be included in the \"Malignant Hemopathy\" collection of Angers University Hospital and in FIMBANK database\n\nExclusion Criteria:\n\n* Person not affiliated to a social security scheme or beneficiary of such a scheme\n* Patient with another hemopathy or another active cancer at the time of diagnosis\n* Minor patient at diagnosis (\\\u003C 18 years old)\n* Patient not capable or without agreement from the guardian or legal representative",{"count":486,"type":22},70,[101],"Prospective study for functional and phenotypic characterization of monocytes in philadelphia-negative myeloproliferative neoplasms",[248,28,170,144],"2025-12-02",{"date":492,"type":33},"2025-12-08",{"date":494,"type":33},"2024-05-29",{"date":496,"type":22},"2028-10-19",{"name":498,"class":499},"University Hospital, Angers","OTHER_GOV",3,{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":23,"phases":510,"briefSummary":511,"conditions":512,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":532,"locationsCount":130},"100441709","phase-2-two-step-haplo-with-radiation-conditioning-100441709","NCT05031897","Two Step Haplo With Radiation Conditioning","A 2 Step Approach to Haploidentical Transplant Using Radiation-Based Reduced Intensity Conditioning","Inclusion Criteria:\n\n* Radiation-based cohort diagnoses:\n\n  * Acute myeloid leukemia\n  * Acute lymphoid leukemia in remission\n  * Myelodysplasia (MDS)\n  * Chronic lymphocytic leukemia (CLL) with no or minimal lymph node involvement\n  * Multiple myeloma\n  * Chronic myeloid leukemia\n  * Myelofibrosis\n  * Myeloid malignancy not otherwise specified\n  * Chronic myelomonocytic leukemia\n  * Essential thrombocytopenia or polycythemia vera\n  * T cell leukemia\n  * T cell lymphoma without significant lymph node disease burden\n  * Any hematological malignancy or dyscrasia not cited above in which HSCT is potentially curable\n  * Any patient who has a hematological disease that would normally be treated on a myeloablative study, but is prevented from doing so by factors in their past medical history. Examples are patients with previous treatment with radiation therapy precluding total-body irradiation (TBI), or a past history of myeloablative therapy, precluding a 2nd myeloablative regimen.\n  * Patients must have a donor who is one-haplotype mismatched (number of mismatches in either direction not considered)\n* Chemotherapy-based cohort diagnoses:\n\n  * Hodgkin or non-Hodgkin lymphoma\n  * Small lymphocytic lymphoma\u002FCLL\n  * Any other diagnosis in which chemotherapy is thought to be superior to radiotherapy for treatment of the disease\n  * Hematological malignancy in patients who cannot receive \\> 2 Gy radiation\n  * Aplastic anemia and other non-malignant hematologic dyscrasias\n  * Patients must have a donor who is one-haplotype mismatched (number of mismatches in either direction not considered)\n* Human leukocyte antigen (HLA) identical cohort diagnoses:\n\n  \\* Patients in this group will be treated in parallel to the radiation-based cohort or the chemotherapy-based group based on what category their diagnosis falls into. However, these patients will have HLA identical related donors (one-antigen cross-over event included).\n* Left ventricular ejection fraction of \\>= 50%\n* Diffusion lung capacity of oxygen \\>= 50% and forced expiratory volume at 1 second \\>= 50% of predicted corrected for hemoglobin\n* Serum bilirubin =\\\u003C 1.8\n* Aspartate aminotransferase or alanine aminotransferase =\\\u003C 2.5 x upper limit of normal\n* Creatinine clearance of \\>= 60 mL\u002Fmin\n* Patients must have adequate Karnofsky performance status (KPS) and Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) scores:\n\n  * Patients \\\u003C age 60 years must have a KPS of \\>= 60% and an HCT-CI score of 5 or less\n  * Patients aged 60 to 65 years must have a KPS of \\>= 60% and an HCT-CI score of 4 or less\n  * Patients aged 66 to 69 years must have a KPS of 90% and an HCT-CI score of 3 or less\n  * Patients aged 70 years or more must have a KPS of 90% and an HCT-CI score of 2 or less\n  * (Patients with greater than the allowable HCT-CI points for age can be enrolled for trial with approval of the principal investigator (PI) and at least 1 co-investigator (CI) not on the primary care team of the patient). This is an adjustment to account for healthy patients who meet the spirit of this protocol but have histories that result in higher than guideline HCT-CI points. An example is a patient with a solid tumor malignancy in their remote history (adds 3 points to HCT-CI total) where the treatment for the malignancy occurred years to decades before and there has been complete recovery of toxicities\n* Patients must be willing to use contraception if they have childbearing potential\n* Patient or patient's guardian is able to give informed consent\n* Patients should have a life expectancy of \\>= 6 months for reasons other than their underlying hematologic\u002Foncologic disorder\n* Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol\n* Patients should not be:\n\n  * Human immunodeficiency virus positive\n  * Have active involvement of the central nervous system with malignancy. This can be documented by a normal neurological exam, magnetic resonance imaging (MRI) of the head, and\u002For a negative cerebral spinal fluid analysis\n* Pregnant or