[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myelofibrosis-mf\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myelofibrosis-mf":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,43,79,113,139,163,190,216,249,351,370,391],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100584320","phase-1-a-study-of-roginolisib-in-combination-with-ruxolitinib-in-patients-with-myelofibrosis-mf-who-are-unresponsive-to-jak-inhibitors-100584320",false,"NCT06887803","A Study of Roginolisib in Combination With Ruxolitinib in Patients With Myelofibrosis (MF) Who Are Unresponsive to JAK Inhibitors","A Phase I\u002FII Open-Label, Multi-centre Study to Assess the Safety and Tolerability of Roginolisib in Combination With Ruxolitinib in Patients With Myelofibrosis (MF) Who Are Unresponsive to an Approved JAK Inhibitors (HEMA-MED)","HEMA-MED","Inclusion Criteria:\n\n1. ≥18 years of age inclusive, at the time of signing the informed consent.\n2. Capable of giving signed informed consent, which includes compliance with the requirements of this protocol.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n4. Diagnosis of MF, Post-Polycythaemia Vera Myelofibrosis MF (PPV-MF), or post-essential thrombocythemia MF (PET-MF)\n5. Dynamic International Prognostic Scoring System (DIPSS) risk category of intermediate-1, intermediate-2, or high\n6. Treated with ruxolitinib for ≥ 3 months with a stable dose ≥ 10 mg for a minimum of 8 weeks prior to Day 1. Furthermore, patients must show an unsatisfactory spleen reduction, such as a reduction of less than 25%, and spleen must be palpable ≥ 10 cm below the left costal margin on physical examination\n7. Did not receive experimental drug therapy for MF or any other drug considered as an effective treatment for MF (e.g., danazol, hydroxyurea, interferon products) with the exception of ruxolitinib, within 3 months of starting study drug (except in conditions where other effective treatments for MF were completed 6 months prior to starting ruxolitinib)\n8. Independent of spleen size, active symptoms of MF at the screening visit, as demonstrated by the presence of a Total Symptom Score (TSS) of ≥ 10 using the Screening Symptom Form.\n9. Peripheral blast count \\\u003C 10%\n10. Act to avoid pregnancy or fathering children based on the criteria below:\n\n    1. Women of non-childbearing potential (i.e., surgically sterile with a hysterectomy and\u002For bilateral oophorectomy OR ≥ 12 months of amenorrhea and at least 50 years of age).\n    2. Women of childbearing potential who had a negative serum pregnancy test at screening and who agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through safety follow-up, at least 1 month after the last dose of study treatment. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the patient and their understanding confirmed.\n    3. Men who agree to take appropriate precautions to avoid fathering from screening through safety follow-up, at least 1 month after the last dose of study treatment. Permitted methods that are at least 99% effective in preventing pregnancy (see Appendix 3) should be communicated to the patient and their understanding confirmed.\n\nExclusion Criteria:\n\n1. Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications.\n2. History of a prior Grade 3 or 4 AE which did not respond to therapy or resolved with treatment interruptions and returned to at least Grade 1, other than fatigue. Note: Patients with ≤ Grade 2 neuropathy or alopecia are an exception and may enrol.\n3. Active autoimmune process (e.g., rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease, immune colitis) for which systemic treatment (i.e., use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) is required. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n4. History or presence of an abnormal ECG that, in the Investigator's opinion, is clinically meaningful. Screening QTc interval \\> 480 milliseconds is excluded (corrected by Fridericia). In the event that a single QTc is \\> 480 milliseconds, the patient may enrol if the average QTc for the 3 ECGs is \\\u003C 480 milliseconds. For patients with an intraventricular conduction delay (QRS interval \\> 120 msec), the JTc interval may be used in place of the QTc with Sponsor approval. The JTc must be \\\u003C 340 milliseconds if JTc is used in place of the QTc. Patients with left bundle branch block are excluded.\n5. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke (\\\u003C 6 months prior to enrolment), myocardial infarction (\\\u003C 6 months prior to enrolment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.\n6. Patients with active malignancy requiring concurrent intervention or previous malignancies unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required during the study period and the patient is assessed at low risk of relapse by the investigator. Note: Patients with a slow progressing cancer (e.g. prostate) or an in situ cancers (e.g. cervical dysplasia) are permitted.\n7. Any serious or uncontrolled medical disorder or active infection that, in the opinion of the Investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the patient to receive protocol therapy.\n8. Use of the following treatments within the time periods noted:\n\n   1. Erythropoiesis stimulating agent (ESA) within 4 weeks prior to start of roginolisib.\n   2. Splenic irradiation within 3 months prior to start of roginolisib.\n9. Major surgery within 2 weeks of the first dose of study drug (minimally invasive procedures such as bronchoscopy, bone marrow biopsy, insertion of a central venous access device, and insertion of a feeding tube are not considered major surgery and are not exclusionary)\n10. Receiving an immune-suppressive based treatment for any reason (including chronic use of systemic corticosteroid at doses \\> 10 mg\u002Fday prednisone equivalent) within 14 days prior to the first dose of study treatment. Use of inhaled or topical steroids (including but not limited to creams or intra-articular injection) or brief corticosteroid use for radiographic procedures or systemic corticosteroids ≤ 10 mg is permitted.\n11. Have received a live vaccine within 30 days of planned start of study therapy while on trial. Other type of vaccines, including SARS-Co2 vaccines, are allowed.\n12. Known allergy or reaction to any component of either study drugs or formulation components.\n13. Currently breastfeeding.\n14. Known alcohol or other substance abuse.\n15. Laboratory and medical history parameters not within Protocol-defined range.\n\n    1. Absolute neutrophil count \\\u003C 1.5 × 109\u002FL.\n    2. Platelet count \\\u003C 100 × 109\u002FL.\n    3. Haemoglobin \\\u003C 8 g\u002FdL (transfusion is acceptable to meet this criterion).\n    4. Serum creatinine ≥ 1.5 × institutional ULN or measured or calculated creatinine clearance (glomerular filtration rate can also be used in place of creatinine or CrCl) \\\u003C 50 mL\u002Fmin for patients with creatinine levels \\> 1.5 × institutional ULN.\n    5. Aspartate aminotransferase (AST) or Alanine transaminase (ALT) ≥ 2.5 × ULN in the absence of hepatic metastases or ≥ 5 × ULN with hepatic metastases at screening.\n    6. Total bilirubin ≥ 1.2 × ULN are excluded unless direct bilirubin is ≤ ULN. If there is no institutional ULN, then direct bilirubin must be \\\u003C 40% of total bilirubin to be eligible (except patients with Gilbert syndrome, who must have total bilirubin \\\u003C 51.3 μmol\u002FL).\n    7. International normalized ratio or prothrombin time (PT) \\> 1.5 × ULN.\n    8. Activated partial thromboplastin time (aPTT) \\> 1.5 × ULN.\n    9. Evidence of acute infection of hepatitis B virus (HBV), (for example: positive for HBsAg, anti-HBc, IgM anti-HBc and negative for anti-HBs), hepatitis C virus (HCV) (for example: HCV antibody reactive; HCV RNA detected) and HIV.