[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myeloproliferative-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myeloproliferative-neoplasms":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,74,98,124,147,170,192,213,319],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":54,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100309946","phase-2-myeloablative-allo-hsct-with-related-or-unrelated-donor-for-heme-disorders-100309946",false,"NCT03314974","Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders","Myeloablative Allogeneic Hematopoietic Cell Transplantation Using a Related or Unrelated Donor for the Treatment of Hematological Diseases","-Inclusion Criteria:\n\n* Age: ≤ 60 years of age\n* Performance Status: Karnofsky ≥ 70%, Lansky play score ≥ 70\n* Consent: Voluntary written consent (adult or legally authorized representative; or parental\u002Fguardian)\n* Adequate Organ Function:\n\n  * Renal: Creatinine \\\u003C2x upper limit of normal. Patients above this limit must have creatinine clearance ≥ 40 ml\u002Fmin\u002F1.73m2 as determined by an age-appropriate method, such as cystatin C GFR.\n  * Hepatic: Bilirubin, AST, alkaline phosphatase \\\u003C4 times the upper limit of institutional normal\n  * Pulmonary: Diffusion capacity of oxygen, corrected for hemoglobin, \\> 50% of predicted. For pediatric patients not able to undergo PFTs or diffusion testing: O2 sat of \\>95% on room air\n  * Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \\> 45%. For children not able to cooperate with MUGA or echocardiography, such should be clearly stated in the physician's documentation\n  * HIV Status: HIV infection with undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation\n\nOther Inclusion Criteria:\n\n* Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment.\n* Donor Availability: Patients considered for transplantation must have a sufficient graft as based on current criteria of the University of Minnesota Blood and Marrow Transplantation Program\n* Eligible Diseases and Status: Patients are eligible unless their treatment is to be guided by a higher priority protocol.\n* Acute Leukemias: Must be in remission by morphology (≤5% blasts). Also a small percentage of blasts that is equivocal between marrow regeneration vs. early relapse are acceptable provided there are no associated cytogenetic markers consistent with relapse.\n* Acute Myeloid Leukemia (AML) and related precursor neoplasms: 2nd or greater complete remission (CR); first complete remission (CR1) in patients \\> 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk.\n* Favorable risk AML is defined as having one of the following:\n\n  * t(8,21) without cKIT mutation\n  * inv(16) or t(16;16) without cKIT mutation\n  * Normal karyotype with mutated NPM1 and wild type FLT-ITD\n  * Normal karyotype with double mutated CEBPA\n  * Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation\n* Very high risk pediatric patients with AML: Patients \\\u003C21 years, however, are eligible with (M2 marrow) with \\\u003C 25% blasts in marrow after having failed one or more cycles of chemotherapy.\n* Acute lymphoblastic leukemia (ALL)\u002Flymphoma: second or greater CR; CR1 unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities; CR1 high-risk ALL.\n* High risk ALL is defined as having one of the following:\n\n  * Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1\n  * 30 years of age or older at diagnosis\n  * White blood cell counts of greater than 30,000\u002FmcL (B-ALL) or greater than 100,000\u002FmcL (T-ALL) at diagnosis\n  * CNS leukemia involvement during the course of disease\n  * Slow cytologic response (\\>10% lymphoblasts in bone marrow on Day 14 of induction therapy)\n  * Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy\n* Very high risk pediatric patients with ALL: patients \\\u003C21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieve a complete remission.\n* Chronic Myelogenous Leukemia excluding refractory blast crisis: To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to one or more tyrosine kinase inhibitors.\n* Plasma Cell Leukemia after initial therapy, in patients who have achieved at least a partial remission\n* Myeloproliferative Neoplasms\u002FMyelofibrosis, either primary as a result of polycythemia vera or essential thrombocythemia, with disease risk of intermediate or high-risk according to DIPSS criteria. Blasts must be \\\u003C10% by bone marrow aspirate morphology.\n* Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features. Blasts must be \\\u003C 10% by a representative bone marrow aspirate morphology.\n* Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL), Marginal Zone B-Cell Lymphoma or Follicular Lymphoma are eligible if there was disease progression\u002Frelapse within 12 of achieving a partial or complete remission. Patients who had remissions lasting \\> 12 months, are eligible after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm) should be considered for debulking chemotherapy before transplant.\n* Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia are eligible after initial therapy in CR1+ or PR1+.