breastfeeding",{"count":509,"type":22},63,[52],"This phase II clinical trial evaluates whether a modified modality of conditioning reduces treatment-related mortality (TRM) in patients who undergo a hematopoietic stem cell transplant (HSCT) for a hematological malignancy. HSCT is a curative therapy for many hematopoietic malignancies, however this regimen results in higher rates of TRM than other forms of treatment. In recent years, less intense conditioning regimens with radiation and chemotherapy prior to HSCT have been developed. Radiation therapy uses high energy sources to kill cancer cells and shrink tumors while chemotherapy drugs like fludarabine and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study evaluates whether a two-step approach with lower-intensity regimens of these treatments prior to HSCT reduces the rate of TRM.",[513,246,514,515,516,517,518,170,519,520,521,171,145,522,523,28,524],"Acute Lymphoblastic Leukemia","Adult T-Cell Leukemia\u002FLymphoma","Aplastic Anemia","Chronic Lymphocytic Leukemia","Chronic Myeloid Leukemia, BCR-ABL1 Positive","Chronic Myelomonocytic Leukemia","Hematopoietic and Lymphatic System Neoplasm","Hodgkin Lymphoma","Multiple Myeloma","Myeloid Neoplasm","Non-Hodgkin Lymphoma","Small Lymphocytic Lymphoma","2025-10-28",{"date":527,"type":33},"2025-10-30",{"date":529,"type":33},"2021-10-25",{"date":531,"type":22},"2032-04",{"name":533,"class":89},"Thomas Jefferson University",{"id":535,"slug":536,"hasResults":12,"nctId":537,"briefTitle":538,"officialTitle":539,"acronym":4,"eligibilityCriteria":540,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":541,"targetDuration":4,"studyType":23,"phases":543,"briefSummary":544,"conditions":545,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":554,"locationsCount":556},"100545172","phase-1-a-study-of-glb-001-in-patients-with-myeloid-malignancies-100545172","NCT06378437","A Study of GLB-001 in Patients With Myeloid Malignancies","A Phase 1, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of GLB-001 in Patients With Myeloid Malignancies","Inclusion Criteria:\n\n* Study participants must understand and voluntarily sign a written informed consent form (ICF) prior to any study-related assessments\u002Fprocedures being performed.\n* Study participants is ≥18 years of age at the time of signing the ICF.\n* Study participants with confirmed diagnosis of relapsed or refractory or intolerant myeloid malignancies including PV, ET, primary myelofibrosis (PMF), MDS and AML according to 2022 World Health Organization (WHO) criteria classification, and post-polycythemia vera myelofibrosis (post-PV MF) and post-essential thrombocythemia myelofibrosis (post-ET MF) according to the 2013 IWG-MRT criteria.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.\n* Life expectancy \\> 3 months.\n* Good performance of major organs, including hematology, liver and kidney function, and coagulation. etc.\n* Study participants are willing and able to adhere to the study visit schedule and other protocol requirements.\n\nExclusion Criteria:\n\n* Study participants with acute promyelocytic leukemia (APL).\n* Receipt of following anticancer medications\u002Ftherapies prior to the first dose of GLB-001: (1) study participants with PV or ET who received treatment with hydroxyurea within 2 days prior to the first dose, or any other treatment for PV or ET within 7 days prior to first dose of GLB-001, (2) study participants with MF who received any type of treatment for MF within 14 days prior to the first dose, such as chemotherapy, immunotherapy, radiotherapy and erythropoietin, androgens, thrombopoietin or granulocyte colony-stimulating factor, (3) study participants with LR-MDS who received any type of treatment for MDS within 14 days prior to the first dose, (4) study participants with HR-MDS or AML who received chimeric antigen receptor T cell therapy (CAR-T) or other biologic therapy within 28 days prior to the first dose of GLB-001, or received any other anticancer therapies within 14 days prior to the first dose of GLB-001.\n* Receipt of any other investigational drug study within 28 days or 5 half-lives of that study drug before the first dose of GLB-001.\n* Study participants with unresolved clinically significant non-hematologic toxicities that were ≥ Grade 1 or failed to recover to baseline levels following prior anticancer therapies (with the exception of alopecia or skin hyperpigmentation).\n* Study participants who are scheduled to receive other anticancer therapies or other investigational drugs during the study period.\n* Study participants with active acute or chronic graft versus host disease (GVHD) requiring systemic immunosuppressive therapy.\n* Receipt of autologous stem cell transplantation (ASCT) within the last 3 months prior to the first dose of GLB-001, or allogeneic hematopoietic stem cell transplantation (allo-HSCT) within the last 6 months prior to the first dose of GLB-001.\n* Study participants with known active involvement in central nervous system (CNS).\n* Study participants with peripheral neuropathy ≥ Grade 2 (Graded according to CTCAE version 5.0).\n* Study participants have a history of known malignancy other than the inclusion diagnosis for the past 5 years, with the exception of curatively resected cancer in situ, including cervical carcinoma in situ, basal cell carcinoma of the skin, or prostate cancer in situ, etc.