\n\n    Patients who are on stable antiviral therapy, in good clinical control (ie for HIV a viral load \\\u003C 400 copies\u002FmL and a CD4+ count of ≥ 350 cells\u002FuL) AND asymptomatic are eligible for the study\n16. Presence of active or inactive 'latent' tuberculosis.","ALL","18 Years",{"count":20,"type":21},26,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The goal of this clinical trial is to learn how roginolisib works in comparison to standard treatment in adult patients with Myelofibrosis. The main questions it aims to answer is to evaluate the safety and tolerability of roginolisib when administered in combination with ruxolitinib.",[28],"Myelofibrosis (MF)",[30],"Myelofibrosis","RECRUITING","2026-06-22",{"date":34,"type":35},"2026-06-23","ACTUAL",{"date":37,"type":35},"2025-11-17",{"date":39,"type":21},"2028-07",{"name":41,"class":42},"iOnctura","INDUSTRY",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100629072","phase-1-a-phase-1-study-of-prt12396-in-participants-with-select-myeloproliferative-neoplasms-100629072","NCT07469891","A Phase 1 Study of PRT12396 in Participants With Select Myeloproliferative Neoplasms","A Phase 1, Open-Label, Multi-Center, Safety and Efficacy Study of PRT12396 in Participants With Polycythemia Vera and Myelofibrosis","Inclusion Criteria:\n\n* Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations (including contraception requirements), and other study procedures.\n* Confirmed diagnosis of PV or MF according to WHO 2016 or revised ICC\u002FWHO 2022 criteria\n* Documented presence of a JAK2 V617 mutation\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Estimate life expectancy of ≥12 weeks per investigator assessment.\n* Negative serum or urine pregnancy test and agree to use contraception or maintain true abstinence.\n* Adequate organ function and bone marrow reserves (hematology, renal, and hepatic)\n\nExclusion Criteria:\n\n* History of another malignancy within 3 years prior to enrollment, except for malignancy considered cured with low risk of recurrence.\n* Clinically significant anemia due to nutritional deficiency or hemolytic disorders.\n* Active or uncontrolled infection requiring systemic therapy or hospitalization.\n* Any other medical or psychiatric conditions that, in the Investigator's judgment, would increase risk or interfere with study participation or interpretation of results.\n* Clinically significant or uncontrolled medical conditions, including active infection or cardiovascular disease, that would increase risk or interfere with study participation.\n* Unresolved toxicity \\> Grade 1 from prior anticancer therapy, except for alopecia or peripheral neuropathy ≤ Grade 2.\n* Pregnancy or breastfeeding\n* Known sensitivity or contraindication to any component of study, or the excipients of study treatment.\n* Prior systemic therapy for PV or MF, prior or planned allogeneic hematopoietic stem-cell transplantation, recent major surgery, prior splenectomy or prior splenic irradiation, or use of hematopoietic growth factors within protocol-defined washout periods.\n* Use of strong or moderate cytochrome P450 (CYP) 3A4 inhibitor or inducer, sensitive CYP3A substrates with narrow therapeutic range, or acid-reducing agents that cannot be discontinued prior to study treatment.\n* Participation in another interventional clinical study.",{"count":51,"type":21},100,[24],"This is a first-in-human, open-label, multi-center Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of PRT12396 in participants with high-risk polycythemia vera (PV) and myelofibrosis (MF), and to determine the maximum tolerated dose (MTD) and recommended dose(s) for expansion (RDE\\[s\\]). The study consists of a dose-escalation phase followed by a dose-expansion phase to further evaluate selected dose level(s).",[55,28,56,57,58,59],"Polycythemia Vera (PV)","Myeloproliferative Neoplasms (MPNs)","Post-Polycythemia Vera Myelofibrosis","Post-Essential Thrombocythemia Myelofibrosis","Primary Myelofibrosis (PMF)",[61,62,63,64,65,66,67,68],"High-Risk Polycythemia Vera (PV)","Intermediate-1 or Intermediate-2 Risk Primary MF","High-Risk Primary MF","Post-Polycythemia Vera MF","Post-Essential Thrombocythemia MF","PRT12396","JAK Inhibitor","Myeloproliferative Neoplasms (MPN)","2026-06-05",{"date":71,"type":35},"2026-06-09",{"date":73,"type":35},"2026-04-29",{"date":75,"type":21},"2028-04",{"name":77,"class":42},"Prelude Therapeutics",5,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":98,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":112},"100616220","phase-1-tacrolimus-targeted-immunosuppression-cessation-in-allogeneic-hct-100616220","NCT07302776","TACrolimus Targeted Immunosuppression Cessation in ALlogeneic HCT","TACTICAL: TACrolimus Targeted Immunosuppression Cessation in ALlogeneic HCT","Inclusion Criteria:\n\n* Eligible diseases:\n\n  * Acute myeloid leukemia (AML) in complete remission (CR), CR with incomplete hematologic recovery (CRi), or MLFS.\n  * Myelodysplasic syndrome (MDS) myelodysplastic syndromes eligible for alloHSCT based on IPSS-M of intermediate or higher, or IPSS-R of intermediate or higher, or refractory disease to standard growth factor or hypomethylating agent-based therapy\n  * Myelofibrosis (MF)\n  * Chronic myeloid leukemia (CML) in chronic phase with a prior history of accelerated phase or blast crisis or CML in chronic phase refractory to standard TKI therapy\n  * Chronic myelomonocytic leukemia (CMML)\n* Age ≥ 18 and ≤ 80 years at the time of enrollment.\n* Planned for first myeloablative or reduced intensity allogenic transplant using a conditioning regimen listed in Appendix B.\n* Has a related or unrelated donor available who is 8\u002F8 HLA match at HLA-A, -B, -C, and -DRB1, all typed using DNA-based high-resolution methods.\n* Estimated glomerular filtration rate (eGFR) ≥ 50 mL\u002Fminute or creatinine \\\u003C 2 mg\u002FdL.\n\nCardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA).\n\n* Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%.\n* Total bilirubin \\\u003C 2 times upper limit of normal (ULN) (patients with Gilbert's syndrome may be included once hemolysis has been excluded).\n* Karnofsky Performance Score ≥70%\n* Negative serum or urine beta-HCG test in females of childbearing potential (FCBP) within 3 weeks of enrollment.\n\nA female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).\n\n-Ability to understand and the willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Prior allogeneic HCT.\n* Planned donor lymphocyte infusion (DLI).\n* Recipient positive anti-donor HLA antibodies against a mismatched allele in the selected donor determined by either:\n\n  1. Positive crossmatch test of any titer (by complement-dependent cytotoxicity or flow cytometric testing), or\n  2. Presence of anti-donor HLA antibody to any of the following HLA loci: HLA-A, -B, -C, -DRB1, -DQB1, -DQA1, -DPB1, or -DPA1, with mean fluorescence intensity (MFI) \\>1000 by solid phase immunoassay.\n* Uncontrolled bacterial, viral, or fungal infections at time of enrollment including known, active tuberculosis infection.\n* Seropositive for HIV-1 or -2, HTLV-1 or -2, Hepatitis B sAg, and\u002For Hepatitis C antibody.\n\n  \\*History of hepatitis B or hepatitis C is permitted if viral load is undetectable per quantitative PCR and\u002For NAT.\n\nKnown allergy or hypersensitivity to planned GVHD prophylactic medications including PTCy, tacrolimus\n\n* Any uncontrolled autoimmune disease requiring active immunosuppressive treatment.\n* Concurrent malignancy diagnosed within 12 months of enrollment, except non-melanoma skin cancers or other early-stage solid tumors that have been curatively resected or treated to curative intent. Patients with history of low grade concurrent blood cancers that are controlled will be eligible.\n* Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use effective forms of birth control or abstinence for one year after transplantation.\n\n(FCBP definition: A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).\n\n-Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the recipient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results.