[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-myelofibrosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-myelofibrosis":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,45,70,97,123,148,177,201,229,248,269,294,327,354,378,400,424,445,479,500,527,553],{"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":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100591168","research-platform-myelofibrosis-and-anemia-100591168",false,"NCT06976918","Research Platform Myelofibrosis and Anemia","Clinical Research Platform on Treatment, Quality of Life and Outcome of Patients With Primary and Secondary Myelofibrosis and Anemia Who Are JAK Inhibitor Treatment-naïve or JAK Inhibitor Treatment-experienced (RHODOLITE)","RHODOLITE","Inclusion Criteria:\n\n* Confirmed diagnosis of primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) (Note: diagnosis according to WHO-2017, ICC-2022 or WHO-2022 or IWG-MRT criteria, respectively).\n* Diagnosis of anemia at the time of enrollment as per individual, clinical assessment by the local physician.\n* Start of first or subsequent systemic treatment for MF.\n* Informed consent and registration for the GSG-MPN Bioregistry.\n* Willingness and capability to participate in PRO assessment.\n* Signed and dated informed consent form for RHODOLITE at the latest six weeks after start of the respective systemic MF treatment.\n\nExclusion Criteria:\n\n* No systemic therapy for diagnosed primary or secondary MF.\n* Planned allogenic stem cell transplantation (allo-SCT) or active participation in an interventional clinical trial.","ALL","18 Years",{"count":20,"type":21},200,"ESTIMATED","OBSERVATIONAL","The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study, a tumor research platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease and to collect patient-reported outcomes for patients with primary and secondary myelofibrosis and anemia in Germany.",[25,26,27,28,29,30,31],"Primary Myelofibrosis","Secondary Myelofibrosis","Post-polycythemia Vera Myelofibrosis","Post-essential Thrombocythemia Myelofibrosis","Anemia","Myelofibrosis; Anemia","Myelofibrosis","RECRUITING","2026-06-03",{"date":35,"type":36},"2026-06-05","ACTUAL",{"date":38,"type":36},"2026-02-19",{"date":40,"type":21},"2031-09",{"name":42,"class":43},"iOMEDICO AG","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":44},"100541226","phase-1-open-label-phase-12-study-of-tasquinimod-in-patients-with-primary-myelofibrosis-pmf-post-polycythemia-vera-myelofibrosis-post-pv-mf-or-post-essential-thrombocytosis-myelofibrosis-post-et-mf-100541226","NCT06327100","Open Label Phase 1\u002F2 Study of Tasquinimod in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), or Post-Essential Thrombocytosis Myelofibrosis (Post-ET MF)","Inclusion Criteria:\n\nParticipants eligible for inclusion in this study have to meet the following criteria:\n\nMyelofibrosis MF Monotherapy:\n\nParticipants who are not candidates for, intolerant of, or relapsed\u002Frefractory to approved JAKi (ruxolitinib and \u002F or fedratinib \u002F pacritinib) or when further benefit from therapy is not anticipated per investigator. Participants not eligible for JAKi therapy irrespectively of previous treatments. Prior JAKi therapy is not required.\n\nMyelofibrosis Ruxolitinib Combination MF participants treated with Ruxolitinib for at least 3 months on a stable, uninterrupted dose for at least 2 months prior to study enrollment AND have suboptimal response (palpable spleen of ≥5 cm, or total symptoms score of ≥10) or progressive anemia\u002Fthrombocytopenia\u002Fneutropenia.\n\nAND all the below criteria in both cohorts:\n\n* Must be diagnosed with treatment requiring PMF or post ET\u002FPV MF diagnosed according to the 2016 World Health Organization with intermediate -1, intermediate -2 or high-risk disease according to the DIPSS prognostic scoring system, or if with low risk disease then with symptomatic splenomegaly that is ≥ 5 cm below left costal margin by physical exam.\n* Peripheral or bone marrow blasts must be \\\u003C 10%\n* Participants must provide written informed consent.\n* Age 18 years or older. Because no dosing or adverse event data are currently available on the use of tasquinimod as monotherapy or in combination with ruxolitinib in patients \\\u003C18 years of age, children are excluded from this study.\n* Willing and able to comply with scheduled visits, treatment plan and laboratory tests.\n* Participant is able to swallow and retain oral medication.\n* ECOG performance status 0-2.\n* Required baseline laboratory status:\n\n  * Absolute neutrophil count (ANC) ≥ 1.0 x 109\u002FL (1000\u002Fmm3)\n  * Serum direct bilirubin ≤ 1.0 x ULN (upper limit of normal)\n  * AST (SGOT) or ALT (SGPT) \\[if both measured, then this applies to both measurements\\] ≤ 2.5 x ULN, except for participants with MF involvement of the liver who must have levels ≤ 5 x ULN\n  * Glomerular Filtration Rate (GFR) of ≥ 30 ml\u002Fmin based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation using serum or plasma creatinine or cystatin-C.\n* Treatment-related toxicities from prior therapies must have resolved to Grade ≤ 1.\n* At least 2 weeks from prior investigational MF-directed treatment (till the start of study drug). This excludes concurrent ruxolitinib which is allowed in combination cohort. Hydroxyurea is allowed as standard cytoreductive therapy up until one day prior to initiation of therapy with tasquinimod. No other standard of care therapy for MF is allowed (as specified in the exclusion criteria)\n* For women of childbearing potential, a documented negative serum or urine pregnancy test within 14 days prior to the administration of study drug.\n* The effects of tasquinimod on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female participants, 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* Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of tasquinimod administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\nParticipants eligible for this study must not meet any of the following criteria:\n\n* Any concurrent severe and\u002For uncontrolled medical conditions that could increase the participant's risk for toxicity while in the study or that could confound discrimination between disease- and study treatment-related toxicities.\n* Impaired cardiac function or clinically significant cardiac diseases, including any of the following:\n\n  * History or presence of ventricular tachyarrhythmia.\n  * Presence of unstable atrial fibrillation (ventricular response \\> 100 bpm); Participants with stable atrial fibrillation are eligible, provided they do not meet any of the other cardiac exclusion criteria.\n  * Clinically significant resting bradycardia (\\\u003C 50 bpm).\n  * Angina pectoris or acute myocardial infarction ≤ 3 months prior to starting study drug.\n  * Other clinically significant heart disease (e.g., symptomatic congestive heart failure; uncontrolled arrhythmia or hypertension; history of labile hypertension or poor compliance with an antihypertensive regimen).\n* Participants who are currently receiving chronic (\\> 14 days) treatment with corticosteroids at a dose ≥ 10 mg of prednisone (or its glucocorticoid equivalent) per day, or any other chronic immunosuppressive treatment that cannot be discontinued prior to starting study drug.\n* Treatment with chemotherapy (except hydroxyurea within 1 day prior to study treatment), immunomodulatory drug therapy (e.g. thalidomide, interferon-alpha), platelet-reducing therapy (e.g. anagrelide), immunosuppressive therapy, and erythropoetin use within 28 days prior to study treatment\n* Treatment with experimental therapy within the past 2 weeks or 5 half-lives, whichever is shorter\n* Treatment with tasquinimod at any time\n* Participants with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of tasquinimod as per physician opinion\n* Participants with known or active (acute and chronic) Hepatitis A, B, or C; and Hepatitis B and C carriers, HIV. Participants are excluded regardless of detectability of viral load (lack of safety data).\n* Participants with clinically significant bacterial, fungal, parasitic or viral infection which require therapy\n* History of pancreatitis\n* History of malabsorption or other condition that would interfere with absorption of study drugs (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection)\n* Systemic treatment within 14 days prior to the initiation of study treatment with any of the following moderate or strong inhibitor, or moderate or strong inducer of cytochrome P-3A4 (CYP3A4): imidazoles (e.g. ketoconazole), protease inhibitors (e.g. ritonavir), macrolides (e.g. erythromycin), rifampicin, rifabutin, phenytoin, carbamazepine, St. John's wort.\n* Need for ongoing therapy with any of the following drug substances of narrow therapeutic range that are metabolized mainly by CYP3A4: alfentanil, fentanyl, quinidine, astemizole, terfenadine, sirolimus, tacrolimus, cyclosporine, cisapride, and ergotamine\n* Need for ongoing therapy with any of the following drug substances of narrow therapeutic range metabolized mainly by CYP1A2: duloxetine, palonosetron, theophylline, tizanidine, and ondansetron.\n* Need for ongoing therapy with any of the following drug substances of narrow therapeutic range metabolized mainly by CYP2D6: Dosulepin, Flecainide, Sotalol, Pimozide, Procainamide, Clonidine, Desipramine, Clomipramine, Amitriptyline, Imipramine, Nortriptyline, Trimipramine, Amoxapine, Dronedarone, Phenytoin\n* Ongoing treatment with warfarin, unless the INR is \\\u003C=3.0.\n* Known hypersensitivity to tasquinimod or any excipients in the study treatments\n* Any other condition that would, in the Investigator's judgment, contraindicate subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures\n* Prior inclusion in this study\n* Pregnant women are excluded from this study because tasquinimod is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with tasquinimod, breastfeeding should be discontinued if the mother is treated with tasquinimod. These potential risks may also apply to other agents used in this study.",{"count":52,"type":21},33,"INTERVENTIONAL",[55,56],"PHASE1","PHASE2","To learn if tasquinimod either alone or in combination with ruxolitinib can help to control PMF, post-PV MF, or post-ET MF.",[25,27,59],"Post-Essential Thrombocytosis Myelofibrosis","2026-05-21",{"date":62,"type":36},"2026-05-26",{"date":64,"type":36},"2024-08-01",{"date":66,"type":21},"2031-05-01",{"name":68,"class":69},"M.D. Anderson Cancer Center","OTHER",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":53,"phases":79,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"100463861","phase-1-study-of-disc-0974-rally-mf-in-participants-with-myelofibrosis-or-myelodysplastic-syndrome-and-anemia-100463861","NCT05320198","Study of DISC-0974 (RALLY-MF) in Participants With Myelofibrosis or Myelodysplastic Syndrome and Anemia","RALLY-MF: A Phase 1b\u002F2 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of DISC-0974 in Participants With Myelofibrosis or Myelodysplastic Syndrome and Anemia","Inclusion Criteria for Participants with MF and Anemia\n\nParticipants are eligible for the study if all of the following criteria apply:\n\n1. Age 18 years or older at the time of signing the informed consent form (ICF).