\n* QT interval interval \\> 450 milliseconds (ms) using electrocardiographic (ECG) at screening.\n* Study participants have impaired cardiac function or clinically significant cardiac disease at current or within last 6 months.\n* Study participants with known active infection of hepatitis B virus (HBV) or hepatitis C virus C (HCV).\n* Study participants with known human immunodeficiency virus (HIV) infection.\n* Study participants with known life-threatening or clinical significant uncontrolled active systemic infections unrelated to malignant hematologic diseases.\n* Study participants with a state condition that may alter affects the absorption, distribution, metabolism and excretion of GLB-001 after judgment of the investigator.\n* Medications or supplements that are known to be strong and moderate inhibitors or inducers of cytochrome P-450 isozyme 3A (CYP3A) and\u002For P-glycoprotein (P-gp), or strong inhibitors or inducers of CYP450 isozyme 2C8 (CYP2C8) within 7 days or 5 half-lives prior to the first dose of GLB-001, whichever is shorter prior to the first dose of GLB-001.\n* Study participants who have undergone major surgery within 28 days prior to the first dose of the GLB-001, or unability to recover from effects of surgery.\n* Pregnant or lactating women.\n* Study participants who have cognitive impairment due to any psychiatric or neurological condition, including epilepsy and dementia, may limit their understanding, performance, and study compliance with the ICF.\n* Study participants, in the opinion of the Investigator, who are unsuitable to participate in the study.",{"count":542,"type":22},108,[272],"Study GLB-001-02 is a phase 1, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of GLB-001 in study participants with relapsed or refractory or intolerant myeloid malignancies including polycythemia vera (PV), essential thrombocythemia (ET), myelofibrosis (MF), lower-risk myelodysplastic syndrome (LR-MDS), higher-risk myelodysplastic syndromes (HR-MDS), and acute myeloid leukemia (AML). This study consists of 3 parts, dose escalation (Phase 1a), dose exploration (Phase 1b) and dose expansion (Phase 1c). Dose escalation (Phase 1a) and dose exploration (Phase 1b) will evaluate the safety, tolerability, PK, PD and preliminary efficacy of GLB-001, administered orally, in study participants with PV\u002FET, or study participants with MF\u002FLR-MDS\u002FHR-MDS\u002FAML, respectively. Dose expansion (Phase 1c) will be followed to determine the relationships among dose, exposure, toxicity, tolerability and clinical activity, to identify minimally active dose, and to select the recommended dose(s) for phase 2 study. Approximately 108 study participants may be enrolled in the study.",[28,170,145,546,246,547],"Myelodysplastic Syndromes","Myeloid Malignancy","2025-08-17",{"date":550,"type":33},"2025-08-19",{"date":552,"type":33},"2024-05-24",{"date":127,"type":22},{"name":555,"class":40},"Hangzhou GluBio Pharmaceutical Co., Ltd.",14,{"id":558,"slug":559,"hasResults":12,"nctId":560,"briefTitle":561,"officialTitle":562,"acronym":563,"eligibilityCriteria":564,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":565,"enrollmentInfo":566,"targetDuration":4,"studyType":23,"phases":567,"briefSummary":569,"conditions":570,"keywords":571,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":4},"100538433","phase-4-efficacy-and-safety-of-ropeginterferon-alfa-2b-p1101-for-patients-with-polycythemia-vera-100538433","NCT06290765","Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera","Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera - A Randomized Open Label Global Multicenter Study (PARADIGM-PV)","PV","Inclusion Criteria:\n\n1. Age ≥18 years at the time of informed consent (or other age required by local regulations);\n2. PV according to the World Health Organization (WHO) 2016 or 2022 Criteria;\n3. At least 3 phlebotomies within 24 weeks or at least 5 phlebotomies within 52 weeks prior to screening due to inadequate control of Hct value;\n4. Have the following hematological values immediately prior to randomization at baseline:\n\n   1. Hematocrit \\\u003C45%, and\n   2. WBC ≥4× 109\u002FL, and\n   3. Platelets ≥100 × 109\u002FL;\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.\n6. Patients receiving cytoreductive therapy must be on a stable dose or minimal dose adjustments for at least 24 weeks before screening and with no planned dose change;\n7. Patients who are not receiving cytoreductive therapy must have been discontinued from any prior cytoreductive therapy for at least 24 weeks before screening and have recovered from any adverse events;\n8. Females of childbearing potential, as well as all women \\\u003C 2 years after the onset of menopause, must agree to use an acceptable form of birth control until 60 days following the last dose of the study drug;\n9. Written informed consent obtained from the patient or the patient's legal representative, and ability for the patient to comply with the study requirements.\n\nExclusion Criteria:\n\n1. Patients requiring phlebotomy at Hct levels ˂45% according to Investigator judgement;\n2. Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) or PV-related bleeding within 2 months prior to randomization;\n3. Post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) (Tefferi et al 2013, Barosi et al 2008);\n4. Contraindication to pegylated interferon or its excipients;\n5. known resistance or intolerance to interferon based therapies, as judged by Investigator;\n6. Documented autoimmune disease (e.g., thyroid dysfunction, idiopathic thrombocytopenic purpura (ITP), scleroderma, psoriasis, or any arthritis of autoimmune origin). Patients with well-managed thyroid disease by oral hormonal replacement therapy could be enrolled;\n7. Pulmonary infiltrates, pneumonia, and pneumonitis at screening that, in the Investigator's opinion, would jeopardize the safety or compliance with the protocol;\n8. Infections with systemic manifestations, e.g., bacterial, fungal, or human immunodeficiency virus (HIV), except inactive carriers of hepatitis B (HBV) and\u002For hepatitis C (HCV) at screening; inactive HBV carrier is defined as the presence of HBsAg and anti-Hepatitis B e-antigen (anti-HBe) antibody, HBV DNA ˂2000 IU\u002Fml, and normal ALT (Invernizz et al 2016); inactive HCV carrier is defined as the presence of HCV RNA but has normal ALT or with no clinically significant symptom as judged by investigator;\n9. Any investigational drug less than 6 weeks prior to randomization or not recovered from the effects of prior administration of any investigational agent;\n10. History or presence of depression requiring treatment with antidepressant;\n11. Previous suicide attempts or at any risk of suicide at screening, in the judgement of the Investigator;\n12. Any significant morbidity or abnormality which may interfere with the study participation;\n13. Pregnant or lactating females;\n14. History of alcohol abuse or drug abuse within the last year;\n15. Evidence of severe retinopathy (e.g. cytomegalovirus retinitis, macular degeneration) or clinically relevant ophthalmological disorder (due to diabetes mellitus or hypertension);\n16. Significant liver (AST or ALT \\> 2.5 times ULN) or renal disease (creatinine \\> 2 mg\u002Fml);\n17. History of major organ transplantation;\n18. History or presence of clinically significant neurologic diseases, e.g., uncontrolled severe seizure disorder;\n19. History of malignant disease, including solid tumors and hematological malignancies (except basal cell and squamous cell carcinomas of the skin and carcinoma in situ of the cervix that have been completely excised and are considered cured) within the last 3 years.","59 Years",{"count":486,"type":22},[568],"PHASE4","This is a randomized, open-label, multicenter, two-arm study to assess the efficacy and safety of ropeginterferon alfa-2b for patients with PV. The entire study period is 60 weeks, including a main treatment phase (32 weeks), an extension treatment phase (24 weeks), and a safety follow-up phase (four weeks). However, the study may be extended for additional period of treatment after Week 60 pending the primary endpoint analysis at Week 32. Approximately 70 patients with PV will be enrolled.",[28,248],[563,572,399,573,574,575,576],"MPNs","P1101","Hct","Phlebotomy","JAK2","2025-07-28",{"date":579,"type":33},"2025-07-31",{"date":581,"type":22},"2026-02-01",{"date":583,"type":22},"2027-06-30",{"name":585,"class":40},"PharmaEssentia",{"id":587,"slug":588,"hasResults":12,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":4,"eligibilityCriteria":592,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":593,"enrollmentInfo":594,"targetDuration":4,"studyType":23,"phases":595,"briefSummary":596,"conditions":597,"keywords":598,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":604,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":130},"100593874","phase-1-study-of-bebt-507-injection-in-subjects-with-polycythemia-vera-pv-100593874","NCT07012109","Study of BEBT-507 Injection in Subjects With Polycythemia Vera (PV)","A Multicenter, Open-Label Phase I Clinical Trial of BEBT-507 Injection in Subjects With Polycythemia Vera (PV)","Inclusion Criteria:\n\n1. Male and female subjects aged 18-75 years (inclusive);\n2. Subjects diagnosed with polycythemia vera (PV) according to the 2016 world health organization (WHO) criteria;\n3. Hydroxyurea-resistant\u002Fintolerant and\u002For interferon α-resistant\u002Fintolerant:\n\n1)Hydroxyurea-resistant or -intolerant Must meet the definition of hydroxyurea (HU) resistance or intolerance in the 2024 chinese society of clinical oncology (CSCO) Guidelines for the diagnosis and treatment of malignant hematological diseases and satisfy at least one of the following criteria:a) Resistance: Despite ≥3 months of HU treatment at a dose of ≥2 g\u002Fd, phlebotomy is still required to maintain HCT \\\u003C45%; after ≥3 months of HU treatment at a dose of ≥2 g\u002Fd, bone marrow proliferation remains uncontrolled (e.g., platelets \\>400×10⁹\u002FL and WBC \\>10×10⁹\u002FL); after ≥3 months of HU treatment at a dose of ≥2 g\u002Fd, a palpable massive splenomegaly fails to reduce by \\>50% or splenomegaly-related clinical symptoms do not fully resolve;b) Intolerance: At the minimum hydroxyurea (HU) dose required to achieve a complete or partial clinical hematologic response for the disease, absolute neutrophil count (ANC) \\\u003C1.0×10⁹\u002FL or PLT count \\\u003C100×10⁹\u002FL or Hemoglobin (HGB) \\\u003C100 g\u002FL occurs; during HU treatment at any dose, lower extremity ulcers or other intolerable non-hematological toxicities emerge, such as skin and mucous membrane manifestations (skin, teeth, or