\n\n\\* All subject files must include supporting documentation to confirm subject eligibility.","80 Years",{"count":88,"type":21},50,[24],"The purpose of this study is to test the feasibility and safety of early cessation of tacrolimus following allogeneic hematopoietic cell transplantation (HCT). Post-HCT tacrolimus is given to prevent graft-vs-host-disease (GVHD), but with the use of post-transplant cyclophosphamide (PTCy), the modern approach to GVHD prevention, GVHD rates have reduced markedly.",[92,93,94,95,28,96,97],"GVHD","Hematopoietic Cell Transplantation (HCT)","Acute Myeloid Leukemia (AML)","Myelodysplastic Syndromes","Chronic Myeloid Leukemia (CML)","Chronic Myelomonocytic Leukemia (CMML)",[99,100],"Post-Hematopoietic Cell Transplant (HCT) tacrolimus","hematopoietic cell transplantation (HCT)","NOT_YET_RECRUITING","2026-04-14",{"date":104,"type":35},"2026-04-17",{"date":106,"type":21},"2026-06",{"date":108,"type":21},"2028-02",{"name":110,"class":111},"Stanford University","OTHER",1,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":112},"100634445","phase-2-luspatercept-in-preventing-poor-erythroid-engraftment-for-hematological-malignancies-with-moderate-to-severe-myelofibrosis-100634445","NCT07539779","Luspatercept in Preventing Poor Erythroid Engraftment for Hematological Malignancies With Moderate to Severe Myelofibrosis","The Efficacy and Safety of Luspatercept in Preventing Poor Erythroid Engraftment After Allo-HSCT for Hematological Malignancies With Moderate to Severe Myelofibrosis: A Prospective, Multicenter, Randomized Controlled Study","Inclusion Criteria:\n\n* Age 18-65 years old, gender not restricted;\n* ECOG score 0-2 points;\n* Hematological malignancies with moderate to severe myelofibrosis\n* Willing to undergo the first allo-HSCT with a suitable donor\n* In a CR state before transplantation.\n\nExclusion Criteria:\n\n* Has previously undergone allo-HSCT;\n* ECOG score is 3-5;\n* Expected lifespan after transplantation is less than 30 days;\n* Has severe cardiac dysfunction, severe arrhythmia or severe pulmonary dysfunction (obstructive and\u002For restrictive ventilation disorder);\n* Has severe liver dysfunction, with liver function indicators (aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (TBIL)) more than twice the upper limit of normal;\n* Has severe renal dysfunction, with creatinine (Cr) more than twice the upper limit of normal or 24-hour creatinine clearance rate (Ccr) lower than 30 ml\u002Fmin;\n* Has severe active bleeding;\n* Patients judged by the investigator to be unsuitable for participating in this trial.","65 Years",{"count":122,"type":21},196,[25,124],"PHASE3","Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an important treatment for hematological malignancies. Poor erythroid engraftment after transplantation is a serious complication, especially in patients with moderate to severe myelofibrosis (MF). Currently, there is a lack of effective prevention strategies for poor erythroid engraftment after transplantation. Luspatercept, a novel TGF-β superfamily signaling pathway modulator, has shown potential in small-sample studies for the treatment and prevention of post-transplant anemia. Given the high proportion and poor prognosis of poor engraftment function in hematological malignancies with moderate to severe myelofibrosis after transplantation, we plan to conduct a prospective, multicenter, randomized controlled study to explore the efficacy and safety of luspatercept in preventing poor erythroid engraftment after allo-HSCT in hematological malignancies with moderate to severe myelofibrosis.",[127,128,129,28],"Luspatercept","Poor Erythroid Engraftment","Hematological Malignancies","2026-04-13",{"date":132,"type":35},"2026-04-20",{"date":134,"type":21},"2026-05-01",{"date":136,"type":21},"2030-12-31",{"name":138,"class":111},"Nanfang Hospital, Southern Medical University",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":148,"briefSummary":149,"conditions":150,"keywords":151,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":4},"100633689","phase-1-study-of-ze74-0282-for-patients-with-jak2-v617f-positive-blood-cancers-100633689","NCT07529951","Study of ZE74-0282 for Patients With JAK2 V617F Positive Blood Cancers","A Dose Finding Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of ZE74-0282 in Select JAK2 V617F Mutated Hematologic Disorders","Inclusion Criteria:\n\n1. Patient is ≥18 years of age at the time of obtaining informed consent.\n2. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n3. Patient has histological confirmation JAK2 V617F mutated hematologic diagnosis with later confirmation using ipsogen® JAK2 RGQ PCR Kit) with prior therapy or who have declined them.\n4. All AEs related to prior therapies (chemotherapy\u002Fsystemic therapies, radiation, surgery) must have resolved to Grade 1 or baseline except for:\n\n   1. Alopecia (Grade ≤2)\n   2. Sensory neuropathy (Grade ≤2)\n   3. Other AEs that have resolved to Grade ≤2 that, according to the clinical judgment of the investigator, do not constitute a safety risk to the patient.\n5. Adequate hematologic function including\n6. Organ function\u002Freserve as per the following laboratory criteria:\n\n   1. Hepatic: Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 2.5 x ULN, and total bilirubin \\\u003C 2 x ULN (except for patients with known or suspected Gilbert's syndrome and with direct bilirubin within normal range) for the local laboratory. If due to disease, higher values may be approved after discussion with medical monitor.\n   2. Renal: Adequate renal function as defined by calculated creatinine clearance \\>45 mL\u002Fmin for the local laboratory.\n7. Baseline corrected QT interval by Fredericia (QTcF) \\\u003C 470 ms. Patients with right, left, or partial bundle branch blocks or pacemaker that may confound interpretation of this reading are not excluded from this provided they lack history of primary arrhythmic events and are cleared by cardiology for enrollment in the trial.\n8. Pregnancy:\n\n   1. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test result at screening (not applicable to patients who are unable to become pregnant, including those with bilateral oophorectomy and\u002For hysterectomy). The test must be performed within 72 hours before Day 1 of treatment.\n   2. Women of non-child-bearing potential must have at least 12 continuous months of natural (spontaneous) amenorrhea and an appropriate clinical profile (e.g., age appropriate or history of vasomotor symptoms) or have had surgical sterilization (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) \\>42 days prior to screening.\n9. Contraception and Gamete Donation:\n\n   1. Male patients with a WOCBP partner must use 2 forms of acceptable contraception, including 1 barrier method, during their participation in the study and for 120 days following the last dose of the study treatment. They must also refrain from sperm donation from screening visit until 120 days following the last dose of study treatment.\n   2. Women of child-bearing potential must use 2 forms of acceptable contraception, including 1 barrier method, during their participation in the study and for 120 days following the last dose of the study treatment. They must also refrain from ova donation from screening visit until 120 days following the last dose of study treatment.\n10. Written informed consent must be obtained according to local guidelines and signed and dated by the patient prior to the performance of any study specific procedures, sampling, or analyses.\n\nExclusion Criteria:\n\n1. Clinical signs\u002Fsymptoms of leukostasis or thrombophilia require urgent therapy (phereses).\n2. Known active infection with Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C. Patients with a history of positive serology for hepatitis B or C require a negative Polymerase chain reaction (PCR) test for virus to go onto therapy.\n3. Disseminated intravascular coagulopathy with active, unmanageable bleeding or signs of thrombosis.\n4. Patients who have received an investigational agent (for any indication) \\\u003C14 days prior the first dose of ZE74-0282; an investigational agent is one for which there is no approved indication by the United States (US) FDA or by the applicable regulatory authority in the country where the study is being conducted. Additionally, the first dose of ZE74-0282 should not occur before the shorter of 28 days or a period of 5 half-lives of the investigational drug; if the half-life of the agent is unknown, patients must wait 4 weeks prior to first dose of study treatment.\n5. Systemic antineoplastic or radiotherapy \\\u003C14 days prior to the first day of ZE74-0282 administration (Hydroxyurea is allowed prior to study to control counts and may be given during study until completion of cycle 2.