\n2. For Phase 1b: DIPSS score of 3 to 4 (intermediate 2 risk) or ≥5 (high-risk) primary MF, post PV MF, and\u002For post ET MF, as confirmed in the most recent local bone marrow biopsy report, according to WHO 2016 criteria.55\n\n   For Phase 2: In addition to the criteria above, DIPSS score of ≥2 (intermediate 1 risk) may also be included.\n3. Washout of at least 28 days prior to Screening of the following treatments:\n\n   1. Androgens\n   2. EPO\n   3. Cladribine\n   4. Immunomodulators (lenalidomide, thalidomide)\n   5. Luspatercept\u002Fsotatercept\n   6. Systemic corticosteroids are permitted for non-hematological conditions if stable or decreasing dose for ≥28 days prior to Screening and receiving an equivalent to ≤10 mg prednisone for the 28 days immediately prior to Screening.\n\n   Screening can begin before the 28 day washout is completed, but the washout period must be completed prior to collection of Screening blood samples.\n4. Anemia:\n\n   For Phase 1b: Hgb \\\u003C10 g\u002FdL on ≥3 assessments over 84 days prior to Screening, without RBC transfusion, or Hgb \\\u003C10 g\u002FdL and receiving RBC transfusions periodically but not meeting criteria for TD participant as defined for the TD Cohort (see Section 6.3). The baseline Hgb value for these participants is the lowest Hgb level during the 84 days prior to Screening, or RBC transfusion dependence, defined as an RBC transfusion frequency of 6 units PRBC over the 84 days immediately prior to Screening There must not be any consecutive 42 day period without an RBC transfusion in the 84 day period, and the last transfusion must be within 28 days prior to Screening.\n\n   For Phase 2:\n\n   TD high transfusion burden cohort: RBC transfusion dependence, defined as an RBC transfusion requirement of 3 to 12 PRBC units over the 84 days immediately prior to Screening TD low transfusion burden cohort: RBC transfusion dependence, defined as an RBC transfusion requirement of 1 to 2 PRBC units over the 84 days immediately prior to Screening nTD cohort: Non-transfusion dependence, baseline Hgb \\\u003C10 g\u002FdL as defined on ≥3 assessments over 84 days prior to Screening, without RBC transfusion\n5. Stable dosing of MF-directed therapy:\n\n   1. Hydroxyurea, or, if taking any other treatment for MF, stable for at least 28 days prior to Screening.\n   2. Interferon alpha stable dosing for at least 12 weeks prior to Screening.\n   3. JAK inhibitors require 12 weeks of stable dosing prior to Screening. For the TD high, TD low, and nTD cohorts, JAK inhibitors allowed include momelotinib, pacritinib, fedratinib, and ruxolitinib.\n   4. If the participant discontinues JAK inhibitor (including momelotinib\u002Fpacritinib\u002Fruxolitinib\u002Ffedratinib) and\u002For hydroxyurea prior to Screening, a 60-day washout period is required.\n6. Eastern Cooperative Oncology Group (ECOG) performance score ≤2.\n7. Infusion of hematopoietic stem cell transplant not anticipated within 8 months after Screening.\n8. TSAT \\\u003C75% (local lab acceptable).\n9. Liver iron concentration by MRI \\\u003C7 mg\u002Fg dry weight within 3 months of eligibility confirmation by central review. Required for TD high participants only.\n10. Serum ferritin ≥50 µg\u002FL at Screening.\n11. Platelet count ≥25,000\u002FµL and \\\u003C1,000,000\u002FµL; neutrophils ≥1,000\u002FµL; and total white blood cell (WBC) count \\\u003C50,000\u002FµL at Screening.\n12. Estimated glomerular filtration rate (eGFR) ≥30 mL\u002Fmin\u002F1.73 m2 by the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) formula.\n13. Aspartate aminotransferase (AST) and ALT \\\u003C3x upper limit of normal (ULN) at Screening.\n14. Direct bilirubin \\\u003C2x ULN at Screening. Higher levels are acceptable if these can be attributed by the Investigator to ineffective erythropoiesis or Gilbert's syndrome, with approval from Sponsor.\n15. If male with female sexual partner(s) of childbearing potential, agrees to use 1 of the following highly effective methods of contraception during the study and for at least 8 weeks after the last study drug dose:\n\n    1. Stable hormonal contraceptive (≥3 months; female partner)\n    2. Intrauterine device in place for at least 3 months (female partner)\n    3. Surgically sterile by hysterectomy, bilateral oophorectomy, or bilateral tubal ligation (female partner)\n    4. Confirmed successful vasectomy\n16. If female, then EITHER postmenopausal (defined as 12 months of spontaneous amenorrhea, 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels \\>40 mIU\u002Fml, or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy), surgically sterile, OR agreeable to use 1 of the following highly effective contraception methods (listed below) on Day 1 (or earlier) and for at least 8 weeks after the last dose of study drug:\n\n    1. Stable hormonal contraceptive (≥3 months)\n    2. Intrauterine device in place for at least 3 months\n    3. Tubal ligation or single male partner with vasectomy\n17. Negative urine pregnancy test (females of childbearing potential) at Screening (Days 28 to 2).\n18. Able to understand the study aims, procedures, and requirements, and provide written informed consent.\n19. Able to comply with all study procedures.\n\nInclusion Criteria for Exploratory Cohort of Participants with MDS and Anemia\n\nParticipants are eligible for the MDS exploratory cohort if all of the following criteria apply:\n\n1. Age 18 years or older at the time of signing the ICF.\n2. Molecular International Prognostic Scoring System (IPSS-M) classification of very low, low, or intermediate (ie, lower risk) MDS-ringed sideroblasts (RS) negative, MDS\u002FMPN with ringed sideroblasts and thrombocytosis (RS-T), Chronic Myelomonocytic Leukemia (CMML), Atypical Chronic Myeloid Leukemia (aCML), or Myelodysplastic\u002FMyeloproliferative Neoplasms, Unclassifiable (MDS\u002FMPN-U) as confirmed in the most recent local bone marrow biopsy report according to WHO criteria.\n3. Washout of at least 28 days is required for prior anemia\u002Fneutropenia-directed therapies, including:\n\n   1. Androgens\n   2. EPO-stimulating agents\n   3. Luspatercept\n   4. Sotatercept (ACE-011)\n   5. Imetelstat\n   6. Granulocyte colony-stimulating factor (G-CSF) OR granulocyte-macrophage CSF (GM-CSF)\n   7. Systemic corticosteroids (except for participants on a stable or decreasing dose for ≥28 days prior to randomization for non-hematological conditions and receiving an equivalent to ≤10 mg prednisone for the 28 days immediately prior to Screening) Screening can begin before the 28-day washout is completed, but the washout period must be completed prior to collection of Screening blood samples.\n4. Anemia:\n\n   1. Baseline Hgb of \\\u003C10 g\u002FdL on ≥3 assessments over 84 days prior to Screening, without RBC transfusion, or Hgb \\\u003C10 g\u002FdL and receiving RBC transfusions periodically during the 84 days prior to Screening\n   2. Medical history of ≤24 units of PRBC for MDS and anemia\n5. ECOG performance score ≤2\n6. Infusion of hematopoietic stem cell transplant not anticipated within 8 months after Screening\n7. TSAT \\\u003C75% (local lab acceptable)\n8. Liver iron concentration by MRI \\\u003C7 mg\u002Fg dry weight within 3 months of eligibility confirmation by central review\n9. Serum ferritin ≥50 μg\u002FL at Screening\n10. Platelet count ≥25,000\u002FμL and \\\u003C1,000,000\u002FμL, and total WBC count \\\u003C50,000\u002FμL at Screening or otherwise approved by Sponsor\n11. eGFR ≥30 mL\u002Fmin\u002F1.73 m2 by the CKD-EPI formula\n12. AST and ALT \\\u003C3x ULN at Screening\n13. Direct bilirubin \\\u003C2x ULN at Screening. Higher levels are acceptable if these can be attributed by the Investigator to ineffective erythropoiesis.\n14. If male with female sexual partner(s) of childbearing potential, agrees to use 1 of the following highly effective methods of contraception during the study and for at least 8 weeks after the last study drug dose:\n\n    1. Stable hormonal contraceptive (≥3 months; female partner)\n    2. Intrauterine device in place for at least 3 months (female partner)\n    3. Surgically sterile hysterectomy, bilateral oophorectomy, or bilateral tubal ligation (female partner)\n    4. Confirmed successful vasectomy\n15. If female, then EITHER postmenopausal (defined as 12 months of spontaneous amenorrhea, 6 months of spontaneous amenorrhea with serum FSH levels \\>40 mIU\u002Fml, or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy), surgically sterile, OR agreeable to use 1 of the following highly effective contraception methods (listed below) on Day 1 (or earlier) and for at least 8 weeks after the last dose of study drug:\n\n    1. Stable hormonal contraceptive (≥3 months)\n    2. Intrauterine device in place for at least 3 months\n    3. Tubal ligation or single male partner with vasectomy\n16. Negative urine pregnancy test (females of childbearing potential) at Screening (Days 28 to 2).\n17. Able to understand the study aims, procedures, and requirements, and provide written informed consent.\n18. Able to comply with all study procedures.\n\nExclusion Criteria Exclusion Criteria for Participants with MF and Anemia\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nMedical History, Participants with MF and Anemia\n\n1. Hereditary hemochromatosis\n2. Hemoglobinopathy or intrinsic RBC defect associated with anemia\n3. Total splenectomy\n4. Hematopoietic cell transplant within the past 2 years or graft vs host disease requiring immunosuppression\n5. Current anemia from iron deficiency, vitamin B12 or folate deficiency, infection, or bleeding\n6. Active immune-mediated hemolytic anemia\n7. Symptomatic bleeding, unrelated to surgery, in a critical area or organ and\u002For bleeding causing a decrease in Hgb of ≥2 g\u002FdL or leading to transfusion of ≥2 units of RBCs in the 6 months prior to Screening\n8. Major surgery within 8 weeks prior to Screening or incomplete recovery from any previous surgery\n9. Malignancy with the past 3 years, other than primary MF, post ET MF, or post PV MF. The following history or concurrent conditions are allowed:\n\n   1. basal or squamous cell carcinoma\n   2. carcinoma in situ of the cervix or the breast\n   3. histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis \\[TNM\\] clinical staging system) A history of completed treatment (medical or surgical) of stage 1-2 cancers may be permitted with prior Sponsor agreement\n10. Stroke, deep vein thrombosis, or pulmonary or arterial embolism within 3 months prior to Screening\n11. Known allergic reaction to any study drug excipient\n12. A history of anti-drug antibody formation\n13. Inadequately controlled heart disease (New York Heart Association Classification 3 or 4) and\u002For known to have left ventricular ejection fraction \\\u003C35%\n14. Hepatitis B or C, or human immunodeficiency virus (HIV) with detectable viral load\n15. Uncontrolled fungal, bacterial, or viral infection (ongoing signs\u002Fsymptoms related to the infection, without improvement despite appropriate treatment)\n\n    Treatment History, Medical History, Participants with MF and Anemia\n16. Iron chelation therapy in the 28 days prior to Screening\n17. Change in anticoagulant therapy regimen within 8 weeks prior to Screening\n\n    Laboratory Exclusions, Medical History, Participants with MF and Anemia\n18. Peripheral blood myeloblasts ≥10% of WBC differential at most recent evaluation prior to Screening\n19. Positive direct antiglobulin test