nail darkening; oral ulcers, mucositis; skin ulcers, rash, etc.), gastrointestinal symptoms (nausea, anorexia, indigestion, vomiting, abdominal pain, constipation, etc.), pneumonia, fever, etc.; 2)Interferon α-resistant or -intolerant Must satisfy at least one of the following criteria:a) Resistance: After achieving at least 12 weeks of interferon α therapy and a dose of at least 25×10⁶ U\u002Fweek (or the subject's maximum tolerated dose if it is less than 25×10⁶ U\u002Fweek), phlebotomy is still required to maintain HCT \\\u003C45%, or PLT \\>400×10⁹\u002FL and WBC \\>10×10⁹\u002FL, or palpable splenomegaly (starting \\>10 cm from the left costal margin) fails to reduce by \\>50%;b) Intolerance: At the minimum interferon α dose required for complete or partial clinical hematologic remission, ANC \\\u003C1.0×10⁹ or PLT \\\u003C100×10⁹ or hemoglobin \\\u003C100 g\u002FL (\\\u003C10 g\u002FdL) occurs, or depression, influenza-like symptoms, neuropsychiatric symptoms, autoimmune issues, or other unacceptable non-hematological toxicities related to interferon-alpha (IFN-α) emerge, defined as common terminology criteria for adverse events (CTCAE) V5.0 grade 3-4 events, or CTCAE V5.0 grade 2 events lasting over 1 week, or permanent discontinuation of interferon α, or interruption of interferon α until toxicity resolves, or hospitalization due to interferon α toxicity.\n\n4.The subject has intact skin at the injection site, and the investigator deems it is suitable for subcutaneous injection; 5.Eastern cooperative oncology group (ECOG) performance status score is 0, 1, or 2; 6.The subject has undergone bone marrow biopsy within 12 months prior to enrollment; 7.The subject or the subject's legal guardian has signed a written informed consent, and the subject is able to comply with the study requirements.\n\nExclusion Criteria:\n\n1. A history of intolerance to oligonucleotides, N-Acetylgalactosamine (GalNAc), or excipient components, or a history of intolerance to subcutaneous injections.\n2. Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) within 12 weeks before screening.\n3. Major bleeding event or blood transfusion for bleeding within 6 months before screening.\n4. Meets the international working group for myeloproliferative neoplasms research and treatment criteria for post-PV myelofibrosis.\n5. Received any investigational drug within 6 weeks before the first study drug administration, or not recovered from the effects of prior investigational drugs.\n6. Received any clinical studies or marketed products of GalNAc-targeted drugs within 48 weeks before the first study drug administration.\n7. Laboratory abnormalities:a) Liver function tests: alanine aminotransferase (ALT) or aspartate aminotransferase (AST)\\>2.0×Upper Limit of Normal (ULN), total bilirubin（TBIL）\\>1.5×ULN;b) Renal function tests: estimated glomerular filtration rate (eGFR)\\\u003C60 mL\u002Fmin\u002F1.73㎡ (Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation);c) Blood routine tests: platelet count\\>1000×10⁹\u002FL, WBC count\\>25×10⁹\u002FL;d) Coagulation tests: international normalized ratio (INR)\\>1.5×ULN;e) Others: presence of peripheral blood blasts.\n8. Subjects with symptomatic splenomegaly (e.g., splenic infarction, left upper quadrant fullness or pain, early satiety, portal hypertension).\n9. Due to potential genotoxicity, mutagenicity, and teratogenicity of the study drug, exclude:a) Men and women planning to conceive within 5 years without prior in vitro sperm\u002Fovum preservation;b) Pregnant or breastfeeding women;c) Women within 2 years of menopause unwilling to use acceptable contraception until 6 months after the last study drug dose.\n10. Presence of other active malignancies requiring treatment that may interfere with the study.\n11. Comorbid conditions:a) Poorly controlled diabetes (random glucose≥11.1mmol\u002FL or HbA1c≥8.5% despite antidiabetic treatment) assessed by the investigator;b) Severe pulmonary disease (CTCAE V5.0 grade III-IV);c) Severe cardiac disease (defined as any of the following:Left ventricular ejection fraction (LVEF) \\\u003C50% as determined by multigated acquisition scan (MUGA) or Echocardiogram (ECHO);QT interval corrected using the Fridericia method (QTcF) interval \\>450 ms for males or \\>470 ms for females;Unstable angina;Symptomatic pericarditis;Myocardial infarction within the past 6 months with persistent elevation of cardiac enzymes or evidence of persistent regional wall abnormalities on LVEF assessment;History of congestive heart failure (new york heart association functional class III-IV) or cardiomyopathy;d) Significant renal or hepatic impairment;e) Poorly controlled active hepatitis B or C, or other diseases with clinically significant active infections, including hepatitis B (HBV), hepatitis C (HCV), or syphilis. Active HBV is defined as Hepatitis B Surface Antigen (HBsAg) or Hepatitis B e Antigen (HBeAg) positivity with HBV DNA≥2000 IU\u002Fml (10⁴ copies\u002Fml). If HBV DNA is below this level, antiviral therapy is required until one year post - study. Active HCV is defined as HCV RNA above the assay's upper limit. For syphilis, a positive non-treponemal test requires confirmation with a treponemal antibody test. If the latter is negative and the investigator confirms past infection with syphilitic cure, the subject can be included;f) Known human immunodeficiency virus （HIV） positivity or primary immunodeficiency;g) Deemed unsuitable for study participation due to a history of psychosis, family history of psychiatric illness, or mood disorders, as determined by the investigator or psychiatrist;h) Uncontrolled hypertension (systolic BP≥180mmHg and\u002For diastolic BP≥110mmHg);i) Severe medical conditions with a risk of major bleeding or history of major bleeding.