[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myelofibrosis-pmf\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myelofibrosis-pmf":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100503454","phase-2-reparixin-in-patients-with-myelofibrosis-myeloproliferative-neoplasms-research-consortium-mpn-rc-120-100503454",false,"NCT05835466","Reparixin in Patients With Myelofibrosis Myeloproliferative Neoplasms Research Consortium (MPN-RC 120)","Phase II Study of Reparixin in Patients With Myelofibrosis Myeloproliferative Neoplasms Research Consortium [MPN-RC 120]","Inclusion Criteria:\n\n* Be ≥ 18 years of age at time of signing the informed consent form (ICF)\n* Willing to voluntarily sign the ICF\n* Have a pathologically confirmed diagnosis of PMF, post-ET-MF, or post-PV-MF as per the World Health Organization (WHO) diagnostic criteria with intermediate-2 or higher risk disease by DIPSS\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Willing to undergo a bone marrow biopsy at screening\n\n  o A bone marrow biopsy obtained within 90 days of screening without intervening treatments and approved by the study chair may suffice.\n* Be refractory\u002Fresistant to or intolerant of\u002Finappropriate for JAKi therapy as defined by at least one of the following:\n\n  * Treatment for ≥ 3 months with inadequate efficacy as demonstrated by persistent palpable splenomegaly ≥ 5cm or symptoms related to splenomegaly,\n  * Treatment for ≥ 28 days complicated by either:\n  * Development of a red blood cell transfusion requirement (at least 2 units\u002Fmonth for 2 months)\n  * CTCAE grade ≥ 3 AEs of thrombocytopenia, anemia, hematoma, or hemorrhage while being treated with a JAKi\n  * Development of non-hematological toxicity that makes patient intolerant of JAKi therapy\n  * In the Investigator's judgment, are not candidates for available approved JAKi\n* Recovery to ≤ Grade 1 or baseline of any toxicities due to prior systemic treatments, excluding alopecia\n* At least two weeks must have elapsed between the last dose of any MF-directed drug treatments or other investigational therapies and start of reparixin\n\n  o Participants may continue hydroxyurea until the day prior to C1D1 if needed for disease control\n* Have adequate organ function as demonstrated by the following:\n\n  * ALT (SGPT) and\u002For AST (SGOT) ≤ 3x upper limit of normal (ULN), or ≤ 4 x ULN (if upon judgment of the treating physician, it is believed to be due to MF-related EMH);\n  * Direct bilirubin ≤ 1.5 x ULN; or ≤ 2x ULN (if upon judgment of the treating physician, it is believed to be due to MF-related EMH or documented Gilbert's syndrome);\n  * Creatinine clearance ≥ 40 mL\u002Fmin;\n  * Platelet count ≥ 25 x 109\u002FL;\n  * Bone marrow and peripheral blood blast count \\\u003C 10%;\n  * ANC ≥ 1000 mm3.\n* Life expectancy of at least six months\n* Women of childbearing potential (WCBP) and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 120 days following completion of therapy. WCBP must also have a negative serum pregnancy test at screening and Cycle 1 Day 1. Should a woman become pregnant or suspect she is pregnant while participating, she should inform her treating physician immediately. (Section 5.9.2)\n\n  o Men must agree to use a condom and not father a child or donate sperm for the duration of the study and for 120 days after the last dose of study therapy\n* Ability to adhere to the study visit schedule and all protocol requirements\n\nExclusion Criteria:\n\n* History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months\n* Other invasive malignancies within the last 3 years, except non-melanoma skin cancer and localized cured prostate and cervical cancer\n* Moderate or severe cardiovascular disease meeting one or both of the below criteria:\n\n  * Presence of cardiac disease, including a myocardial infarction within 6 months prior to study entry, unstable angina pectoris, New York Heart Association Class III\u002FIV congestive heart failure, or uncontrolled hypertension\n  * Documented major electrocardiogram (ECG) abnormalities (not responding to medical treatments)\n* Presence of active serious infection\n* Any serious, unstable medical or psychiatric condition that would prevent (as judged by the Investigator) the participant from signing the ICF or any condition, including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he\u002Fshe were to participate in the study or confounds the ability