in conjunction with a reactive RBC eluate at Screening\n\n    Miscellaneous, Medical History, Participants with MF and Anemia\n20. Pregnant or lactating\n21. Condition or concomitant medication that would confound the ability to interpret study data\n22. Other medical or psychiatric condition or laboratory finding not specifically noted above that, in the judgment of the Investigator or Sponsor, would put the participant at unacceptable risk or otherwise preclude the participant from participating in the study\n23. Participation in any other clinical protocol or investigational study that involves administration of experimental therapy and\u002For therapeutic devices within 30 days prior to Screening\n\nExclusion Criteria for Exploratory Cohort of Participants with MDS and Anemia\n\nParticipants are excluded from the MDS exploratory cohort if any of the following criteria apply:\n\nMedical History, Participants with MDS and Anemia\n\n1. Secondary MDS, ie, MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and\u002For radiation from other diseases\n2. Peripheral blasts ≥5%\n3. Prior treatment with hypomethylating agent or other acute myeloid leukemia (AML)-like combination chemotherapy\n4. Prior treatment with \\>3 anemia-directed therapies (unless otherwise approved by Sponsor) including:\n\n   1. Luspatercept\n   2. Sotatercept (ACE-011)\n   3. EPO-stimulating agent\n   4. Imetelstat\n5. Hereditary hemochromatosis\n6. Hemoglobinopathy or intrinsic RBC defect associated with anemia\n7. Total splenectomy\n8. Hematopoietic cell transplant within the past 10 years\n9. Current anemia from iron deficiency, vitamin B12 or folate deficiency, infection, or bleeding\n10. Active immune-mediated hemolytic anemia\n11. Symptomatic bleeding, unrelated to surgery, in a critical area or organ and\u002For bleeding causing a decrease in Hgb of ≥2 g\u002FdL or leading to transfusion of ≥2 units of RBCs in the 6 months prior to Screening\n12. Major surgery within 8 weeks prior to Screening or incomplete recovery from any previous surgery\n13. Malignancy within the past 3 years, other than MDS or MDS\u002FMPN without excess blasts. The following history or concurrent conditions are allowed:\n\n    1. basal or squamous cell carcinoma\n    2. carcinoma in situ of the cervix or the breast\n    3. histologic finding of prostate cancer (T1a or T1b using the TNM clinical staging system) A history of completed treatment (medical or surgical) of stage 1-2 cancers may be permitted with prior Sponsor agreement\n14. Stroke, deep vein thrombosis, or pulmonary or arterial embolism within 6 months prior to Screening\n15. Known allergic reaction to any study drug excipient\n16. A history of antidrug antibody formation\n17. Inadequately controlled heart disease (New York Heart Association Classification 3 or 4) and\u002For known to have left ventricular ejection fraction \\\u003C35%\n18. Active hepatitis B or C, or HIV with detectable viral load\n19. Uncontrolled fungal, bacterial, or viral infection (ongoing signs\u002Fsymptoms related to the infection, without improvement despite appropriate treatment)\n\n    Treatment History, Participants with MDS and Anemia\n20. Iron chelation therapy in the 28 days prior to Screening\n21. Change in anticoagulant therapy regimen within 8 weeks prior to Screening\n\n    Laboratory Exclusions, Participants with MDS and Anemia\n22. Positive direct antiglobulin test in conjunction with a reactive RBC eluate at Screening\n\n    Miscellaneous, Participants with MDS and Anemia\n23. Pregnant or lactating\n24. Condition or concomitant medication that would confound the ability to interpret study data\n25. Other medical or psychiatric condition or laboratory finding not specifically noted above that, in the judgment of the Investigator or Sponsor, would put the participant at unacceptable risk or otherwise preclude the participant from participating in the study\n26. Participation in any other clinical protocol or investigational study that involves administration of experimental therapy and\u002For therapeutic devices within 30 days prior to Screening",{"count":78,"type":21},150,[55,56],"This phase 1b\u002F2a open-label study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of DISC-0974 as well as categorize the effects on anemia response in subjects with myelofibrosis or myelodysplastic syndrome and anemia.",[30,29,31,82,25,28,83],"Myelofibrosis Due to and Following Polycythemia Vera","Myelodysplastic Syndromes",[85,86],"Myeloproliferative Neoplasm","Myeloproliferative Disorders","2026-05-12",{"date":89,"type":36},"2026-05-13",{"date":91,"type":36},"2022-06-06",{"date":93,"type":21},"2026-09",{"name":95,"class":43},"Disc Medicine, Inc",25,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":53,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"100542510","phase-1-a-phase-1-study-of-aj1-11095-in-patients-with-primary-myelofibrosis-pmf-post-polycythemia-vera-myelofibrosis-ppv-mf-or-post-essential-thrombocythemia-myelofibrosis-pet-mf-who-have-been-failed-by-a-type-i-jak2-inhibitor-jak2i-100542510","NCT06343805","A Phase 1 Study of AJ1-11095 in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed by a Type I JAK2 Inhibitor (JAK2i)","A Multicenter, Open-Label, Phase 1 Study of AJ1-11095 Administered as Oral Monotherapy in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed by a Type I JAK2 Inhibitor (JAK2i)","Inclusion Criteria:\n\n1. 18 years of age or older.\n2. Diagnosis of PMF, post-PV MF, or post-ET MF.\n3. DIPSS Intermediate-2 or High-risk MF with ≤10% blasts, regardless of JAK2 mutation status.\n4. Estimated spleen volume ≥450cm3.\n5. MFSAF v.4.0 TSS ≥10, or at least 2 of 7 MFSAF-assessed symptoms with scores ≥3.\n6. ECOG PS of 0, 1, 2, or 3.\n7. Prior therapy with at least 1 type I JAK2 inhibitor, and either failed to achieve a response or relapsed after achieving a response.\n8. ANC ≥1.0×10\\^9\u002FL.\n9. Platelet count ≥75×10\\^9\u002FL.\n10. eGFR ≥45 mL\u002Fmin\u002F1.73m2.\n11. Serum total bilirubin ≤2.0 × upper limit of normal (ULN).\n12. AST and ALT ≤3.0 × ULN.\n13. QTcF ≤480 msec.\n\nExclusion Criteria:\n\n1. Prior splenectomy.\n2. Splenic irradiation within 3 months prior to first dose of study drug.\n3. Ongoing use of systemic corticosteroids at dose equivalent to \\>10mg\u002Fday of prednisone.\n4. Uncontrolled intercurrent illness such as an acute infection.\n5. Chronic active or acute hepatitis B or C infection.\n6. Chemotherapy in the previous 4 weeks prior to first dose of study drug (Hydrea is permitted until 5 days before starting protocol therapy).\n7. Use of a Type I JAK2 inhibitor must have been discontinued for at least 5 days or 5 half-lives prior to dosing (whichever is longer).\n8. Use of erythropoiesis stimulating agents (unless stable for \\>8 weeks).\n9. Peripheral neuropathy ≥ Grade 2 (NCI CTCAE v 5.0).\n10. Unable or unwilling to undergo CT or MRI for spleen size imaging.\n11. Pregnant or breastfeeding.\n12. Requirement for therapy with a medication that is a strong CYP3A4 inhibitor as a concomitant medication.",{"count":105,"type":21},76,[55],"AJX-101 is a first-in-human (FIH), phase 1, non-randomized, multi-center, open-label clinical trial designed to investigate the safety, tolerability, pharmacokinetics (PK), clinical activity and changes in biomarkers of an orally administered type II JAK2 inhibitor, AJ1-11095, in subjects with primary or secondary myelofibrosis previously treated with at least one type I JAK2 inhibitor.",[25,109,110,111,112,113],"Post-Essential Thrombocythemia Myelofibrosis","Post-Polycythemia Vera Myelofibrosis","PMF","PPV-MF","PET-MF","2026-05-08",{"date":87,"type":36},{"date":117,"type":36},"2024-10-23",{"date":119,"type":21},"2027-02-15",{"name":121,"class":43},"Ajax Therapeutics, Inc.",21,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":53,"phases":133,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":52},"100555883","phase-2-study-of-momelotinib-in-combination-with-luspatercept-in-participants-with-transfusion-dependent-myelofibrosis-100555883","NCT06517875","Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis","A Phase 2 Open-label Study to Evaluate Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Primary or Secondary Myelofibrosis","ODYSSEY","Inclusion Criteria:\n\n1. Is age ≥18 years.\n2. Confirmed diagnosis of PMF in accordance with the World Health Organization (WHO) 2016 criteria, or Post-PV\u002FET myelofibrosis in accordance with the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria.\n3. JAKi naïve or previously treated with either ruxolitinib or fedratinib for PMF or Post-PV\u002FET myelofibrosis for ≥90 days, or ≥28 days if JAKi therapy is complicated by RBC transfusion requirement of ≥4 units in 8 weeks, or Grade 3\u002F4 AEs of thrombocytopenia, anemia, or hematoma.\n4. High risk, intermediate-2, or intermediate-1 risk as defined by Dynamic International Prognostic Scoring System (DIPSS) \\[Passamonti, 2010\\] or DIPSS-plus \\[Gangat, 2011\\].\n5. TD defined as requiring RBC transfusion ≥4 units or HgB \\\u003C 8 g\u002FdL in the 8 weeks prior to the first dose of study treatment (NOTE: 2 consecutive Hgb \\\u003C 8 g\u002FdL, at least 1 week apart are required; Hgb values impacted by transfusions are excluded). Only transfusions given when Hgb levels are ≤9.5 g\u002FdL are counted towards TD. RBC transfusions given for clinically overt bleeding, or accident\u002Finjury (as assessed by the investigator) are not counted towards TD.\n\nExclusion Criteria:\n\n1. History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (e.g., uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study intervention or result in inability to swallow oral medications.\n2. Participants with an invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years.\n3. Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, gastrointestinal bleeding, or thalassemia.\n4. Uncontrolled intercurrent illness:\n\n   1. Active uncontrolled infection (participants receiving outpatient antibacterial and\u002For antiviral treatments for infection that is under control or as infection prophylaxis may be included in the trial);\n   2. Significant active or chronic bleeding event ≥ Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, within 4 weeks prior to the first dose of study treatment; or\n   3. Uncontrolled acute and chronic liver disease (e.g., Child-Pugh score ≥10) OR has current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. NOTE: Stable chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) is acceptable if participant otherwise meets entry criteria.\n5. Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, that is not resolved at the time of the first dose of study treatment.\n6. Any of the following in conditions within 6 months prior to the first dose of study intervention:\n\n   1. Unstable angina pectoris; OR\n   2. Symptomatic congestive heart failure; OR\n   3. Uncontrolled cardiac arrhythmia\n7. QTc interval \\>450 msec or QTc \\>480 msec for participants with bundle branch block.\n8. Participants with stroke, deep venous thrombosis, pulmonary or arterial embolism within 6 months prior to the first dose of study intervention.\n9. History of porphyria.\n10. Presence of peripheral neuropathy ≥Grade 2 per CTCAE v5.0.