\n6. Female patients who are pregnant, lactating, or planning to become pregnant or initiate breastfeeding.\n7. Patients with psychological, familial, social, or geographic factors, other significant medical condition, laboratory abnormality that otherwise preclude them from giving informed consent, following the protocol, potentially hamper compliance with study treatment and follow-up or would confound the interpretation of the results of the study.\n8. Patients with the following will be excluded: uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, myocardial infarction with evidence of residual abnormalities, stroke or transient ischemic attack within 6 months prior to enrollment (Troponin (regular or high sensitivity) leak alone not included if no residual dysfunction),\n9. Patients with medical comorbidities that will preclude safety evaluation of the combination should not be enrolled.\n10. Patients with uncontrolled infection requiring parenteral therapy shall not be enrolled until infection is treated and brought under control (to minimum of requirement of oral antibiotics).\n11. Currently participating in or has planned participation in a study of another investigational agent or device.\n12. Active prior or concurrent malignancy. Such patients for whom the natural history of the malignancy or its treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational schedule are eligible for this study, if approved in writing by the sponsor. Examples of such malignancies include basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and early-stage prostate cancer undergoing watchful waiting. Patients with a completely treated prior malignancy and no evidence of disease for \\>2 years prior to the first dose of ZE74-0282 are eligible.\n13. Patient for whom MRI OR CT imaging of spleen can not be performed on the same imaging platform throughout the study",{"count":147,"type":21},60,[24],"This study will test an experimental drug called ZE74-0282 in people with certain blood disorders caused by a specific mutation called JAK2 V617F. The main goals are to find the right dose level, to see how safe and tolerable different doses are, how the drug moves through the body, and whether it shows early signs of anti-tumor activity. Participants will receive ZE74-0282 in one of several dose groups. The study is open-label, meaning both the doctor and the participant know which treatment is given. It will take place at multiple centers across different countries. Blood tests and regular check-ups will be done to monitor side effects and measure the effect on the disease.",[55,28],[152,153,154],"JAK2 V617F mutations","polycythemia vera","myelofibrosis","2026-04-08",{"date":102,"type":35},{"date":158,"type":21},"2026-05-15",{"date":160,"type":21},"2028-12-30",{"name":162,"class":42},"Eilean Therapeutics",{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":22,"phases":173,"briefSummary":175,"conditions":176,"keywords":177,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":4},"100631248","phase-4-comparing-momelotinib-and-ruxolitinib-in-people-with-untreated-myelofibrosis-and-low-blood-cell-counts-100631248","NCT07498205","Comparing Momelotinib and Ruxolitinib in People With Untreated Myelofibrosis and Low Blood Cell Counts","A Randomized Open Label Trial Comparing Momelotinib vs Dose-Adjusted Ruxolitinib For Treatment-Naive, Cytopenic Myelofibrosis","APEX-MF","Registration Step 1: Randomization\n\nInclusion Criteria:\n\n* Participants must have confirmed diagnosis of primary myelofibrosis (PMF), post-polycythemia vera (PV) MF or post-essential thrombocythemia (ET) MF as assessed by the treating physician per 2022 WHO classification, and confirmed by a bone marrow biopsy within four years.\n* Participants must have a spleen measuring ≥ 450 cm3 by MRI within 14 days prior to Step 1 registration. For participants with a medical contraindication to MRI or if MRI is unavailable, a CT scan may be performed.\n* Participants must have DIPSS risk category of Intermediate-1, Intermediate-2 or High per Dynamic International Prognostic Scoring System (DIPSS) for MF.\n* Participants must have blasts \\\u003C10% in peripheral blood within 28 days of Step 1 registration. If bone marrow biopsy performed within 28 days prior to Step 1 registration blasts must be \\\u003C10% as well.\n* Participants must have discontinued all drugs used to treat MF, including hydroxyurea, peginterferon alfa-2a, ropeginterferon alfa-2b, anagrelide or busulfan ≥ 14 days prior to Step 1 registration.\n* Participants must be ≥ 18 years old at the time of registration.\n* Participants must have Zubrod\u002FECOG Performance Status of 0-2.\n* Participants must have a complete medical history and physical exam within 28 days prior to Step 1 registration.\n* Participants must meet hematologic parameters within 28 days prior to Step 1 registration.\n* Participants must have a calculated creatinine clearance ≥ 30 mL\u002Fmin using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to Step 1 registration. For creatinine clearance formula see the tools on the CRA Workbench https:\u002F\u002Ftxwb.crab.org\u002FTXWB\u002FTools.aspx.\n* Participants must be able to take orally administered medication and comply with the oral regimen.\n* Participants with a history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at Step 1 registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to Step 1 registration.\n* Participants with a history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to Step 1 registration, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to Step 1 registration, if indicated.\n* Participants must be offered the opportunity to participate in specimen banking.\n* Participants who can complete PRO and QOL questionnaires in English or Spanish languages must agree to participate in the patient-reported outcomes and quality of life questionnaires.\n* Participants or their legally authorized representative must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and WCG IRB regulations.\n\nExclusion Criteria:\n\n* Participants must have discontinued all drugs used to treat MF, including hydroxyurea, peginterferon alfa-2a, ropeginterferon alfa-2b, anagrelide or busulfan ≥ 14 days prior to Step 1 registration.\n* Participants must not be considered eligible for hematopoietic stem cell transplantation (HSCT) or have prior HSCT for MF.\n* Participants must not have received prior JAK or ACVR1 inhibitor treatment.\n* Participants must not have received investigational therapy within 14 days prior to Step 1 registration.\n* Participants must not have had a prior splenectomy.\n* Participants must not have had splenic irradiation within 90 days prior to Step 1 registration.\n* Participants must not have received prior chemotherapy for their MF (e.g., hypomethylating agent, hypomethylating agent + venetoclax).\n* Participants must not have had major surgery within 21 days prior to Step 1 registration.\n* Participants must not have received a live vaccine within 14 days prior to Step 1 registration.\n* Participants must not have grade 2 or higher peripheral neuropathy.\n* Participants must not have clinically significant cardiac disease (New York Heart Association Class III or IV); symptomatic congestive heart failure; or unstable angina pectoris. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.\n* Participants must not have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).\n* Participants must not have history of stroke, reversible ischemic neurologic deficit, or transient ischemic attack within 90 days prior to Step 1 registration.\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Participants with curatively treated basal or squamous cell skin cancer, superficial bladder cancer, in situ cervical cancer and\u002For in situ breast cancer may be enrolled.\n* Participants must not have uncontrolled systemic fungal, bacterial, viral or other infection (defined as exhibiting ongoing signs\u002Fsymptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) as determined by the local investigator.\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen.\n\nRegistration Step 2: Optional Crossover for All Participants after Week 24 Assessment\n\nInclusion Criteria:\n\n* Participants must have met one or more of the following criteria on Registration Step 1:\n\n  1. Spleen volume decrease \\\u003C10% or spleen volume increase of any volume from baseline MRI (or CT) in response to initial treatment (momelotinib or ruxolitinib) from baseline MRI (or CT) at week 24.\n  2. ≥ 3 units of RBC transfusions during any rolling 8-week period starting at or after week 16 preceding Step 2 registration OR hemoglobin \\\u003C 8 g\u002FdL on two consecutive measurements at least 1 week apart during any rolling 8-week period starting at or after week 16 preceding Step 2 registration.\n  3. Unacceptable toxicities attributed to initial treatment (momelotinib or ruxolitinib) of grade ≥ 3 (or grade \\\u003C 3 if determined clinically significant by treating physician) as determined by treating physician.\n  4. Unable to maintain total daily ruxolitinib dose ≥ 20 mg due to cytopenias or intolerance (crossover to momelotinib only).\n* Participants must be able to safely receive the crossover drug (either momelotinib or ruxolitinib) in the opinion of the treating investigator.\n* Participants must have adequate organ and marrow function within 14 days prior to Step 2 registration.\n* Participants must have a calculated creatinine clearance ≥ 30 mL\u002Fmin using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 14 days prior to Step 2 registration. For creatinine clearance formula see the tools on the CRA Workbench https:\u002F\u002Ftxwb.crab.org\u002FTXWB\u002FTools.aspx.",{"count":172,"type":21},268,[174],"PHASE4","The purpose of this study is to compare momelotinib and ruxolitinib as treatments for myelofibrosis with low blood cell counts. Both drugs are approved by the FDA to treat myelofibrosis. The study asks which drug does a better job at shrinking the spleen.",[30,28],[30,178,179],"momelotinib","ruxolitinib","2026-04-03",{"date":182,"type":35},"2026-04-09",{"date":184,"type":21},"2026-08-08",{"date":186,"type":21},"2031-08-08",{"name":188,"class":189},"SWOG Cancer Research Network","NETWORK",{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":198,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":201,"briefSummary":202,"conditions":203,"keywords":205,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":4},"100629194","phase-2-gecacitinib-pre--during--and-post-hsct-for-patients-with-primary-or-secondary-myelofibrosis-100629194","NCT07471503","Gecacitinib Pre-, During- and Post-HSCT for Patients With Primary or Secondary Myelofibrosis","A Phase 2 Clinical Study of Gecacitinib in Peri-transplant Period of Hematopoietic Stem Cell Transplantation in Patients With Myelofibrosis (MF)","CONTINUUM-MF","Inclusion Criteria:\n\n1. Aged 18-75 years, regardless of gender;\n2. Diagnosis of primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV-MF), or post-essential thrombocythemia myelofibrosis (post-ET-MF) according to the 2022 WHO diagnostic criteria;\n3. Meeting the criteria for intermediate-risk or high-risk groups per the DIPSS-plus classification;\n4. Scheduled to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT), including transplants from HLA-matched or mismatched related or unrelated donors;\n5. ECOG performance status ≤2 and Karnofsky performance status ≥60%;\n6. Capable of understanding and signing the informed consent form, and able to comply with study and follow-up procedures.\n\nExclusion Criteria:\n\n1. Patients using other JAK inhibitors (except for Gecacitinib) at the time of screening may be enrolled if they switch to Gecacitinib treatment prior to screening.\n2. Patients who have previously undergone allogeneic hematopoietic stem cell transplantation or organ transplantation.\n3. Disease progression to accelerated or blast phase (peripheral blood or bone marrow blast percentage ≥10% at any time prior to transplantation).\n4. Presence of significant medical conditions or marked organ dysfunction that cannot be adequately controlled and may affect the completion of this study:\n\n   1. Congestive heart failure classified as New York Heart Association (NYHA) Class III-IV, or documented history of diastolic or systolic dysfunction (e.g., LVEF \\\u003C40% measured by echocardiography), or uncontrolled or unstable angina or myocardial infarction.\n   2. Uncontrolled diabetes (\\>250 mg\u002FdL or \\>13.9 mmol\u002FL).\n   3. Hypertension that cannot be reduced to the following range despite combination antihypertensive therapy (systolic blood pressure \\\u003C160 mmHg, diastolic blood pressure \\\u003C100 mmHg).\n   4. Peripheral neuropathy (≥ Grade 2 per NCI-CTC AE v5.0 criteria).\n   5. Serum creatinine \\>1.5 × ULN.\n   6. ALT or AST \\>2.5 × ULN, or DBIL or TBIL \\>2.0 × ULN.\n5. Patients with any bacterial, viral, or fungal infection not adequately controlled.\n6. HIV-positive at screening, or active hepatitis B virus infection (HBsAg-positive with HBV-DNA positivity or above the normal reference range), or HCV antibody-positive with HCV-RNA positivity.\n7. History of tuberculosis or positive interferon-gamma release assay at screening.\n8. Suspected hypersensitivity to Gecacitinib Hydrochloride, drugs of the same class, or any of their excipients.\n9. Pregnant or breastfeeding women, or patients unwilling to use effective contraception during Gecacitinib treatment and for one week after the last dose.\n10. Patients with any other comorbidities that may interfere with the study or a history of prior malignancies.\n11. Patients unable to take oral tablets.","75 Years",{"count":200,"type":21},39,[25],"The investigators evaluate the efficacy and safety of Gecacitinib in patients with myelofibrosis (MF) before, during, and after allogeneic hematopoietic stem cell transplantation (allo-HSCT).",[28,204],"HSCT",[154,204,206],"Gecacitinib","2026-03-12",{"date":209,"type":35},"2026-03-13",{"date":211,"type":21},"2026-03-16",{"date":213,"type":21},"2030-04-01",{"name":215,"class":111},"Institute of Hematology & Blood Diseases Hospital, China",{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":22,"phases":225,"briefSummary":227,"conditions":228,"keywords":229,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":112},"100625172","a-new-diagnostic-algorithm-to-non-invasively-track-fibrotic-changes-in-myeloproliferative-neoplasms-based-on-c-c-chemokine-receptor-2-detection-from-flow-cytometry-to-the-development-of-targeted-positron-emission-tomography-molecular-imaging-pre-clinical-studies-and-first-in-human-proof-of-concept-100625172","NCT07419178","A New Diagnostic Algorithm to Non-invasively Track Fibrotic Changes in Myeloproliferative Neoplasms Based on C-C Chemokine Receptor 2 Detection. From Flow Cytometry to the Development of Targeted Positron Emission Tomography Molecular Imaging. Pre-clinical Studies and First In-human Proof of Concept","GR-MPN","Inclusion Criteria:\n\n* Diagnosis of ET\u002FPV\u002FprePMF\u002FovertPMF according to the WHO 2016 criteria and of SMF according to the IWG-MRT criteria (with histopathological data).\n* Age \\>= 18 yrs\n* ECOG performance status \\\u003C=3\n\nExclusion Criteria:\n\n* Pregnancy\u002Fbreastfeeding\n* Ongoing therapy with immunomodulatory drugs (JAK-inhibitors, interferon).\n* For PET imaging, patients should be off any cytoreductive treatment for at least 3 months.\n* Antiplatelet agents are allowed",{"count":224,"type":21},265,[226],"NA","Chronic \"Philadelphia-negative\" myeloproliferative syndromes are chronic blood disorders. They include essential thrombocythemia, polycythemia vera, and myelofibrosis. Myelofibrosis may arise de novo (\"primary myelofibrosis\") or represent the evolution of essential thrombocythemia or polycythemia vera (\"secondary myelofibrosis\").\n\nThe myelofibrotic stage-characterized, as the name implies, by the presence of bone marrow fibrosis (deposition of scar-like tissue)-is generally associated with a more severe and symptomatic disease. To date, the only way to assess fibrotic progression in these disorders is bone marrow biopsy.