to interpret data from the study\n* Participants who have undergone a hematopoietic cell transplant (HCT) within 100 days of the first dose of study therapy, participants on immunosuppressive therapy post-HCT at screening, use of calcineurin inhibitors within 4 weeks prior to first dose of study therapy, or participants with clinically significant graft-versus-host disease (GVHD)\n\n  o Note: The use of topical steroids or \\\u003C 10mg oral prednisone for ongoing skin GVHD is permitted\n* Known history of human immunodeficiency virus (HIV), or known active hepatitis A, B, or C infection\n* Impairment of gastrointestinal (GI) function or GI disease that could significantly alter the absorption of reparixin, including any unresolved nausea, vomiting, or diarrhea \\> CTCAE grade 1\n* Is or has an immediate family member (e.g., spouse, parent\u002Flegal guardian, sibling, or child) who is investigational site or sponsor staff directly involved with this trial, unless prospective institutional review board (IRB) approval (by chair or designee) is given allowing exception to this criterion for a specific participant\n* Organ transplant recipients other than bone marrow transplant\n* Women who are pregnant or lactating\n* History of splenectomy\n* Known hypersensitivity to sulfonamides\n\n  o Hypersensitivity to sulphanilamide antibiotics alone (e.g. sulfamethoxazole) does not qualify for exclusion\n* Known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAID), including ibuprofen","ALL","18 Years",{"count":19,"type":20},10,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is an open label, phase II study to assess the efficacy, safety, and tolerability of Reparixin in patients with DIPSS intermediate-2, or high-risk primary myelofibrosis (PMF), post essential thrombocythemia\u002Fpolycythemia vera related MF (Post ET\u002FPV MF) after prior treatment, and those who are ineligible or refuse treatment, with a Janus kinase inhibitor (JAKi). 26 patients will be enrolled. Eligible patients will receive oral reparixin three times daily on a 4-week cycle for a core study period of 6 cycles (24 weeks). After cycle 6, patients may continue receiving reparixin once daily on a 4-week cycle if at least stable disease (SD) is met by IWG-MRT criteria until loss of response, disease progression, unacceptable toxicity, patient\u002Fphysician withdrawal, or termination of study by sponsor.",[26,27,28],"Myelofibrosis (PMF)","Post Essential Thrombocythemia Myelofibrosis (ET-MF)","Post Polycythemia Vera Related Myelofibrosis (PV-MF)","RECRUITING","2026-05-05",{"date":32,"type":33},"2026-05-06","ACTUAL",{"date":35,"type":33},"2023-07-24",{"date":37,"type":20},"2028-12-01",{"name":39,"class":40},"Icahn School of Medicine at Mount Sinai","OTHER",9,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":108,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":5},"100620792","mpn-progression-registry-observational-study-tracking-symptoms-treatments-and-disease-progression-in-people-with-myeloproliferative-neoplasms-mpns-100620792","NCT07362225","MPN PROGRESSion Registry: Observational Study Tracking Symptoms, Treatments, and Disease Progression in People With Myeloproliferative Neoplasms (MPNs)","The MPN PROGRESSion Registry: A Retrospective and Prospective Observational Study Collecting Patient-Reported Outcomes, Electronic Health Records, and Claims Data to Track Symptoms, Treatments, and Disease Progression in Individuals Diagnosed With Myeloproliferative Neoplasms (MPNs).","Inclusion Criteria:\n\n* Adults aged 18 years or older at the time of enrollment.\n* Confirmed diagnosis of a myeloproliferative neoplasm (MPN), including one or more of the following subtypes, according to WHO 2022 criteria, including patients originally diagnosed with one of these conditions but who have received one or more stem cell transplants (SCTs) or bone marrow transplants (BMTs):\n* Polycythemia vera (PV)\n* Essential thrombocythemia (ET)\n* Primary myelofibrosis (PMF)\n* Secondary myelofibrosis (post-ET or post-PV MF)\n* Pre-fibrotic primary myelofibrosis (pre-PMF)\n* Myeloproliferative neoplasm-unclassifiable (MPN-U)\n* Myeloproliferative neoplasm, accelerated phase (MPN-AP)\n* Myeloproliferative neoplasm, blast phase (MPN-BP)\n* Post-MPN acute myeloid leukemia (AML)\n* Myelodysplastic syndrome (MDS)\u002FMPN overlap syndrome\n* Myeloproliferative neoplasm, blast phase (MPN-BP)\n* Ability to provide informed consent electronically or through a legally authorized representative.