\n11. Use of the following treatments within the time periods noted NOTE: All active anti-MF therapy must discontinue at least 1 week prior to the start of baseline MFSAF recording (Study Day -7):\n\n    1. Active anti-MF therapy within 28 days or 5 half-lives, whichever is shorter (exception is prior JAKi therapy).\n    2. Steroid use for the treatment of myelofibrosis is prohibited within 14 days prior to the first dose of study treatment until discontinuation of study treatment. Supportive care including steroids for non-myelofibrosis indications may be used.\n    3. Potent cytochrome P450 3A4 (CYP3A4) inducers, except for rifampin and rifampicin, within 14 days prior to the first dose of study intervention.\n    4. Any prior investigational agent for myelofibrosis within 4 weeks prior to the first dose of study treatment.\n    5. Erythropoiesis stimulating agent (ESA) within 4 weeks prior to the first dose of study treatment.\n    6. Splenic irradiation within 3 months prior to the first dose of study treatment.\n12. Prior treatment with MMB.\n13. Prior treatment with TGF-β pathway ligand traps (e.g., luspatercept or sotatercept).\n14. Prior splenectomy.\n15. Inability or unwillingness to comply with the protocol restrictions on myelofibrosis therapy and other medications prior to and during study treatment.\n16. Unresolved non-hematologic toxicities from prior therapies that are \\>Grade 1 per CTCAE v5.0 unless otherwise specified.\n17. Known positive status for human immunodeficiency virus (HIV).\n18. Hepatitis A, B, or C status as defined below:\n\n    1. Chronic active or acute viral hepatitis A.\n    2. Active Hepatitis B infection indicated by the presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to the first dose of study intervention.\n    3. Positive hepatitis C antibody test result at screening or within 3 months before the first dose of study intervention. NOTE: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative hepatitis C ribonucleic acid (RNA) test is obtained.\n19. Women who are already pregnant or lactating.",{"count":132,"type":21},68,[56],"The purpose of this Phase 2 study is to evaluate the efficacy and safety of momelotinib (MMB) in combination with luspatercept (LUSPA) in participants with transfusion dependence (TD) primary myelofibrosis (PMF) or Post-polycythemia vera (PV)\u002F essential thrombocythemia (ET) myelofibrosis (MF) who are either janus kinase (JAK) inhibitor (JAKi) naïve or experienced.",[25,136],"Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis",[138],"Momelotinib; Luspatercept; Primary Myelofibrosis; Secondary Myelofibrosis; JAK inhibitor; anemia transfusion; Ojjara; Omjjara; Reblozyl","2026-04-17",{"date":141,"type":36},"2026-04-20",{"date":143,"type":36},"2025-02-28",{"date":145,"type":21},"2028-03-17",{"name":147,"class":43},"GlaxoSmithKline",{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":17,"minAge":155,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":53,"phases":159,"briefSummary":160,"conditions":161,"keywords":165,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":44},"100519771","phase-1-uab-2419-cd34-selection-using-the-automated-clinimacs-prodigy-100519771","NCT06047886","UAB 2419-CD34 Selection Using the Automated CliniMACS Prodigy","Feasibility Study of CD34 Selection for GVHD Prophylaxis Using the Automated CliniMACS","Inclusion Criteria:\n\n1. AML in morphologic remission with intermediate\u002Fhigh-risk features or relapsed disease 1 or 2\n2. ALL in morphologic remission with high-risk features or relapsed disease 1 or 2\n3. Lymphoid malignancies in CR or PR (e.g. non-Hodgkin's lymphoma, prolymphocytic leukemia, CLL)\n4. Myelodysplastic syndromes with \\\u003C=10% blasts\n5. CML in morphologic remission after blast phase or accelerated phase\n6. Primary myelofibrosis with \\\u003C=10% blasts \\^morphologic remission is defined as \\\u003C5% blasts on the bone marrow biopsy. Negative test for donor-specific antibody within 28 days of starting conditioning regimen, or adequate for standard desensitization protocol.\n\nExclusion Criteria:\n\n1. Non-compliant patients.\n2. No appropriate caregivers identified.\n3. Uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (Discretion of the attending physician).\n4. Patients with known allergy to DMSO.\n5. Pregnant or breastfeeding women","4 Weeks","75 Years",{"count":158,"type":21},50,[55],"Patients with graft failure or delayed engraftment may benefit from a hematopoietic stem cell boost or an additional hematopoietic stem cell transplantation procedure. In such settings standard immune suppression strategies are avoided due to their myelosuppressive nature. Therefore those patients are at increased risk of graft versus host disease, and the infusion of a CD34 selected graft would reduce such a risk. The infusion of CD34 selected graft using CliniMACS plus is currently FDA FDA-approved indication for acute myeloid leukemia. However, the use of the Prodigy would streamline the processing, in terms of hands-off procedure, allowing to provision of this product to the patients without strains on the cell therapy lab team. This procedure has been demonstrated safe and effective in several single-center studies and is currently in advanced phase investigation in several studies for malignant and non-malignant conditions.",[162,17,163,83,164,25],"AML","Lymphoid Malignancies","CML",[166,167],"hematologic malignancies","graft failure","2026-04-08",{"date":170,"type":36},"2026-04-13",{"date":172,"type":36},"2025-04-22",{"date":174,"type":21},"2029-12",{"name":176,"class":69},"University of Alabama at Birmingham",{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":53,"phases":186,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":122},"100543112","phase-3-a-study-to-evaluate-safety-and-efficacy-of-bomedemstat-mk-3543-017-100543112","NCT06351631","A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)","A Multicenter, Open-Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for the Treatment of Participants Enrolled in a Prior Bomedemstat Clinical Study","Inclusion Criteria:\n\n* Is from a bomedemstat study sponsored by Imago BioSciences, Inc. (a subsidiary of Merck \\& Co., Inc.) or MSD, and established by the Sponsor as MK-3543-017 ready\n* Has received at least 6 months of treatment with bomedemstat in the IMG-7289-202\u002FMK-3543-005 study, while safely tolerating bomedemstat, and receiving clinical benefit from its use in the estimation of the investigator\n* ET and PV participants from established feeder studies other than IMG-7289- 202\u002FMK-3543-005 must have achieved confirmed hematologic remission, must be safely tolerating bomedemstat, and must be receiving clinical benefit from its use in the estimation of the investigator\n* Is not currently on a dose hold\n* Participant must be able to swallow oral medication and follow instructions for at-home dosing of bomedemstat\n\nExclusion Criteria:\n\n* Has received prohibited concomitant medications\n* Ongoing or planned participation in another investigational study\n* Has noncompliance in prior bomedemstat study receiving \\\u003C90% of assigned doses excluding suspensions or holds as assigned by the investigator",{"count":185,"type":21},400,[187],"PHASE3","The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria:\n\n* Participants from the IMG-7289-202\u002FMK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat;\n* Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202\u002FMK-3543-005 must have achieved confirmed hematologic remission.\n\nNo hypothesis testing will be conducted in this study.",[190,25,31,27,28,191],"Thrombocythemia, Essential","Polycythemia Vera","2026-04-01",{"date":194,"type":36},"2026-04-02",{"date":196,"type":36},"2024-05-23",{"date":198,"type":21},"2034-12-04",{"name":200,"class":43},"Merck Sharp & Dohme LLC",{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":53,"phases":209,"briefSummary":210,"conditions":211,"keywords":217,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":44},"100384169","phase-2-decitabine-with-ruxolitinib-fedratinib-or-pacritinib-for-the-treatment-of-acceleratedblast-phase-myeloproliferative-neoplasms-100384169","NCT04282187","Decitabine With Ruxolitinib, Fedratinib or Pacritinib for the Treatment of Accelerated\u002FBlast Phase Myeloproliferative Neoplasms","A Phase 2 Trial Investigating Decitabine in Combination With a JAK-Inhibitor as a Bridge to Allogeneic Hematopoietic Stem Cell Transplant in Patients With Accelerated\u002FBlast Phase Myeloproliferative Neoplasms","Inclusion Criteria:\n\n* Age \\>= 18 years\n* History of MPN as defined by the 2016 World Health Organization criteria, with now pathologically confirmed \\>= 5% blasts in the bone marrow or peripheral blood. Prior MPNs could include polycythemia vera, essential thrombocythemia, primary myelofibrosis, secondary myelofibrosis, MPN unclassifiable, MDS\u002FMPN overlap\n* Outside diagnostic material is acceptable as long as peripheral blood and\u002For bone marrow slides are reviewed at the study institution by pathology. Flow cytometric analysis of peripheral blood and\u002For bone marrow should be performed according to institutional practice guidelines\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or Karnofsky \\>= 60%\n* Serum creatinine clearance \\>= 50 ml\u002Fmin calculated by the Cockcroft-Gault Equation (assessed within 14 days of study day 1)\n* Total bilirubin =\\\u003C 3 unless due to Gilbert's disease or hemolysis (total bilirubin \\> 3 is allowable if thought due to Gilbert's disease, hemolysis, or MPN disease) (assessed within 14 days of study day 1)\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) \\\u003C 3 x upper limit of normal (ULN) unless thought to be due to MPN disease process (AST\u002FALT \\> 3 is allowable if thought due to MPN disease) (assessed within 14 days of study day 1)\n* For patient receiving fedratinib, thiamine level should be above the laboratory lower limit of normal (\\>= 70 nmol\u002FL in the University of Washington \\[UW\\]\u002FSeattle Cancer Care Alliance \\[SCCA\\] lab). If it is low, it may be repleted but should be rechecked and demonstrated to normalize prior to initiation of therapy\n* Patient is considered a potential transplant candidate. The attending\u002Ftreating physician will determine transplant candidacy at the time of consent\n* The use of hydroxyurea prior to study registration is allowed. Patients with symptoms\u002Fsigns of hyperleukocytosis, white blood count (WBC) \\> 100,000\u002FuL, or with concern for other complications of high tumor burden or leukostasis (e.g. hypoxia, disseminated intravascular coagulation) can be treated with leukapheresis or may receive up to 2 doses of cytarabine (up to 500 mg\u002Fm\\^2 \u002Fdose) anytime prior to enrollment\n* Capable of providing valid informed consent\n\nExclusion Criteria:\n\n* Previous treatment with chemotherapy (e.g. hypomethylating agents or cytarabine-based regimens) for MPN with \\>= 5% blasts in the blood or marrow. Prior temporary measures to control blood counts is allowed. Prior treatment with hydroxyurea, interferons or JAK inhibitor therapy is allowed\n* Active systemic fungal, bacterial, viral, or other infection, unless disease is under treatment with anti-microbials and\u002For controlled or stable (e.g. if specific, effective therapy is not available\u002Ffeasible or desired \\[e.g. chronic viral hepatitis, human immunodeficiency virus (HIV)\\])\n* Known hypersensitivity to any study drug\n* Females who are pregnant or breastfeeding\n* Treatment with any other anti-MDS\u002Fleukemia investigational agent within 2 weeks of start of study drugs\n* For patients planning to receive fedratinib: concurrent use of strong and moderate CYP3A4 inducers or dual CYP3A4 and CYP2C19 inhibitors that cannot be discontinued\n* For patients planned to receive ruxolitinib AND platelets \\\u003C 50,000\u002Fmm\\^2: concurrent use of a strong CYP3A4 inhibitor that cannot be discontinued\n* For patients planned to receive pacritinib, corrected QT interval (QTc) \\> 480 msec (changing of medications\u002Fsupplementing electrolytes is allowed to determine if this helps QTc reduce to \\\u003C 480 msec)\n* For patients planned to receive pacritinib, concurrent use of medications that are CYP1A2, CYP3A4, P-gp, BCRP, OCT1 substrates that cannot be discontinued",{"count":96,"type":21},[56],"This phase II trial studies how well decitabine with ruxolitinib, fedratinib, or pacritinib works before hematopoietic stem cell transplant in treating patients with accelerated\u002Fblast phase myeloproliferative neoplasms (tumors). Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ruxolitinib, fedratinib, and pacritinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy before a donor hematopoietic stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells. Decitabine, with ruxolitinib, fedratinib, or pacritinib may work better than multi-agent chemotherapy or no pre-transplant therapy, in treating patients with accelerated\u002Fblast phase myeloproliferative neoplasms.",[212,213,214,215,85,216,191,25,26],"Acute Myeloid Leukemia","Essential Thrombocythemia","Myelodysplastic Syndrome","Myelodysplastic\u002FMyeloproliferative Neoplasm","Myeloproliferative Neoplasm, Not Otherwise Specified",[218,219],"Myeloid and Monocytic Leukemia","Other Hematopoietic","2026-03-11",{"date":222,"type":36},"2026-03-16",{"date":224,"type":36},"2020-03-24",{"date":226,"type":21},"2026-11-11",{"name":228,"class":69},"University of Washington",{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":156,"enrollmentInfo":236,"targetDuration":4,"studyType":53,"phases":237,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":44},"100610518","phase-2-ruxolitinib-before-during-and-after-hematopoietic-cell-transplant-in-older-patients-with-myelofibrosis-and-myelodysplastic-syndromemyeloproliferative-neoplasm-overlap-syndromes-100610518","NCT07228624","Ruxolitinib Before, During and After Hematopoietic Cell Transplant in Older Patients With Myelofibrosis and Myelodysplastic Syndrome\u002FMyeloproliferative Neoplasm Overlap Syndromes","Peri-Hematopoietic Cell Transplantation Ruxolitinib in Patients With Myelofibrosis and Myelodysplastic Syndrome\u002FMyeloproliferative Neoplasm Overlap Syndromes","Inclusion Criteria:\n\n* PART 1 JAK INHIBITOR ADMINISTRATION: Age 18-75 years\n\n  * Patients \\> 75 must be considered an HCT candidate, meet all protocol criteria and have comorbidity score =\\\u003C 3 and Karnofsky performance status (KPS) \\> or = to 90. Patients. \\> 75 who do not meet these criteria may be presented at PCC for consensus exception\n* PART 1 JAK INHIBITOR ADMINISTRATION: Disease criteria\n\n  * Diagnosis of primary or secondary MF as defined by the 2022 World Health Organization classification system or the International Consensus Classification for Myeloid and Acute Leukemias\n  * Diagnosis of an MDS\u002FMPN overlap syndrome as defined by the 2022 World Health Organization\n* PART 1 JAK INHIBITOR ADMINISTRATION: Ability to understand and the willingness to sign a written informed consent document\n* PART 1 JAK INHIBITOR ADMINISTRATION: Patient must be a potential HCT candidate as assessed by the consenting physician\n* PART 1 JAK INHIBITOR ADMINISTRATION: Patient must be agreeable to taking a JAK-inhibitor (ruxolitinib preferred) for at least 8 consecutive weeks immediately prior to conditioning and be willing to take ruxolitinib 5mg BID starting from day -4 prior to and continuing until 12 months post-transplant as tolerated followed by a 6-month taper.\n* PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Meeting criteria for Part 1 at time of initiation of JAK-inhibitor, including the ability to understand and willingness to sign a written informed consent. Patients arriving to our institution for HCT and not enrolled in Part 1 may still be enrolled in Part 2 if Part 1 criteria are met. These patients will have Part 1 endpoints transcribed from their medical records\n* PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Received a JAK-inhibitor for at least 8 weeks immediately prior to conditioning and be willing to take Rux from day -4 at the 5mg BID dose until 12 months post-transplant as tolerated followed by a 6 month taper\n* PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Performance status score\n\n  * Karnofsky ≥ 70 or \\> 90 for patients \\> 75 years old\n* PART 2 ALLOGENEIC STEM CELL TRANSPLANT: HCT-CI Score \\\u003C 8; if patient is \\> 75 years old HCT-CI \\\u003C 3\n* PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Calculated creatinine clearance using the Cockcroft-Gault formula or 24-hour urine creatinine clearance must be \\> 60 ml\u002Fmin\n* PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Total serum bilirubin must be \\\u003C 3mg\u002FdL unless the elevation is thought to be due to Gilbert's disease or hemolysis\n* PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Transaminases must be \\\u003C 3 x the upper limit of normal\n* PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Patients with clinical or laboratory evidence of liver disease will be evaluated for the cause of liver disease, its clinical severity in terms of liver function, and the degree of portal hypertension. Patients with fulminant liver failure, cirrhosis with evidence of portal hypertension or bridging fibrosis, alcoholic hepatitis, hepatic encephalopathy, or correctable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin \\> 3mg\u002FdL, and symptomatic biliary disease will be excluded\n* PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Diffusion capacity of lung for carbon monoxide (DLCO) corrected \\> 60% normal. Patient may not be on oxygen\n* PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Left ventricular ejection fraction \\> 40%\n* DONOR: Human leukocyte antigen (HLA)-matched sibling donor\n* DONOR: 10 of 10 HLA-matched unrelated donor\n* DONOR: 9 of 10 allele or antigen mismatched unrelated donor\n* DONOR: Peripheral blood is preferred over bone marrow\n* DONOR: Matched unrelated donors may be preferred over siblings if the unrelated donor is \\\u003C 30 years and the sibling is \\> 60 years. However, sibling donors \\\u003C 70 should be preferred over mismatched unrelated donors\n\nExclusion Criteria:\n\n* PART 1 JAK INHIBITOR ADMINISTRATION: Contraindication to receiving ruxolitinib including patients who have known hypersensitivity to JAK inhibitors and excipients\n* PART 1 JAK INHIBITOR ADMINISTRATION: History of prior allogeneic transplant\n* PART 1 JAK INHIBITOR ADMINISTRATION: Leukemic transformation (\\> 20% blasts)\n* PART 1 JAK INHIBITOR ADMINISTRATION: Uncontrolled viral, bacterial, or fungal infection despite being on therapy\n* PART 1 JAK INHIBITOR ADMINISTRATION: History of HIV infection\n* PART 1 JAK INHIBITOR ADMINISTRATION: History of untreated tuberculosis (TB)\n* PART 1 JAK INHIBITOR ADMINISTRATION: Pregnant or breastfeeding\n* PART 1 JAK INHIBITOR ADMINISTRATION: Patients with history of myocardial infarction (MI), cerebrovascular accident (CVA) or unprovoked pulmonary embolism (PE)\u002Fdeep vein thrombosis (DVT) in the past 6 months\n* PART 1 JAK INHIBITOR ADMINISTRATION: Secondary malignancy in last 5 years with \\> 20% risk of relapse\n* PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Contraindication to receiving ruxolitinib including patients who have known hypersensitivity to JAK inhibitors and excipients\n* PART 2 ALLOGENEIC STEM CELL TRANSPLANT: History of prior allogeneic transplant\n* PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Leukemic transformation (\\> 20% blasts)\n* PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Uncontrolled viral or bacterial infection at the time of transplant data review and consent conference\n* PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Active or recent (prior 6 month) invasive fungal infection without infectious disease (ID) consult and approval\n* PART 2 ALLOGENEIC STEM CELL TRANSPLANT: History of HIV infection\n* PART 2 ALLOGENEIC STEM CELL TRANSPLANT: History of untreated TB\n* PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Requiring supplemental oxygen\n* PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Pregnant or breastfeeding\n* PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Secondary malignancy in last 5 years with \\> 20% risk of relapse\n* PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Patients with a history of MI, CVA, or unprovoked PE\u002FDVT in the past 6 months\n* PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Patients without an HLA-identical sibling donor, 10 of 10 HLA-matched or 9 of 10 mismatched unrelated donor",{"count":158,"type":21},[56],"This phase II trial tests the effect of adding ruxolitinib to standard graft versus host disease (GVHD) prevention in treating older patients with myelofibrosis (MF) or myelodysplastic syndrome\u002Fmyeloproliferative neoplasm (MDS\u002FMPN) overlap syndromes before, during, and after a donor (allogeneic) hematopoietic cell transplant (HCT). Allogeneic HCT is a procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a genetically similar, but not identical donor. Giving chemotherapy, such as cytoxan and busulfan or fludarabine and melphalan, before a donor transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. However, sometimes the transplanted cells from a donor can attack the body's normal cells (called GVHD). Giving standard prevention (prophylaxis) therapies, such as tacrolimus and methotrexate, after the transplant may stop this from happening. Methotrexate, a type of antifolate, is in a class of medications called antimetabolites. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid and may kill cancer cells. Tacrolimus is used to help reduce the risk of rejection by the body of organ and bone marrow transplants. Ruxolitinib, a type of Janus-associated kinase (JAK) inhibitor, blocks a protein called JAK, which may help keep abnormal blood cells or cancer cells from growing. It may also lower the body's immune response and prevent the development of GVHD. Giving ruxolitinib before, during and after allogeneic HCT in addition to standard GVHD prophylaxis may be safe, tolerable and effective in preventing GVHD and improving outcomes in older patients with MF or MDS\u002FMPN overlap syndrome.",[215,25,26],"2026-02-17",{"date":38,"type":36},{"date":243,"type":36},"2026-02-04",{"date":245,"type":21},"2030-09-01",{"name":247,"class":69},"Fred Hutchinson Cancer Center",{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":255,"enrollmentInfo":256,"targetDuration":4,"studyType":53,"phases":258,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":44},"100390926","phase-2-reduced-intensity-haploidentical-transplantation-for-the-treatment-of-primary-or-secondary-myelofibrosis-100390926","NCT04370301","Reduced Intensity Haploidentical Transplantation for the Treatment of Primary or Secondary Myelofibrosis","Pilot Study of JAK Inhibitor Therapy Followed by Reduced Intensity Haploidentical Transplantation for Patients With Myelofibrosis","Inclusion Criteria:\n\n* PART 1: JAK INHIBITOR ADMINISTRATION INCLUSION CRITERIA\n* Age between 18 and 70 years\n* Diagnosis of primary myelofibrosis (PMF) as defined by the 2016 World Health Organization classification system or diagnosis of secondary MF as defined by the International Working Group (IWG) for Myeloproliferative Neoplasms Research and Treatment criteria\n* Patients meeting the criteria for intermediate-1, intermediate-2 or high-risk disease by the Dynamic International Prognostic Scoring System (DIPSS)-plus scoring system (DIPSS may be used if all data from DIPSS are not available)\n* Ability to understand and the willingness to sign a written informed consent document (or legally authorized representative)\n* Patient must be a potential hematopoietic stem cell transplant candidate\n* PART 2: ALLOGENEIC STEM CELL TRANSPLANT INCLUSION CRITERIA\n* Meeting criteria for 1st phase as above, at time of initiation of JAK inhibitor, including ability to understand and willingness to sign a written informed consent (or legally authorized representative). Patients arriving to our institution for transplant and not enrolled in Part 1 may still be enrolled in Part 2 if Part 1 criteria met. These patients will have Part 1 endpoints transcribed from medical records\n* Received JAK inhibitor for at least 8 weeks immediately prior to conditioning and be willing to continue until 9-12 months post-transplant as tolerated\n* Karnofsky performance status score \\>= 70\n* Calculated creatinine clearance using the Cockcroft-Gault formula or 24 hour (hr) urine creatinine clearance must be \\> 60 ml\u002Fmin\n* Total serum bilirubin must be \\\u003C 3 mg\u002FdL unless the elevation is thought to be due to Gilbert's disease or hemolysis\n* Transaminases must be \\\u003C 3 x the upper limit of normal\n* Patients with clinical or laboratory evidence of liver disease will be evaluated for the cause of liver disease, its clinical severity in terms of liver function, and the degree of portal hypertension. Patients with fulminant liver failure, cirrhosis with evidence of portal hypertension or bridging fibrosis, alcoholic hepatitis, hepatic encephalopathy, or correctable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin \\> 3 mg\u002FdL, and symptomatic biliary disease will be excluded\n* Diffusion capacity of the lung for carbon monoxide (DLCO) corrected \\> 60% normal; may not be on supplemental oxygen\n* Left ventricular ejection fraction \\> 40% OR shortening fraction \\> 26%\n* Comorbidity Index \\\u003C 5 at the time of pre-transplant evaluation\n* DONOR: Patients must be screened prior to transplant for donor-specific anti-HLA antibodies (DSA). Patients with DSA will be reviewed by the principal investigator and considered for desensitization treatment\n* DONOR: Children are preferred over siblings and parents\n* DONOR: Younger donors are preferred over older donors\n* DONOR: ABO matched donors are preferred over minor ABO mismatched and over major ABO mismatch donors\n\nExclusion Criteria:\n\n* PART 1: JAK INHIBITOR ADMINISTRATION EXCLUSION CRITERIA\n* Contraindication to receiving a JAK inhibitor including:\n\n  * Patients who have known hypersensitivity to JAK inhibitors\n  * Clinical or laboratory evidence of significant renal or hepatic impairment including cirrhosis\n  * Active uncontrolled infection\n  * Known human immunodeficiency virus (HIV) positivity\n  * Women who are pregnant or trying to conceive\n  * Caution should be used in patients with platelets \\\u003C 100 though adjustments in dose can be made to accommodate anyone with platelets \\> 50\n* History of prior allogeneic transplant\n* Leukemic transformation (\\> 20% blasts)\n* PART 2: ALLOGENEIC STEM CELL TRANSPLANT EXCLUSION CRITERIA\n* Uncontrolled viral or bacterial infection at the time of study enrollment\n* Active or recent (prior 6 month) invasive fungal infection without infectious disease (ID) consult and approval\n* Known HIV positivity\n* Pregnant or breastfeeding\n* Availability of an human leukocyte antigen (HLA)-identical or 1-allele-mismatched related donor or an HLA 10 of 10 matched unrelated donor","70 Years",{"count":257,"type":21},20,[56],"This initial cohort of this phase II trial studied the outcomes of using a JAK inhibitor prior to reduced intensity haploidentical (Haplo) transplantation for the treatment of primary or secondary myelofibrosis (MF). The primary risk of using Haplo HCT in patients with MF is graft failure. In the first cohort, all patients engrafted. There were no instances of graft failure. However, a large number of patients did have graft versus host disease as a complication of their transplant. JAK inhibitors have since been approved for the indication of graft versus host disease treatment. And we are also using them for graft versus host disease prevention in a study of MF patients with sibling and unrelated donors. Therefore, we are opening a new cohort of the current study using the JAK inhibitor prior to, during and after Haplo transplant. Our goal is to decrease graft versus host disease in patients receiving a Haplo MF transplant without increasing the risk of graft failure.",[25,26],"2026-01-08",{"date":263,"type":36},"2026-01-12",{"date":265,"type":36},"2021-02-09",{"date":267,"type":21},"2029-08-31",{"name":247,"class":69},{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":53,"phases":279,"briefSummary":281,"conditions":282,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":293},"100543882","functional-and-phenotypic-characterization-of-monocytes-in-myeloproliferative-syndromes-100543882","NCT06361641","Functional and Phenotypic Characterization of Monocytes in Myeloproliferative Syndromes","Functional and Phenotypic Characterization of Monocytes in Myeloproliferative Syndromes-PHEMOP","PHEMOP","Inclusion Criteria:\n\n* Diagnosis of PV, ET, pre-myelofibrosis or primary myelofibrosis according to WHO 2022 criteria (including BOM for ET, premyelofibrosis and primary myelofibrosis)\n* Patient who has not received treatment specific to hemopathy at the time of sampling\n* Obtaining the signature of consent to participate in the study\n* Patient having consented to be included in the \"Malignant Hemopathy\" collection of Angers University Hospital and in FIMBANK database\n\nExclusion Criteria:\n\n* Person not affiliated to a social security scheme or beneficiary of such a scheme\n* Patient with another hemopathy or another active cancer at the time of diagnosis\n* Minor patient at diagnosis (\\\u003C 18 years old)\n* Patient not capable or without agreement from the guardian or legal representative",{"count":278,"type":21},70,[280],"NA","Prospective study for functional and phenotypic characterization of monocytes in philadelphia-negative myeloproliferative neoplasms",[85,191,213,25],"2025-12-02",{"date":285,"type":36},"2025-12-08",{"date":287,"type":36},"2024-05-29",{"date":289,"type":21},"2028-10-19",{"name":291,"class":292},"University Hospital, Angers","OTHER_GOV",3,{"id":295,"slug":296,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":300,"eligibilityCriteria":301,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":53,"phases":304,"briefSummary":305,"conditions":306,"keywords":310,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":326},"100552903","phase-3-study-of-navtemadlin-add-on-to-ruxolitinib-in-jak-inhibitor-nave-patients-with-myelofibrosis-who-have-a-suboptimal-response-to-ruxolitinib-100552903","NCT06479135","Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib","A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib","POIESIS","Inclusion Criteria for Ruxolitinib Alone Period:\n\n* Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by the treating physician according to the World Health Organization (WHO) criteria\n* High, Intermediate-1, Intermediate-2 risk category International Prognosis System Score (IPSS)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* JAK-inhibitor treatment naive\n\nExclusion Criteria for Ruxolitinib Alone Period:\n\n* Prior Splenectomy\n* Splenic irradiation within 3 months prior to the first dose\n* Prior BCL-XL, BET, MDM2, PI3K, PIM, or XPO1 inhibitors therapy or p53-directed therapy\n* Eligible for Bone Marrow Transplant\n* Peripheral blood or bone marrow blast count ≥ 10 percent\n\nInclusion Criteria for Randomized Period:\n\n* PMF, post-PV MF, or post-ET MF that is TP53WT as assessed by central testing\n* ECOG performance status of 0 to 2\n* Treatment with a stable dose of ruxolitinib\n* Suboptimal response to run-in ruxolitinib treatment\n\nExclusion Criteria for Randomized Period:\n\n* Elevated white blood cell count that doubles (or more) during ruxolitinib treatment and exceeds 50 × 10\\^9\u002FL\n* Peripheral blood or bone marrow blast count ≥ 10 percent",{"count":303,"type":21},600,[187],"This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib treatment will provide more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone.\n\nSubjects will start by receiving ruxolitinib alone in the run-in period. Those who demostrate a suboptimal response from ruxolitinib alone will then be randomized 2:1 to receive navtemadlin or navtemadlin placebo as add-on treatment to their ongoing ruxolitinib. Randomized means that subjects will be assigned to a group by chance, like a flip of a coin. The study is blinded, meaning the subjects, doctors, central endpoint assessors and sponsor will not know which add on treatment (navtemadlin or navtemadlin placebo) the subject is receiving.",[31,307,308,25,309],"Post-PV MF","Post-ET Myelofibrosis","MF",[311,312,313,300,314,315,316],"Navtemadlin","KRT-232","Ruxolitinib","TP53","Suboptimal response","Sub-optimal response","2025-09-22",{"date":319,"type":36},"2025-09-25",{"date":321,"type":36},"2024-06-03",{"date":323,"type":21},"2028-12-31",{"name":325,"class":43},"Kartos Therapeutics, Inc.",215,{"id":328,"slug":329,"hasResults":11,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":53,"phases":335,"briefSummary":336,"conditions":337,"keywords":338,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":44},"100552049","phase-3-p1101-in-treating-patients-with-early-pmf-or-overt-pmf-at-low-or-intermediate-1-risk-100552049","NCT06468033","P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk","A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III Study to Assess Efficacy and Safety of Ropeginterferon Alfa-2b (P1101) in Adult Patients With Pre-fibrotic\u002FEarly Primary Myelofibrosis (PMF) or Overt PMF at Low or Intermediate-1 Risk According to DIPSS Plus (HOPE-PMF): The Core Study and Its Extension Study","Inclusion Criteria:\n\n1. Male or female patients aged ≥18 years at the time of signing the informed consent form;\n2. Patients with pre-fibrotic\u002Fearly PMF (Pre-PMF) or overt primary myelofibrosis at low to intermediate-1 risk according to DIPSS plus, diagnosed according to WHO 2016 or 2022 classification;\n3. With good liver function at screening, which is defined as total bilirubin ≤1.5 × upper limit of normal (ULN), international normalized ratio (INR) ≤1.5 × ULN, albumin \\>3.5 g\u002FdL, alanine aminotransferase (ALT) ≤2.0 × ULN, and aspartate aminotransferase (AST) ≤2.0 × ULN;\n4. Hgb ≥10.0 g\u002FdL at screening;\n5. Neutrophil count ≥1.0 × 10\\^9\u002FL at screening;\n6. Creatinine clearance rate ≥30 mL\u002Fmin at screening (according to the Cockcroft-Gault formula);\n7. Females of childbearing potential, as well as all women \\<2 years after the onset of menopause, must agree to use an acceptable form of birth control until 60 days following the last dose of the study drug, and females must agree to not breastfeed during the study;\n8. Written informed consent obtained from the subject and ability for the subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n1. Any known contraindications to interferon α or hypersensitivity to interferon α;\n2. Patients with prior interferon therapy having poor tolerability or lack of efficacy to the previous interferon therapy per investigator\\'s judgement;\n3. Patients with an ongoing cytoreduction (e.g., HU or IFN-α) at the time of screening if, in the Investigator's opinion, randomizing them into the placebo arm will lead to immediate rebound increase of peripheral blood counts and thus may jeopardize their health status;\n4. With severe or serious diseases that, in the Investigator's opinion, may affect the patient's participation in this study;\n5. History of major organ transplantation;\n6. Pregnant or breastfeeding women;\n7. Patients with any other diseases that will affect the study results or may weaken the compliance to protocol per the Investigator's judgment;\n8. Use any investigational drug \\<4 weeks prior to the first dose of study drug, or not recovered from effects of prior administration of any investigational drug.