\n12. Concomitant use of drugs that may prolong the QT interval or cause torsades de pointes.\n13. History of alcohol or drug abuse within the past year.\n14. Subjects deemed unsuitable for this treatment regimen by the investigator.","75 Years",{"count":205,"type":22},[272],"This is a multicenter, open-label Phase I clinical trial of BEBT-507 in subjects with polycythemia vera(PV). Phase Ia is a single-agent dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), preliminary efficacy, and pharmacodynamics of BEBT-507 in subjects with PV . Based on the results of Phase Ia, two doses will be selected for further evaluation in Phase Ib to assess the efficacy, safety, and PK profile of BEBT-507 in subjects with PV , and to recommend a dose for Phase III clinical trials.",[28],[599,600,601,602],"BEBT-507","Safety","Pharmacokinetics","Efficacy","2025-05-30",{"date":605,"type":33},"2025-06-10",{"date":607,"type":22},"2025-06-05",{"date":609,"type":22},"2028-07-31",{"name":611,"class":40},"BeBetter Med Inc",{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":616,"acronym":4,"eligibilityCriteria":617,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":618,"targetDuration":4,"studyType":23,"phases":620,"briefSummary":621,"conditions":622,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":624,"lastUpdatePostDateStruct":625,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":4},"100587075","prevalence-of-germline-gene-mutations-in-patients-with-myeloproliferative-neoplasms-with-family-history-100587075","NCT06923670","Prevalence Of Germline Gene Mutations In Patients With Myeloproliferative Neoplasms With Family History","Inclusion Criteria:\n\n\\*Patients \\>18 years\n\n* Diagnosis of MPN (Essential Thrombocythemia, Polycythemia Vera, Myelofibrosis) confirmed according to ICC 2022 criteria\n* Familiarity for myeloid neoplasia: at least one first or second degree relative affected by myeloid neoplasia (probands) OR presence of matching criteria with a proband (controls). Each center will be able to contribute with its own available patients\u002Frelatives, providing the clinical-laboratory data required by the study.\n\n  * Signing of informed consent according to ICH\u002FEU\u002FGCP and local national laws (if applicable)\n\nExclusion Criteria:\n\n* Patients \\\u003C18 years Patients with other hematological diagnoses; • Lack of informed consen",{"count":619,"type":22},496,[101],"Philadelphia-negative myeloproliferative neoplasms (MPNs) occur sporadically and are due to somatic mutations in the JAK2 (Janus kinase 2), CALR (calreticulin) and MPL (thrombopoietin receptor) genes. However, data from epidemiological and family studies clearly highlight a heritable component that influences the risk of developing MPN and potentially contributes to the observed phenotypic pleiotropy. Genome-wide association studies in MPN familial clusters have identified a number of germline genetic variants associated with an increased risk of developing MPN. The strongest association discovered so far is the presence of the JAK2 46\u002F1 haplotype and, subsequently, several studies have found additional variants in other genes, particularly in the TERT gene.\n\nThe aim of the study would be to investigate the presence of germline mutations in MPN patients selected on the basis of a family history of myeloid neoplasms through the analysis of both already recognized genes and other potentially implicated ones.",[28,623,145],"Essential Thrombocythaemia","2025-05-14",{"date":626,"type":33},"2025-05-15",{"date":628,"type":22},"2025-05-21",{"date":630,"type":22},"2028-05-01",{"name":632,"class":89},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":634,"slug":635,"hasResults":12,"nctId":636,"briefTitle":637,"officialTitle":638,"acronym":4,"eligibilityCriteria":639,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":640,"targetDuration":4,"studyType":23,"phases":641,"briefSummary":642,"conditions":643,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":644,"lastUpdatePostDateStruct":645,"startDateStruct":647,"completionDateStruct":649,"leadSponsor":650,"locationsCount":652},"100573935","phase-1-a-study-of-safety-tolerability-pharmacokinetics-pharmacodynamics-and-immunogenicity-of-9mw3011-in-patients-with-polycythemia-vera-100573935","NCT06752746","A Study of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 9MW3011 in Patients With Polycythemia Vera","A Phase Ib, Multicenter, Randomized, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 9MW3011 in Patients With Polycythemia Vera","Inclusion Criteria:\n\n1. Male and female patients aged 18 years or older at the time of screening.\n2. A confirmed diagnosis of PV according to the revised 2016 World Health Organization criteria and are resistant to or intolerant of hydroxyurea or Interferon alpha.\n3. Have a treatment history for PV with resistance or intolerance to hydroxyurea or Interferon alpha.