\n* Willingness to share health information, including electronic health records (EHR), laboratory values, and survey responses.\n* Willingness to complete periodic patient-reported outcome (PRO) surveys and symptom tracking assessments.\n\nExclusion Criteria:\n\n* Individuals under 18 years of age.\n* Inability to provide informed consent, either directly or through a legally authorized representative.\n* Currently enrolled in an interventional clinical trial where participation would interfere with the ability to participate in this observational registry (based on investigator or sponsor judgment).\n* Any condition that, in the judgment of the study team, would make participation in the registry infeasible or unsafe.",{"count":50,"type":20},5000,"OBSERVATIONAL","The MPN PROGRESSion Registry is a multi-year, observational research study designed to improve understanding of myeloproliferative neoplasms (MPNs)-a group of rare, chronic blood cancers that include polycythemia vera (PV), essential thrombocythemia (ET), primary myelofibrosis (MF), pre-fibrotic primary myelofibrosis (pre-PMF), secondary myelofibrosis, myeloproliferative neoplasm-unclassifiable (MPN-U), MPN in accelerated phase (MPN-AP), and MPN in blast phase (MPN-BP), post-MPN Acute Myeloid Leukemia (AML), and MDS\u002FMPN overlap syndrome as defined above per WHO 2022 criteria, including patients originally diagnosed with one of these conditions but who have received one or more SCTs and\u002For BMTs . These conditions are characterized by abnormal blood cell production in the bone marrow and may lead to complications such as blood clots, bleeding, bone marrow fibrosis, and, in some cases, progression to acute leukemia.\n\nThe central hypothesis of the registry is that collecting and analyzing real-world, longitudinal data-including electronic health records (EHRs), laboratory values, treatments, and patient-reported outcomes (PROs)-from a diverse population of people living with MPNs will help identify patterns and predictors of disease progression, treatment response, quality of life, and long-term outcomes. These insights are intended to guide future research, inform clinical guidelines, and support improvements in patient care.\n\nThe registry is non-interventional and observational; participants do not receive investigational treatments, and all medical care continues under the supervision of their own physicians. Data collection includes EHRs, PRO surveys, patient-reported symptom and lab tracking, insurance claims, and, in the future, may include linkages with other relevant disease registries and datasets. Potential collaborations under consideration include those with the European LeukemiaNet (ELN) MPN Registry, the Mayo Clinic MPN Database, the Center for International Blood and Marrow Transplant Research (CIBMTR), the SEER Program, Harmony Alliance Foundation, and the National Cancer Database (NCDB).\n\nThe registry emphasizes the patient voice, incorporating lived experiences related to hallmark MPN symptoms such as fatigue, pruritus (itching), bone pain, night sweats, and social and emotional impacts. Participants will be followed for at least five years, with many enrolled for ten years or longer, to capture the natural history of disease and long-term outcomes. PRO surveys will be completed approximately every six months, and EHR data will be regularly reviewed to track changes in clinical status, treatment, and disease evolution.\n\nStatistical analyses will use descriptive and inferential methods to examine clinical characteristics, symptom burden, disease trajectories, and patient-centered outcomes. Planned subgroup analyses may compare differences across diagnoses, treatment approaches, demographics, or genomic factors. Analytic plans will be finalized during the course of the study and may evolve in response to emerging scientific questions.\n\nThe registry is open to adults (18 years or older) living in the United States who have been diagnosed with any of the included MPN subtypes and are willing to share health information and complete study surveys. Individuals currently enrolled in interventional clinical trials or unable to provide informed consent may be excluded. Participation is voluntary, and participants may withdraw from the study at any time without affecting their medical care.