\n9. Eligible for JAK inhibitor therapy at screening.",{"count":78,"type":21},[187],"This is a phase 3 double-blind clinical trial arm to test Ropeginterferon alfa-2b (P1101) in adult patients with Primary Myelofibrosis (PMF) at early stage or low to medium risk.\n\nParticipants will receive the study drug\u002Fplacebo bi-weekly and have an assessment visit every 4 weeks. The ratio of study drug to placebo group is 2:1.",[25,85],[339,25,111,340,341,342,343,344,345],"P1101","Ropeginterferon","PharmaEssentia","Myeloproliferative neoplasms","MPN","Pre-fibrotic","Low or Intermediate-1 Risk","2025-08-08",{"date":348,"type":36},"2025-08-13",{"date":350,"type":36},"2025-07-18",{"date":352,"type":21},"2028-09-30",{"name":341,"class":43},{"id":355,"slug":356,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":361,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":364,"conditions":365,"keywords":366,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":44},"100584975","role-of-mesenchymal-stromal-cell-derived-extracellular-vesicles-of-primary-myelofibrosis-patients-on-cd34-cells-100584975","NCT06896344","Role of Mesenchymal Stromal Cell Derived Extracellular Vesicles of Primary Myelofibrosis Patients on CD34+ Cells","Microenvironment Cross-talk: Role of Extracellular Vesicles Derived From Mesenchymal Stromal Cells of Patients With Primary Myelofibrosis in Modifying Functional Activities of CD34+ Hematopoietic Progenitor Cells","Inclusion Criteria:\n\n* Patients with PMF\n* JAK2 V617F+ (either homozygous or heterozygous)\n* Out of therapy\n* At least 18 years old\n\nExclusion Criteria:\n\n* PMF combined to other pathologies\n* Previous splenectomy\n* Previous bone marrow transplant",true,{"count":363,"type":21},10,"The aim of this study is to demonstrate that, in patients with myelofibrosis (PMF), a chronic neoplastic disease of the bone marrow, some of the cells that form the bone marrow microenvironment (mesenchymal stromal cells, MSCs) can send wrong messages to the CD34+ hematopoietic progenitor cells (HPCs). CD34+ HPCs in normal conditions reside in the bone marrow until complete maturation; in PMF they leave the bone marrow when they are still progenitor cells and frequently they express the V617F mutation on the JAK2 molecule. In previously published papers, the investigators demonstrated that the MSCs in the bone marrow of patients with PMF are different from those in healthy donors. In this study the investigators want to verify how this difference affects the maturation of CD34+ HPCs of healthy donors and of SET2 cells, a commercially available cell line characterized by the V617F mutation of the JAK2 molecule. In particular, the investigators will verify the effect of MSCs on signals that induce the activation of CD34+ cells, their survival or death, the production of harmful oxidative reagents and their clonal capacity. To obtain these data, the investigators will isolate MSCs from bone marrow blood samples of patients with PMF undergoing bone marrow biopsy for clinical reasons and from healthy subjects, donors of HPCs for transplant. Following a long culture MSCs will be stimulated to release small vescicles containing part of their nuclear and cytoplasmatic molecules. These vescicles will be cultured with CD34+ cells or SET2 cells and their effects will be evaluated. It has been shown that these small vescicles act exactly like MSCs, but they are easier to be used, and could become a very useful acellular drug in the near future.",[25],[25,367,368],"CD34","extracellular vesicles","2025-03-27",{"date":371,"type":36},"2025-04-02",{"date":373,"type":36},"2024-01-11",{"date":375,"type":21},"2025-08",{"name":377,"class":69},"Fondazione IRCCS Policlinico San Matteo di Pavia",{"id":379,"slug":380,"hasResults":11,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":385,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":387,"conditions":388,"keywords":389,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":44},"100527696","68ga-fapi-petct-imaging-for-diagnosis-grading-and-efficacy-evaluation-of-myelofibrosis-100527696","NCT06151119","68Ga-FAPI PET\u002FCT Imaging for Diagnosis, Grading, and Efficacy Evaluation of Myelofibrosis.","A Study to Evaluate 68Ga-FAPI PET\u002FCT Imaging for Diagnosis, Grading, and Efficacy Evaluation of Myelofibrosis.","Inclusion Criteria:\n\n1. Age ≥18 years old;\n2. Cohort 1: Patients with suspected or confirmed myelofibrosis; Cohort 2: Patients with primary\u002Fsecondary myelofibrosis who were not treated with ruxolitinib.\n3. The expected survival time is over 3 months\n4. Voluntarily sign informed consent.\n5. Willing and able to follow the research protocol;\n6. The subject must be able to lie on the scanning bed for 20 minutes;\n\nExclusion Criteria:\n\n1. Known allergic history to 68Ga FAPI or its excipients;\n2. Patients who can not tolerate intravenous drug administration (such as needle fainting and blood fainting history);\n3. Those who are not suitable for or unable to complete imaging tests such as PET due to special reasons, including claustrophobia and radiophobia;\n4. pregnant and lactating women;\n5. Workers who are exposed to radiation for a long period of time;\n6. Serious diseases of the heart, kidney, lung, blood vessel, nervous system, mental system, immune deficiency diseases and hepatitis\u002Fcirrhosis;\n7. Participating in other interventional clinical trials within 1 month before screening;\n8. Patients undergoing chemotherapy, immunotherapy or molecular targeted therapy due to other cancers;\n9. There are other circumstances that the researcher thinks are not suitable for participating in this study;",{"count":386,"type":21},90,"To evaluate the diagnostic efficacy of 68Ga FAPI PET\u002FCT in myelofibrosis and to identify fibrosis grades.\n\nTo evaluate the diagnostic efficacy of 68Ga FAPIPET\u002FCT imaging in patients with myelofibrosis, compared with conventional CT.",[25],[31,390],"positron emission tomography \u002F computed tomography","2025-02-18",{"date":393,"type":36},"2025-02-19",{"date":395,"type":36},"2023-11-22",{"date":397,"type":21},"2027-06-30",{"name":399,"class":69},"The First Affiliated Hospital of Xiamen University",{"id":401,"slug":402,"hasResults":11,"nctId":403,"briefTitle":404,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":406,"targetDuration":408,"studyType":22,"phases":4,"briefSummary":409,"conditions":410,"keywords":411,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":423},"100555770","ruxolitinib-in-primary-myelofibrosis-and-secondary-to-essential-thrombocythemia-or-polycythemia-vera-100555770","NCT06516406","Ruxolitinib in Primary Myelofibrosis and Secondary to Essential Thrombocythemia or Polycythemia Vera","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients diagnosed with Primary Myelofibrosis or secondary to Essential Thrombocythemia\u002FPolycythemia vera who are being treated or have been treated with ruxolitinib therapy in accordance with normal clinical practice.\n* Availability of data on clinical history prior to initiation of Ruxolitinib therapy\n* Obtaining informed consent for data collection and processing\n\nExclusion Criteria:\n\n* None",{"count":407,"type":21},1055,"10 Years","The study is observational multicenter retrospective and prospective cohort study of patients with primary or secondary myelofibrosis who have initiated therapy with ruxolitinib, prescribed as part of the normal course of care and completely independent of study participation. The primary purpose is to determine the impact of clinical and laboratory characteristics of myelofibrosis on the prognosis of patients treated with ruxolitinib, understood as long-term survival.",[31,25,26],[412,413],"Safety","Efficacy","2024-12-03",{"date":416,"type":36},"2024-12-05",{"date":418,"type":36},"2022-05-06",{"date":420,"type":21},"2032-05-31",{"name":422,"class":69},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",26,{"id":425,"slug":426,"hasResults":11,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":11,"sex":17,"minAge":431,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":293},"100521765","a-post-marketing-surveillance-study-to-assess-the-safety-of-fedratinib-in-korean-patients-with-myelofibrosis-100521765","NCT06073847","A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis","Inrebic® (Fedratinib) Post-Marketing Surveillance in Korean Patients With Myelofibrosis","Inclusion Criteria:\n\n* Participants 19 years of age or older\n* Participants who will receive fedratinib according to the approved label\n* For the first 2 years after marketing authorization, all participants who have received or are receiving fedratinib will also be registered\n* Participants who signed the informed consent form\n\nExclusion Criteria:\n\n* Participants who have been prescribed fedratinib for an indication not approved in Korea\n* Participants who have been prescribed fedratinib at a dose not approved in Korea\n* Participants for whom fedratinib is contraindicated as clarified in Korean prescribing information approved by the Ministry of Food and Drug Safety","19 Years",{"count":433,"type":21},137,"The purpose of this study is to assess the real-world safety of fedratinib for the treatment of adult participants with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (post-PV MF), or post essential thrombocythemia myelofibrosis (post-ET MF) who were previously treated with ruxolitinib. Participants will represent the overall patient population with PMF, post-PV MF or post-ET MF who lost adequate response to and\u002For are intolerant to ruxolitinib. Inadequate response definitions will follow Ministry of Food and Drug Safety-approved label and reimbursement criteria of the Health Insurance Review \\& Assessment Service.",[25,27,28],"2024-11-05",{"date":438,"type":36},"2024-11-06",{"date":440,"type":36},"2023-06-13",{"date":442,"type":21},"2027-12-20",{"name":444,"class":43},"Bristol-Myers