\n4. Subjects receiving hydroxyurea, Interferon alpha, or ruxolitinib must complete a washout period before administration of the investigational drug.\n5. Must agree to adhere to appropriate contraception requirements during the study period.\n6. All female subjects with fertility capacity tested negative for blood pregnancy.\n7. Voluntarily participate in clinical trials and agrees to participate in the study by giving written informed consent.\n\nExclusion Criteria:\n\n1. The spleen is palpable at least 5 centimeters below the left costal margin upon palpation at baseline.\n2. Heart failure, unstable angina pectoris, myocardial infarction, and other thrombotic diseases within the 6 months prior to screening.\n3. Abnormal QTc interval of electrocardiogram within the 6 months prior to screening.\n4. Uncontrolled hypertension prior to screening.\n5. Any non-PV myeloproliferative neoplasms (MPN).\n6. Blast cells and blast granulocytes in the peripheral blood within the 3 months prior to screening.\n7. Hematological indicators do not meet the requirements at the time of screening.\n8. Known positive for active hepatitis B, hepatitis C, syphilis or human immunodeficiency virus (HIV) infection.\n9. History of invasive malignancies within the last 5 years.\n10. Severe infection or uncontrolled active infection.\n11. Other hematological and lymphatic system diseases or any diseases causing hemolysis or erythrocyte instability.\n12. Other systemic diseases or a family history of systemic diseases, may affect the subject's safety or any other diseases and physiological conditions that may affect the results of the study, judged by the investigator.\n13. Specific history of allergies.\n14. Subjects who have used monoclonal antibodies within the 6 months prior to screening.\n15. Patients who have received vaccinations within 6 weeks prior to screening.\n16. Subjects who have received other antitumor therapeutic drugs for PV prior to screening.\n17. Chronic diseases requiring treatment with systemic glucocorticoids or other immunosuppressants.\n18. History of drug abuse or illicit drug use within 3 months prior to screening.\n19. Participation in other clinical trials within 3 months prior to screening.\n20. Planned elective surgery during the study.\n21. History of surgery within 3 months prior to screening.\n22. Intolerable iron deficiency-related symptoms judged by the investigator prior to the first dosing.\n23. Pregnant or lactating females; women of reproductive age who are not using effective contraception.\n24. Individuals directly associated with the research and\u002For their immediate family members.\n25. Other factors which may potentially affect the assessment of the study results by the investigator.",{"count":542,"type":22},[272],"The goal of this clinical trial is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of 9MW3011 in Chinese patients with Polycythemia Vera（PV）.",[28],"2025-05-06",{"date":646,"type":33},"2025-05-11",{"date":648,"type":33},"2024-03-21",{"date":32,"type":22},{"name":651,"class":40},"Mabwell (Shanghai) Bioscience Co., Ltd.",6,{"id":654,"slug":655,"hasResults":12,"nctId":656,"briefTitle":657,"officialTitle":658,"acronym":659,"eligibilityCriteria":660,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":661,"targetDuration":663,"studyType":296,"phases":4,"briefSummary":664,"conditions":665,"keywords":672,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":678,"lastUpdatePostDateStruct":679,"startDateStruct":681,"completionDateStruct":683,"leadSponsor":685,"locationsCount":130},"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":662,"type":22},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.",[666,667,668,28,669,300,670,671],"Erythrocytosis","Polycythemia","Polycythemia Secondary","Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase","Polycythemia; Familial","Polycythemia, Primary",[673,361,666,667,674,675,676,677],"Prospective","Patient Registry","Diagnosis","Management","Outcomes","2025-01-19",{"date":680,"type":33},"2025-01-21",{"date":682,"type":22},"2025-02-01",{"date":684,"type":22},"2030-12-31",{"name":686,"class":89},"Cyrus Hsia",{"id":688,"slug":689,"hasResults":12,"nctId":690,"briefTitle":691,"officialTitle":692,"acronym":4,"eligibilityCriteria":693,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":694,"targetDuration":4,"studyType":23,"phases":696,"briefSummary":697,"conditions":698,"keywords":699,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":703,"lastUpdatePostDateStruct":704,"startDateStruct":706,"completionDateStruct":708,"leadSponsor":710,"locationsCount":130},"100572543","efficacy-and-safety-of-peginterferon-in-et-and-pv-100572543","NCT06734637","Efficacy and Safety of Peginterferon in ET and PV.","A Single-arm, Single-center Study to Explore the Safety and Efficacy of Pegylated Interferon Alpha in Chinese Patients With ET (Essential Thrombocythemia) and PV (Polycythemia Vera).","Inclusion Criteria:\n\n1. Meet the 2016 WHO diagnostic criteria for ET (Essential Thrombocythemia) and PV (Polycythemia Vera)\n\n   * ET (Essential Thrombocythemia) major criteria:\n\n     1. Platelet count \\> 450 \\* 10\\^9\u002FL; (2) Bone marrow biopsy shows marked megakaryocytic proliferation with increased mature megakaryocyte volume and increased nuclear lobulation. There is no significant granulocytic proliferation, left shift, or erythroid proliferation, with grade 1 fibrosis observed in a few cases; (3) Does not meet the WHO diagnostic criteria for BCR-ABL1+ CML, PV, PMF, MDS, or other myeloproliferative neoplasms; (4) JAK2, CALR, or MPL mutation positive.