\n\nThe aim of this project is to evaluate whether the identification, tracking, and quantification of cells expressing a specific receptor (CCR2), a selective biomarker of fibrosis, may allow early and non-invasive identification of the fibrotic stage of the disease through:\n\n* laboratory analysis on a blood sample (using flow cytometry)\n* use in PET-CT (positron emission tomography combined with computed tomography) of a tracer specific for the CCR2 receptor, capable of selectively binding to CCR2-expressing cells (⁶⁸Ga-DOTA-ECL1i).",[28],[230,231,232,233,234,235,236,237,238,239],"C-C chemokine receptor 2","Myeloproliferative neoplasms","PET","immunohystochemical assay","early detection of cancer","progression monitoring","therapy response monitoring","MRI","MRS","fluorescence","2026-02-16",{"date":242,"type":35},"2026-02-18",{"date":244,"type":35},"2023-09-05",{"date":246,"type":21},"2027-04-30",{"name":248,"class":111},"Azienda Ospedaliero-Universitaria di Parma",{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":258,"phases":4,"briefSummary":259,"conditions":260,"keywords":309,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":350},"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":257,"type":21},5000,"OBSERVATIONAL","The MPN PROGRESSion Registry is a multi-year, observational research study designed to improve understanding of myeloproliferative neoplasms (MPNs)-a group of rare, chronic blood cancers that include polycythemia vera (PV), essential thrombocythemia (ET), primary myelofibrosis (MF), pre-fibrotic primary myelofibrosis (pre-PMF), secondary myelofibrosis, myeloproliferative neoplasm-unclassifiable (MPN-U), MPN in accelerated phase (MPN-AP), and MPN in blast phase (MPN-BP), post-MPN Acute Myeloid Leukemia (AML), and MDS\u002FMPN overlap syndrome as defined above per WHO 2022 criteria, including patients originally diagnosed with one of these conditions but who have received one or more SCTs and\u002For BMTs . These conditions are characterized by abnormal blood cell production in the bone marrow and may lead to complications such as blood clots, bleeding, bone marrow fibrosis, and, in some cases, progression to acute leukemia.\n\nThe central hypothesis of the registry is that collecting and analyzing real-world, longitudinal data-including electronic health records (EHRs), laboratory values, treatments, and patient-reported outcomes (PROs)-from a diverse population of people living with MPNs will help identify patterns and predictors of disease progression, treatment response, quality of life, and long-term outcomes. These insights are intended to guide future research, inform clinical guidelines, and support improvements in patient care.\n\nThe registry is non-interventional and observational; participants do not receive investigational treatments, and all medical care continues under the supervision of their own physicians. Data collection includes EHRs, PRO surveys, patient-reported symptom and lab tracking, insurance claims, and, in the future, may include linkages with other relevant disease registries and datasets. Potential collaborations under consideration include those with the European LeukemiaNet (ELN) MPN Registry, the Mayo Clinic MPN Database, the Center for International Blood and Marrow Transplant Research (CIBMTR), the SEER Program, Harmony Alliance Foundation, and the National Cancer Database (NCDB).\n\nThe registry emphasizes the patient voice, incorporating lived experiences related to hallmark MPN symptoms such as fatigue, pruritus (itching), bone pain, night sweats, and social and emotional impacts. Participants will be followed for at least five years, with many enrolled for ten years or longer, to capture the natural history of disease and long-term outcomes. PRO surveys will be completed approximately every six months, and EHR data will be regularly reviewed to track changes in clinical status, treatment, and disease evolution.\n\nStatistical analyses will use descriptive and inferential methods to examine clinical characteristics, symptom burden, disease trajectories, and patient-centered outcomes. Planned subgroup analyses may compare differences across diagnoses, treatment approaches, demographics, or genomic factors. Analytic plans will be finalized during the course of the study and may evolve in response to emerging scientific questions.\n\nThe registry is open to adults (18 years or older) living in the United States who have been diagnosed with any of the included MPN subtypes and are willing to share health information and complete study surveys. Individuals currently enrolled in interventional clinical trials or unable to provide informed consent may be excluded. Participation is voluntary, and participants may withdraw from the study at any time without affecting their medical care.\n\nPrivacy and data security are core priorities. Participant data will be securely stored and managed in accordance with all applicable privacy laws and research regulations. No identifiable information will be shared with external parties without appropriate authorization. Oversight is provided by a Steering Committee and a Patient Engagement Advisory Committee (PEAC), ensuring rigorous scientific, ethical, and patient-centered governance.\n\nThe registry is sponsored by the MPN Research Foundation, a nonprofit organization advancing research and patient advocacy in myeloproliferative neoplasms (MPNs). Participants can contact the registry team at any time with questions and will receive periodic updates on study findings.\n\nThis study aims to address critical gaps in understanding the real-world experiences of people with MPNs-such as symptom burden over time, risk factors for progression, and how different treatments impact patient outcomes. Findings may inform clinical trial design, support biomarker discovery, and contribute to the development of updated treatment recommendations. The registry is committed to including participants from diverse backgrounds and clinical settings to ensure findings are broadly applicable across the MPN community. Summary results will be shared through scientific publications, presentations, and other dissemination efforts to advance MPN research and care globally.",[261,262,55,263,264,59,30,28,265,266,267,268,269,270,271,272,273,274,275,276,277,57,278,279,280,281,58,282,283,284,285,286,287,288,289,56,290,291,292,293,294,295,296,297,298,299,300,301,302,303,304,305,306,307,308],"Polycythemia Vera","ET (Essential Thrombocythemia)","Essential Thrombocythemia (ET)","Primary Myelofibrosis (MF)","Myelofibrosis, Primary","Myelofibrosis, Post ET","Myelofibrosis, Post PV","Myelofibrosis (PMF)","Myelofibrosis，MF","Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis","Myelofibrosis Due to and Following Polycythemia Vera","Myelofibrosis Transformation in Essential Thrombocythemia","Myelofibrosis With High Molecular Risk Mutations","MF","Secondary Myelofibrosis","Secondary Myelofibrosis in Myeloproliferative Disease","Secondary Myelofibrosis (Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis)","Post-polycythemia Vera Myelofibrosis (PPV-MF)","Post-polycythemia Vera Myelofibrosis (Post-PV MF)","Post-polycythemia Vera Myelofibrosis(Post-PV MF)","Post-PV MF","Post-essential Thrombocythemia Myelofibrosis (PET-MF)","Post-essential Thrombocythemia Myelofibrosis(Post-ET MF)","Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)","Post-ET MF","Pre-fibrotic Myelofibrosis","Myeloproliferative Disorder","Myeloproliferative Disorders","Myeloproliferative Disorders (MPD)","Myeloproliferative Neoplasm(MPN)-Associated Myelofibrosis","Myeloproliferative Neoplasm With 10% Blasts or Higher","Myeloproliferative Neoplasms","MPN","MPN (Myeloproliferative Neoplasms)","MPN-associated Myelofibrosis","Myeloproliferative Neoplasm, Unclassifiable","Myeloproliferative Neoplasm, Not Otherwise Specified","Accelerated Phase MPN","Accelerated Phase Myeloproliferative Neoplasm","Blast Phase MPN","Blast Phase Myeloproliferative Neoplasm","Thrombocythemia Myelofibrosis (PET-MF)","Thrombocythemia, Essential","Thrombocythemia, Hemorrhagic","Agnogenic Myeloid Metaplasia","Chronic Idiopathic Myelofibrosis","Idiopathic Myelofibrosis","MDS\u002FMPN Crossover Syndromes",[292,261,310,275,311,287,296,312,313,314,315,316,317,318,319,320,321,322,323,324,325,326,327,328,329,330,331,332,333,334,335,336,337,338,339,340],"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":343,"type":35},"2026-01-23",{"date":345,"type":35},"2025-09-26",{"date":347,"type":21},"2035-09-08",{"name":349,"class":111},"MPN Research Foundation",2,{"id":352,"slug":353,"hasResults":11,"nctId":354,"briefTitle":355,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":357,"targetDuration":4,"studyType":22,"phases":359,"briefSummary":360,"conditions":361,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":366,"leadSponsor":368,"locationsCount":112},"100602812","phase-1-phase-iii-clinical-trial-of-axatilimab-a-csf1r-monoclonal-antibody-in-combination-with-ruxolitinib-as-therapy-for-patients-with-myelofibrosis-mf-and-chronic-myelomonocytic-leukemia-cmml-100602812","NCT07128381","Phase I\u002FII Clinical Trial of Axatilimab, a CSF1R Monoclonal Antibody, in Combination With Ruxolitinib as Therapy for Patients With Myelofibrosis (MF) and Chronic Myelomonocytic Leukemia (CMML)","Inclusion Criteria:\n\n* Age .18 years as MF and CMML are very rare diseases in the pediatric population.