Squibb",{"id":446,"slug":447,"hasResults":11,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":452,"targetDuration":408,"studyType":22,"phases":4,"briefSummary":454,"conditions":455,"keywords":463,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":44},"100267393","myeloproliferative-neoplasms-mpns-patient-registry-100267393","NCT02760238","Myeloproliferative Neoplasms (MPNs) Patient Registry","Clinical and Molecular Epidemiology of Myeloproliferative Neoplasms (MPNs)","Inclusion Criteria:\n\nDiagnosis of one of the following myeloproliferative neoplasms (MPNs):\n\n* Atypical CML (aCML)\n* Chronic eosinophilic leukemia-not otherwise specified (CEL, NOS),\n* Chronic myelomonocytic leukemia (CMML)\n* Chronic neutrophilic leukemia (CNL),\n* Essential thrombocythemia (ET),\n* Juvenile myelomonocytic leukemia (JMML),\n* Mastocytosis, MPN unclassifiable\n* MPN\u002FMDS unclassifiable,\n* Primary myelofibrosis (PMF),\n* Post-essential thrombocythemia myelofibrosis (post-ET MF),\n* Post-polycythemia vera MF (post-PV MF)\n* Refractory anemia with ringed sideroblasts associated with marked thrombocytosis (RARS-T)\n\nExclusion Criteria:\n\n* None",{"count":453,"type":21},5000,"The mandate of this MPN registry is to collect clinical information, including molecular results, from consenting patients with a variety of MPNs at different time points during the course of their disease.",[25,191,213,456,457,458,459,460,461,462],"Mastocytosis","Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative","Leukemia, Myelomonocytic, Juvenile","Chronic Eosinophilic Leukemia-not Otherwise Specified","Myelodysplastic-Myeloproliferative Diseases","Neoplasms","Leukemia, Myelomonocytic, Chronic",[464,465,466,467,468,469,461],"myeloproliferative neoplasm","myelodysplastic syndrome","registry","leukemia","Bone Marrow Diseases","Hematologic Diseases","2024-08-26",{"date":472,"type":36},"2024-08-27",{"date":474,"type":4},"2015-04",{"date":476,"type":21},"2027-10-31",{"name":478,"class":69},"University Health Network, Toronto",{"id":480,"slug":481,"hasResults":11,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":485,"eligibilityCriteria":486,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":487,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":489,"conditions":490,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":44},"100277897","myeloproliferative-neoplastic-diseases-observatory-from-brest-100277897","NCT02897297","Myeloproliferative Neoplastic Diseases Observatory From Brest","Observatoire Brestois Des Néoplasies Myéloprolifératives","OBENE","Inclusion Criteria:\n\n* Patients with essentiel thrombocythemia, polycythemia vera or primary myelofibrosis\n* Signature of the non-opposition consent form\n\nExclusion Criteria:\n\n* None",{"count":488,"type":21},1000,"All patients diagnosed or followed in Brest University Hospital for Philadelphia negative myeloproliferative neoplasms will be included in this observational study.\n\nMyeloproliferative neoplasms recorded included: polycythemia vera, essential Thrombocythemia and Primary Myelofibrosis.\n\nThis is a not interventional study. Alive patients need to sign a non-opposition consent form.\n\nPatients will be followed until last news (death, change of reference centre...).",[191,213,25],"2024-08-09",{"date":493,"type":36},"2024-08-12",{"date":495,"type":36},"2015-09-01",{"date":497,"type":21},"2025-09-30",{"name":499,"class":69},"University Hospital, Brest",{"id":501,"slug":502,"hasResults":11,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":4,"eligibilityCriteria":506,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":507,"targetDuration":4,"studyType":53,"phases":509,"briefSummary":510,"conditions":511,"keywords":514,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":44},"100532885","phase-1-pacritinib-w-talazoparib-in-pts-w-myeloproliferative-neoplasms-unresponsive-to-jak2-inhibition-100532885","NCT06218628","Pacritinib w\u002F Talazoparib in Pts w\u002F Myeloproliferative Neoplasms Unresponsive to JAK2 Inhibition","Phase I Study Accessing the Safety of Pacritinib in Combination With Talazoparib in Patients With Myeloproliferative Neoplasms Unresponsive to Frontline JAK2 (Janus Kinase 2) Inhibition","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed primary myelofibrosis (PMF), post-polycythemia vera-myelofibrosis (PPV-MF), post-essential thrombocythemia-myelofibrosis (PET-MF), chronic myelomonocytic leukemia, polycythemia vera, or essential thrombocytosis according to the 2008 World Health Organization criteria\n* Subject has at least 2 symptoms with a score ≥ 3 or a total score of ≥ 12, as measured by the MFSAF(Myelofibrosis Symptom Assessment Form) v4.0\n* Subject classified as intermediate-2 or high-risk MF, as defined by the Dynamic International Prognostic Scoring System Plus (DIPSS+70).\n* Age \\> 18 years.\n* ECOG (Eastern Cooperative Oncology Group) performance status 0-2\n* Subject must have received prior treatment with a single JAK2 inhibitor 4.1.6 for at least 12 weeks with documented disease progression OR subject must have appearance of new splenomegaly that is palpable to at least 5 cm below the left costal margin (LCM) in subjects with no evidence of splenomegaly prior to the initiation of any first line JAK2 inhibitor\n* Baseline QTc (corrected QT interval) \\\u003C0.47 seconds (Bazett formula)\n* Patients must have normal organ function as defined in protocol.\n* Ability to understand and willingness to sign a written informed consent and HIPAA consent document\n\nExclusion Criteria:\n\n* Patients may not be receiving any other investigational agents\n* Subjects must not be experiencing toxicity due to prior therapy that has not resolved to ≤Grade 1 by study registration, with the exception of sensory neuropathy related to previous systemic therapy exposure, alopecia and fatigue.\n* Patients that have transformed to Acute Myeloid Leukemia defined by \\>20% blasts count on peripheral blood smear or bone marrow biopsy evaluation\n* Uncontrolled inter-current illness including, but not limited to, any other malignancy (with the exception of hormonal therapy for breast cancer\u002Fprostate cancer in remission \\>1 year and for non-hormonal therapies for other cancers in remission for \\>3 years), other ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patients with history of hemorrhagic stroke and evidence of uncontrolled bleeding as well as bleeding disorder\n* Known HIV positive patients on combination antiretroviral therapy are ineligible because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.\n* Pregnant or breast-feeding.",{"count":508,"type":21},24,[55],"This is a prospective phase I dose-escalation study, with the primary objective to access the MTD and find the RP2D of talazoparib, given in combination with standard of care dosing of pacritinib.",[25,27,28,512,191,513],"Chronic Myelomonocytic Leukemia","Essential Thrombocytosis",[515,516,517,85],"Talazoparib","Pacritinib","JAK2 Inhibition","2024-05-02",{"date":520,"type":36},"2024-05-03",{"date":522,"type":36},"2024-04-05",{"date":524,"type":21},"2030-08-27",{"name":526,"class":69},"Fox Chase Cancer Center",{"id":528,"slug":529,"hasResults":11,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":534,"targetDuration":408,"studyType":22,"phases":4,"briefSummary":535,"conditions":536,"keywords":539,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":44},"100507083","asian-myeloproliferative-neoplasm-mpn-registry-100507083","NCT05882773","Asian Myeloproliferative Neoplasm (MPN) Registry","Asian Myeloproliferative Neoplasm (MPN) Registry - An Asian Myeloid Working Group (AMWG) Project.","Inclusion Criteria:\n\n1. Age ≥ 18 years old at the time of diagnosis of MPN.\n2. Subject was diagnosed with one of the following disorders according to the 2017 WHO classification (for patients diagnosed before 2017, the bone marrow reports will be re-evaluated according to the 2017 WHO classification):\n\n   1. Polycythaemia vera\n   2. Essential thrombocythemia\n   3. Primary myelofibrosis, pre-fibrotic\u002Fearly stage\n   4. Primary myelofibrosis, overt fibrotic stage\n   5. Post-polycythaemia vera myelofibrosis\n   6. Post-essential thrombocythaemia myelofibrosis\n   7. MPN-unclassifiable\n3. All subjects need to provide informed consent.\n\nExclusion Criteria:\n\nA subject will not be eligible if he\u002Fshe meets any of the following criteria:\n\n1\\. Subject was diagnosed with myelodysplastic syndrome, myelodysplastic syndrome\u002Fmyeloproliferative neoplasm, or chronic myeloid leukaemia BCR-ABL1 positive, under the 2017 WHO classification",{"count":488,"type":21},"This is a multinational, multicenter, prospective and retrospective, observational, cohort study of patients with myeloproliferative neoplasm.",[85,191,213,27,28,25,537,538],"Primary Myelofibrosis, Prefibrotic Stage","Primary Myelofibrosis, Fibrotic Stage",[540,541,542,543],"Myeloproliferative neoplasm","Epidemiology","Outcome","Prognostic factors","2023-05-21",{"date":546,"type":36},"2023-05-31",{"date":548,"type":21},"2023-05",{"date":550,"type":21},"2026-12",{"name":552,"class":69},"The University of Hong Kong",{"id":554,"slug":555,"hasResults":11,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":4,"eligibilityCriteria":559,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":560,"targetDuration":4,"studyType":53,"phases":561,"briefSummary":562,"conditions":563,"keywords":564,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":574},"100460813","phase-1-study-of-tl-895-combined-with-ruxolitinib-in-jaki-treatment-nave-mf-subjects-and-subjects-with-mf-who-have-a-suboptimal-response-to-ruxolitinib-100460813","NCT05280509","Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib","An Open-Label, Multicenter, Phase 1b\u002F2 Study of the Safety and Efficacy of TL-895 Combined With Ruxolitinib in Janus-associated Kinase Inhibitor (JAKi) Treatment-Naïve Myelofibrosis (MF) Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib","Inclusion Criteria:\n\nSubjects with suboptimal response to ruxolitinib:\n\n* Treatment with at a stable dose of ruxolitinib prior to study entry\n* Subjects ≥ 18 years of age and able to provide informed consent.\n* Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) criteria\n* High-risk, intermediate-2 risk, or intermediate-1 risk, defined by Dynamic International Prognostic System (DIPSS)\n* Palpable spleen measuring ≥ 5 cm below the left lower coastal margin (LLCM) or spleen volume of ≥ 450 cm3 by MRI or CT scan assessment\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* Adequate hematological, hepatic, \\& renal function.\n\nExclusion Criteria:\n\nTreatment-naive subjects:\n\n* Prior treatment with any JAKi\n\nSubjects with suboptimal response to ruxolitinib:\n\n* Documented disease progression while on ruxolitinib treatment\n\nAll subjects:\n\n* Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment\n* Prior treatment with a BTK or BMX inhibitor",{"count":278,"type":21},[55,56],"This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must have MF (PMF, Post PV MF, or Post ET MF) who are JAKi treatment-naïve or those who have a suboptimal response to ruxolitinib.",[31,25,307,308],[31],"2023-02-16",{"date":567,"type":36},"2023-02-21",{"date":569,"type":36},"2022-06-09",{"date":571,"type":21},"2027-04",{"name":573,"class":43},"Telios Pharma, Inc.",19]