\n\n        Secondary criteria: (1) Presence of a clonal marker or absence of evidence for reactive thrombocytosis.\n\n        The diagnosis of ET requires the fulfillment of all four main criteria, or the first three main criteria plus one secondary criterion.\n   * PV (Polycythemia Vera) main criteria: (1) Hemoglobin \\> 16.5 g\u002FdL in males, \\> 16 g\u002FdL in females, or Hematocrit \\> 49% in males, \\> 48% in females, or an increase in red cell volume of 25% or more above the normal value; (2) Bone marrow biopsy shows increased cellularity inappropriate for age, with marked erythroid, granulocytic, and megakaryocytic proliferation, and the presence of mature megakaryocytes of varying sizes and morphologies; (3) JAK2 V617F mutation positive or JAK2 exon 12 mutation positive.\n\n   Secondary criteria: Serum Epo (Erythropoietin) level below the lower limit of the normal range.\n\n   The diagnosis of PV requires the fulfillment of three major criteria, or the first two main criteria plus one secondary criterion.\n2. For ET patients, the criteria for cytoreductive therapy must be met, as follows:\n\n(1) For patients without a history of thrombosis: Age ≥ 60 years, regardless of the presence of cardiovascular risk (CVR) or JAK2V617 mutation; Any age with a platelet count \\> 1500 × 109\u002FL. (2) For patients with a history of arterial thrombosis: Any age, regardless of the presence of CVR and JAK2V617 mutation; (3) For patients with a history of venous thrombosis: Any age, regardless of the presence of CVR and JAK2V617 mutation; 3.ECOG score ≤ 2. 4.Cardiac ejection fraction (EF) ≥ 60%. 5.The participant voluntarily signs the informed consent form.\n\nExclusion Criteria:\n\n* Previous treatment with Peginterferon α-2b.\n* ET patients who do not meet the criteria for cytoreductive therapy as per the 2016 Chinese Expert Consensus on Primary Thrombocythemia.\n* Allergy to the active ingredient, α-interferon, or any excipients of this product.\n* History of psychiatric illness, or allergy to interferon.\n* Plasma total bilirubin greater than twice the normal value.\n* Severe cardiac disease, liver insufficiency, chronic kidney disease, and neurological disorders (such as depression or mania).\n* History of other malignant tumors within the past three years.\n* Autoimmune chronic hepatitis.\n* Any condition deemed unsuitable for inclusion by the investigator.",{"count":695,"type":22},40,[101],"This is a single-arm, single-center study aims to recruit 40 participants with Essential Thrombocythemia (ET) and Polycythemia Vera (PV). Eligible participants will receive a subcutaneous injection of Peginterferon α-2b 180 mcg once a week and follow-up，and efficacy and safety will be evaluated.",[170,28],[700,701,702],"Essential thrombocythemia","Polycythemia vera","Peginterferon α-2b","2024-12-11",{"date":705,"type":33},"2024-12-16",{"date":707,"type":33},"2024-11-20",{"date":709,"type":22},"2027-11-20",{"name":711,"class":89},"Zhenya Hong",{"id":713,"slug":714,"hasResults":12,"nctId":715,"briefTitle":716,"officialTitle":717,"acronym":4,"eligibilityCriteria":718,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":719,"targetDuration":720,"studyType":296,"phases":4,"briefSummary":721,"conditions":722,"keywords":730,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":736,"lastUpdatePostDateStruct":737,"startDateStruct":739,"completionDateStruct":741,"leadSponsor":743,"locationsCount":130},"100267393","myeloproliferative-neoplasms-mpns-patient-registry-100267393","NCT02760238","Myeloproliferative Neoplasms (MPNs) Patient Registry","Clinical and Molecular Epidemiology of Myeloproliferative Neoplasms (MPNs)","Inclusion Criteria:\n\nDiagnosis of one of the following myeloproliferative neoplasms (MPNs):\n\n* Atypical CML (aCML)\n* Chronic eosinophilic leukemia-not otherwise specified (CEL, NOS),\n* Chronic myelomonocytic leukemia (CMML)\n* Chronic neutrophilic leukemia (CNL),\n* Essential thrombocythemia (ET),\n* Juvenile myelomonocytic leukemia (JMML),\n* Mastocytosis, MPN unclassifiable\n* MPN\u002FMDS unclassifiable,\n* Primary myelofibrosis (PMF),\n* Post-essential thrombocythemia myelofibrosis (post-ET MF),\n* Post-polycythemia vera MF (post-PV MF)\n* Refractory anemia with ringed sideroblasts associated with marked thrombocytosis (RARS-T)\n\nExclusion Criteria:\n\n* None",{"count":295,"type":22},"10 Years","The mandate of this MPN registry is to collect clinical information, including molecular results, from consenting patients with a variety of MPNs at different time points during the course of their disease.",[144,28,170,723,724,725,726,727,728,729],"Mastocytosis","Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative","Leukemia, Myelomonocytic, Juvenile","Chronic Eosinophilic Leukemia-not Otherwise Specified","Myelodysplastic-Myeloproliferative Diseases","Neoplasms","Leukemia, Myelomonocytic, Chronic",[402,731,732,733,734,735,728],"myelodysplastic syndrome","registry","leukemia","Bone Marrow Diseases","Hematologic Diseases","2024-08-26",{"date":738,"type":33},"2024-08-27",{"date":740,"type":4},"2015-04",{"date":742,"type":22},"2027-10-31",{"name":744,"class":89},"University Health Network, Toronto"]