\n* Diagnosis of MF by WHO or ICC and:\n\n  1. Phase 1 dose escalation (Cohort A and B): at least 1 prior therapy for MF or with suboptimal response after at least 3 months of therapy with a JAK inhibitor.\n  2. Phase 2 dose expansion:\n\n  i. Relapsed cohort (Cohort C): Patients with at least 1 prior MF therapy. or ii. JAKi-naive cohort (Cohort D): patients with newly diagnosed and treatment naive MF with intermediate .1 risk by DIPSS-plus (Appendix 2)\n* Diagnosis of CMML refractory to treatment with hydroxyurea (for patients with proliferative CMML defined as WBC.13x109\u002FL) or at least 4 cycles of treatment with hypomethylating agent, with relapse\u002Fprogression after any number of cycles of hypomethylating agent therapy or who are intolerant of treatment with either therapy. Patients may have received prior therapy with other investigational agents or cytotoxic regimens.\n* ECOG performance status ≤2\n* Adequate hepatic function with total bilirubin \\\u003C\u002F=3 x ULN, AST or A LT \\\u003C\u002F= 3xULN unless related to disease involvement.\n* Serum creatinine clearance \\>30mL\u002Fmin and no end\u002Fstage renal disease (using Cockcroft-Gault).\n* Prior hydroxyurea for control of leukocytosis or use of hematopoietic growth factors (eg, G-CSF, GM-CSF, procrit, aranesp, thrombopoietin) is allowed at any time prior to cycle 1 day 1 of therapy.\n* Patient (or patient's legally authorized representative) must have signed an informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study. Non-English speaking patients may be consented.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n\n  * Patients 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, patients should be class 2B or better.\n  * Women of child-bearing potential 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. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n    * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n    * History of hysterectomy or bilateral salpingo-oophorectomy.\n    * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n    * History of bilateral tubal ligation or another surgical sterilization procedure.\n  * Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. 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.\n  * Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients who are currently receiving treatment for a malignancy (not including basal cell carcinoma, nonmelanoma skin cancer, cervical carcinoma in situ, early stage breast cancer or localized prostate cancer treated with hormone therapy). Patients with history of other cancers should be free of disease for at least 2 years prior to the Screening Visit or not requiring active treatment at the time of enrollment.\n* Patients who are receiving any other investigational agents or with prior CSF1-R inhibitor therapy.\n* Active, uncontrolled bacterial, fungal, parasitic, or viral infection. Infections are considered controlled if appropriate therapy has been initiated and, at the time of screening, there is no evidence of infection worsening, such as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs, or radiographic findings attributable to infection.\n* Patients with evidence of active or latent tuberculosis. Prior to enrollment, patients should be evaluated for tuberculosis risk factors, and those at higher risk should be tested for latent infection. Risk factors include, but are not limited to, prior residence in or travel to countries with a high prevalence of tuberculosis, close contact with a person with active tuberculosis, and a history of active or latent tuberculosis where an adequate course of treatment cannot be confirmed.\n* Patients who have a known malabsorption syndrome or other condition that may impair absorption of study medication (e.g., gastrectomy).\n* History of acute or chronic pancreatitis.\n* Active symptomatic myositis.\n* Platelet count \\\u003C50x109\u002FL prior to enrollment and treatment initiation (for ruxolitinib combination cohorts only) except if related to either treatment for MF or CMML or treatment with cytotoxic therapy for any other reason.\n* Pregnant women are excluded from this study because axatilimab and ruxolitinib are agents 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 these agents, breastfeeding should be discontinued if the mother is treated on study. These potential risks may also apply to other agents used in this study.\n* Patients with reproductive potential who are unwilling to following contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives \\[birth control pills\\], contraceptive injections, intrauterine devices \\[IUD\\], doublebarrier method \\[spermicidal jelly or foam with condoms or diaphragm\\], contraceptive patch, or surgical sterilization) throughout the study.\n* Female patients with reproductive potential who do not have a negative urine or blood betahuman chorionic gonadotropin (beta HCG) pregnancy test at screening.\n* Patients receiving any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy within 7 days of therapy initiation.\n* Patients with history of chronic hepatitis B or C, irrespective of surface antigen or viral load detection given risk of viral reactivation with JAK inhibitor therapy.\n* Patients with history of HIV given risk of JAK inhibitor-related immune-suppression.\n* New York Heart Association (NYHA) Class III or IV congestive heart failure or LVEF \\\u003C50 by echocardiogram or multigated acquisition (MUGA) scan.\n* History of myocardial infarction or thromboembolic disease within the last 6 months or unstable\u002Funcontrolled angina pectoris or history of severe and\u002For uncontrolled ventricular arrhythmias.\n* Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.",{"count":358,"type":21},66,[24,25],"* To find the recommended dose of axatilimab given alone and in combination with ruxolitinib in patients with MF and CMML.\n* To learn if axatilimab given in combination with ruxolitinib can help to control MF and CMML.",[28,97],"2026-01-02",{"date":364,"type":35},"2026-01-05",{"date":362,"type":35},{"date":367,"type":21},"2033-07-31",{"name":369,"class":111},"M.D. Anderson Cancer Center",{"id":371,"slug":372,"hasResults":11,"nctId":373,"briefTitle":374,"officialTitle":374,"acronym":375,"eligibilityCriteria":376,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":377,"targetDuration":4,"studyType":22,"phases":379,"briefSummary":380,"conditions":381,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":112},"100557679","phase-2-methotrexate-in-myeloproliferative-neoplasms-treatmore-trial-100557679","NCT06541249","MethoTRExATE in MyelOpRolifErative Neoplasms (TREATMORE) Trial","TREATMORE","Inclusion Criteria\n\n* Be ≥18 years of age at time of signing the informed consent form (ICF)\n* Must voluntarily sign ICF and be willing and able to adhere to the study visit schedule and all protocol requirements\n* Have a pathologically confirmed diagnosis of PV, ET, PMF, post-ET-MF, or post-PV-MF as per WHO diagnostic criteria\n* Participants with MF may have low, intermediate 1, intermediate 2, or high-risk disease by Dynamic International Prognostic Scoring System (DIPSS). Participants with PV and ET with both low- and high-risk disease may be included.