\n\nPrivacy and data security are core priorities. Participant data will be securely stored and managed in accordance with all applicable privacy laws and research regulations. No identifiable information will be shared with external parties without appropriate authorization. Oversight is provided by a Steering Committee and a Patient Engagement Advisory Committee (PEAC), ensuring rigorous scientific, ethical, and patient-centered governance.\n\nThe registry is sponsored by the MPN Research Foundation, a nonprofit organization advancing research and patient advocacy in myeloproliferative neoplasms (MPNs). Participants can contact the registry team at any time with questions and will receive periodic updates on study findings.\n\nThis study aims to address critical gaps in understanding the real-world experiences of people with MPNs-such as symptom burden over time, risk factors for progression, and how different treatments impact patient outcomes. Findings may inform clinical trial design, support biomarker discovery, and contribute to the development of updated treatment recommendations. The registry is committed to including participants from diverse backgrounds and clinical settings to ensure findings are broadly applicable across the MPN community. Summary results will be shared through scientific publications, presentations, and other dissemination efforts to advance MPN research and care globally.",[54,55,56,57,58,59,60,61,62,63,64,26,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107],"Polycythemia Vera","ET (Essential Thrombocythemia)","Polycythemia Vera (PV)","Essential Thrombocythemia (ET)","Primary Myelofibrosis (MF)","Primary Myelofibrosis (PMF)","Myelofibrosis","Myelofibrosis (MF)","Myelofibrosis, Primary","Myelofibrosis, Post ET","Myelofibrosis, Post PV","Myelofibrosis，MF","Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis","Myelofibrosis Due to and Following Polycythemia Vera","Myelofibrosis Transformation in Essential Thrombocythemia","Myelofibrosis With High Molecular Risk Mutations","MF","Secondary Myelofibrosis","Secondary Myelofibrosis in Myeloproliferative Disease","Secondary Myelofibrosis (Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis)","Post-Polycythemia Vera Myelofibrosis","Post-polycythemia Vera Myelofibrosis (PPV-MF)","Post-polycythemia Vera Myelofibrosis (Post-PV MF)","Post-polycythemia Vera Myelofibrosis(Post-PV MF)","Post-PV MF","Post-Essential Thrombocythemia Myelofibrosis","Post-essential Thrombocythemia Myelofibrosis (PET-MF)","Post-essential Thrombocythemia Myelofibrosis(Post-ET MF)","Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)","Post-ET MF","Pre-fibrotic Myelofibrosis","Myeloproliferative Disorder","Myeloproliferative Disorders","Myeloproliferative Disorders (MPD)","Myeloproliferative Neoplasms (MPNs)","Myeloproliferative Neoplasm(MPN)-Associated Myelofibrosis","Myeloproliferative Neoplasm With 10% Blasts or Higher","Myeloproliferative Neoplasms","MPN","MPN (Myeloproliferative Neoplasms)","MPN-associated Myelofibrosis","Myeloproliferative Neoplasm, Unclassifiable","Myeloproliferative Neoplasm, Not Otherwise Specified","Accelerated Phase MPN","Accelerated Phase Myeloproliferative Neoplasm","Blast Phase MPN","Blast Phase Myeloproliferative Neoplasm","Thrombocythemia Myelofibrosis (PET-MF)","Thrombocythemia, Essential","Thrombocythemia, Hemorrhagic","Agnogenic Myeloid Metaplasia","Chronic Idiopathic Myelofibrosis","Idiopathic Myelofibrosis","MDS\u002FMPN Crossover Syndromes",[91,54,109,71,110,85,95,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139],"Essential Thrombocythemia","Pre-fibrotic Primary Myelofibrosis","Myeloproliferative Neoplasm, Accelerated Phase","Myeloproliferative Neoplasm, Blast Phase","Chronic Myeloproliferative Disease","Hematologic Neoplasms","Bone Marrow Neoplasms","Blood Cancer","Disease Progression","Biomarker Discovery","Patient-Reported Outcomes","Electronic Health Records","Real-World Evidence","Longitudinal Study","Observational Study","Registry Study","Natural History Study","Quality of Life","Rare Diseases","Chronic Hematologic Diseases","Risk Stratification","Symptom Burden","Medical Claims Data","Longitudinal Data Collection","Patient-Centered Research","Health Outcomes Research","Clinical Outcomes","Clinical Guidelines Development","Regulatory Science","Drug Development","Treatment Response","2026-01-15",{"date":142,"type":33},"2026-01-23",{"date":144,"type":33},"2025-09-26",{"date":146,"type":20},"2035-09-08",{"name":148,"class":40},"MPN Research Foundation"]