\n* Must have received at least 12 weeks of current MPN therapy at stable doses and have persistent clinical burden and\u002For cytologic abnormalities as defined by the following:\n\n  * Clinical burden is defined as MPN-SAF TSS \\>12 points and\u002For palpable spleen of ≥5cm\n  * Cytologic abnormalities include the following for each disease state:\n\n    * MF:\n\n      * Persistent leukocytosis as defined by WBC \\>12 x 109\u002FL\n    * PV:\n\n      * Persistent therapeutic phlebotomy dependence (\\>2 phlebotomies within 24 weeks of screening, and \\>1 phlebotomy within 16 weeks of screening, as defined in the PROUD-PV studies) for a goal HCT \\\u003C45% and\u002For\n      * Leukocytosis as defined by WBC \\>12 x 109\u002FL and\u002For\n      * Thrombocytosis defined as platelet count \\>500 x 109\u002FL\n    * ET:\n\n      * Persistent leukocytosis as defined by WBC \\>12 x 109\u002FL and\u002For\n      * Thrombocytosis defined as platelet count \\>500 x 109\u002FL\n  * Permitted concurrent MPN therapies include: aspirin, hydroxyurea, anagrelide, ropeginterferon alfa-2b, peginterferon alfa-2a, erythropoiesis-stimulating agents, phlebotomy, and\u002For ruxolitinib.\n\n    * A stable dose is defined as 12 weeks of treatment without a change in dosing\n    * Patients with myelofibrosis must be on stable dose of ruxolitinib\n* Must have adequate organ function as demonstrated by the following:\n\n  * AST, ALT \\\u003C3x upper limit of normal (ULN) and no known history of cirrhosis\n  * Total bilirubin \\\u003C3mg\u002FdL\n  * Creatinine clearance (CrCl) \\>40 mL\u002Fmin as estimated with the Cockcroft-Gault equation\n  * Baseline platelet count \\>50 x 109\u002FL for MF and \\>150 x 109\u002FL for ET\u002FPV\n  * Baseline absolute neutrophil count (ANC) \\>1000\n  * Peripheral blood blast count \\\u003C10%\n* ECOG performance status ≤2\n* Life expectancy of at least six months\n* Female participants of childbearing potential must have a negative serum pregnancy test at screening and Cycle 1 Day 1 and must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\n\n  * Recommended methods of birth control are:\n\n    * The consistent use of an approved hormonal contraception (birth control pill\u002Fpatches, rings), an intrauterine device (IUD), contraceptive injection (Depo-Provera), double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), sexual abstinence (no sexual intercourse), or sterilization\n  * A woman of childbearing potential is any woman (regardless of sexual orientation, having undergone a tubal litigation, or remaining celibate by choice) who meets the following criteria:\n\n    * Has not undergone a hysterectomy or bilateral oophorectomy; or\n    * Has not been naturally postmenopausal for at least 12 consecutive months\n* Male participants must agree to use an adequate method of contraception and must not father a child or donate sperm starting with the first dose of study therapy through 120 days after the last dose of study therapy\n\nExclusion Criteria\n\n* Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment\n* Prescribed MTX for another indication\n* History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months\n* Have other invasive malignancies within the last 3 years, except non-melanoma skin cancer and localized, cured prostate and cervical cancer\n* Have moderate or severe cardiovascular disease as defined by the following:\n\n  * Have cardiac disease, including a myocardial infarction within 6 months prior to study entry, unstable angina pectoris, New York Heart Association Class III\u002FIV congestive heart failure, or uncontrolled hypertension\n  * Have documented major ECG abnormalities (not responding to medical treatments)\n* Be an organ transplant recipient other than bone marrow transplant\n* Presence of active serious infection\n* Have a known history B, or untreated hepatitis C infection\n* Have a known history of pulmonary fibrosis, interstitial pneumonitis\n* Have a known history of chronic pericardial effusions, pleural effusions, or ascites\n* Have a known history of cirrhosis, or current heavy alcohol consumption\n* Have impairment of gastrointestinal function or gastrointestinal disease that could significantly alter the absorption of MTX, including any unresolved nausea, vomiting, or diarrhea \\> CTCAE v5.0 grade 1\n* Have known history of tuberculosis or severe fungal infection\n* Is receiving specific concomitant medications that are contraindicated with MTX.\n* Women who are pregnant or lactating, or plan to become pregnant during trial period\n* Have any serious, unstable medical or psychiatric condition that would prevent (as judged by the Investigator) the participant from signing the informed consent form or any condition, including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he\u002Fshe were to participate in the study or confounds the ability to interpret data from the study\n* Is or has an immediate family member (e.g., spouse, parent\u002Flegal guardian, sibling, or child) who is investigational site or sponsor staff directly involved with this trial, unless prospective IRB approval (by chair or designee) is given allowing exception to this criterion for a specific participant",{"count":378,"type":21},54,[25],"Low-dose MTX is a widely used, inexpensive, and safe therapy used for decades and is well tolerated by patients with rheumatologic diseases. Recently, it was identified as a type 2 JAK inhibitor. If MTX proves to be safe and tolerable with a signal of clinical activity, this could have a significant benefit to patients with MPNs. Beyond the potential benefit of adding a type 2 JAK inhibitor to current therapy, this could signal the need to study MTX in MPNs further as a monotherapy. Discovering MTX as safe and clinically effective in MPNs could be profound on both a public health and global health scale for patients who are uninsured and cannot afford more expensive novel JAK inhibitors, or for those in countries where JAK inhibitors are not available. Accordingly, the research team deems it reasonable and prudent to assess the safety and efficacy of MTX in addition to current therapy for patients with MPN. The research team will evaluate patients for spleen responses, symptom responses, and cytologic responses. Correlative data will evaluate pharmacokinetic and disease modifying activity of MTX in MPNs to inform future clinical trials.",[55,263,28],"2025-12-14",{"date":384,"type":35},"2025-12-17",{"date":386,"type":35},"2024-10-02",{"date":388,"type":21},"2027-12",{"name":390,"class":111},"Icahn School of Medicine at Mount Sinai",{"id":392,"slug":393,"hasResults":11,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":258,"phases":4,"briefSummary":400,"conditions":401,"keywords":402,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":410,"leadSponsor":412,"locationsCount":4},"100612132","momelotinib-effectiveness-in-myelofibrosis-100612132","NCT07249606","Momelotinib Effectiveness in Myelofibrosis","Real-world Observation of Momelotinib Effectiveness in Myelofibrosis (ROME)","Inclusion Criteria:\n\n1. Patients aged 18 years or older.\n2. Patients diagnosed with primary or post-polycythemia vera\u002Fpost-essential thrombocythemia myelofibrosis start treatment with MMB according to clinical practice from AIFA authorization.\n3. Patients with palpable splenomegaly at baseline of momelotinib treatment.\n4. Informed consent signed, if applicable.\n\nExclusion Criteria:\n\n1. Diagnosis of MPN, unclassifiable, myelodysplastic\u002Fmyeloproliferative neoplasms, myelodysplastic syndromes, essential thrombocythemia, polycythemia vera.\n2. Accelerated\u002Fblast phase of MF.\n3. Patients with platelets \\\u003C20 x10(9)\u002FL at baseline of MMB treatment.\n4. Patients JAK inhibitors-exposed for other diseases apart from MF.",{"count":399,"type":21},93,"Observational study aimed at evaluating the use of momelotinib in patients with primary or post polycythemia vera (PV) or post essential thrombocythemia myelofibrosis (post-ET MF) in a real-world setting.",[28],[30,178,403,404,405],"real-world","post polycythemia","post essential thrombocythemia","2025-11-18",{"date":408,"type":35},"2025-11-25",{"date":362,"type":21},{"date":411,"type":21},"2028-04-02",{"name":413,"class":111},"Gruppo Italiano Malattie EMatologiche dell'Adulto"]