\n* Diffuse large Cell NHL \\> CR\u002F\\> PR: Patients in CR\u002FPR with initial short remission (\\\u003C6 months) are eligible, or those who have failed\u002For are not eligible for autologous transplant.\n* Lymphoblastic Lymphoma, Burkitt's Lymphoma, and other high-grade NHL after initial therapy if stage III\u002FIV in CR1\u002FPR1 or after progression if stage I\u002FII \\\u003C 1 year.\n* Multiple Myeloma beyond PR2: Patients with chromosome 13 abnormalities, first response lasting less than 6 months, or β-2 microglobulin \\> 3 mg\u002FL, may be considered for this protocol after initial therapy.\n* Juvenile myelomonocytic leukemia\n* Biphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias in first or subsequent CR.\n* MRD positive leukemia (AML, ALL or accelerated\u002Fblast phase CML). Selected patients in morphologic CR, but with positive immunophenotypic (flow cytometry) or molecular evidence of MRD may be eligible if recent chemotherapy has not resulted in MRD negative status.\n* Natural Killer Cell Malignancies\n* Acquired Bone Marrow Failure Syndromes except for Fanconi Anemia or Dyskeratosis Congenita\n* Other Leukemia Subtypes: A major effort in the field of hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee.\n\nExclusion Criteria:\n\n* Chemotherapy refractory large cell and high grade NHL (i.e., progressive disease after \\> 2 salvage regimens)\n* CML in blast crisis\n* Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy.\n* Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.\n* Active central nervous system malignancy\n* if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If \\>18 years old prior myeloablative allotransplant or autologous transplant\n* Active HIV infection or known HIV positive serology\n* active uncontrolled infection\n* Pregnant or breastfeeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.","ALL","60 Years",{"count":19,"type":20},300,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a Phase II study of allogeneic hematopoietic stem cell transplant (HCT) using a myeloablative preparative regimen (of either total body irradiation (TBI); or, fludarabine\u002Fbusulfan for patients unable to receive further radiation). followed by a post-transplant graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide (PTCy), tacrolimus (Tac), and mycophenolate mofetil (MMF).",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53],"Acute Leukemia","Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia","Lymphoma","Chronic Myelogenous Leukemia","Plasma Cell Leukemia","Myeloproliferative Neoplasms","Myelofibrosis","Myelodysplasia","Refractory Anemia","High Risk Anemia","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Marginal Zone B-Cell Lymphoma","Follicular Lymphoma","Lymphoplasmacytic Lymphoma","Mantle-Cell Lymphoma","Prolymphocytic Leukemia","Diffuse Large Cell Non Hodgkins Lymphoma","Lymphoblastic Lymphoma","Burkitt Lymphoma","High Grade Non-Hodgkin's Lymphoma, Adult","Multiple Myeloma","Juvenile Myelomonocytic Leukemia","Biphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias","MRD Positive Leukemia","Natural Killer Cell Malignancies","Acquired Bone Marrow Failure Syndromes",[55,16,56,57,58,59,60],"AML","MDS","NHL","CLL","CML","SLL","RECRUITING","2026-06-23",{"date":64,"type":65},"2026-06-25","ACTUAL",{"date":67,"type":65},"2018-03-30",{"date":69,"type":20},"2028-06-10",{"name":71,"class":72},"Masonic Cancer Center, University of Minnesota","OTHER",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":4},"100637839","phase-2-selinexor-monotherapy-for-cytoreduction-in-bcrabl1-negative-myeloproliferative-neoplasms-100637839","NCT07626021","Selinexor Monotherapy for Cytoreduction in BCR::ABL1-Negative Myeloproliferative Neoplasms","An Open-Label, Single-Arm Phase II Study of Selinexor Monotherapy for Cytoreduction in Patients With BCR::ABL1-Negative Myeloproliferative Neoplasms","Inclusion Criteria:\n\n* Aged 18 to 80 years at the time of informed consent.\n* Diagnosis of Philadelphia chromosome-negative myeloproliferative neoplasm, including polycythemia vera, essential thrombocythemia, or primary myelofibrosis, according to World Health Organization criteria.\n* Presence of an indication for cytoreductive therapy, including at least one of the following:\n* Extreme thrombocytosis, defined as platelet count \\>1500 x 10\\^9\u002FL.\n* Progressive leukocytosis, defined as white blood cell count \\>25 x 10\\^9\u002FL.\n* Symptomatic splenomegaly documented by imaging.\n* Severe disease-related symptoms, such as significant weight loss within the past 6 months.\n* Unwillingness or inability to tolerate standard cytoreductive therapies, such as hydroxyurea or interferon.\n* Eastern Cooperative Oncology Group performance status of 0 to 2.\n* Adequate organ function, including renal, hepatic, cardiac, and coagulation function, as determined by laboratory tests and clinical evaluation in the opinion of the investigator.\n* Adequate baseline hematologic function without recent transfusion or growth factor support.\n* Ability to comply with study procedures, visits, and assessments.\n* Ability to understand and willingness to sign a written informed consent form.\n* For women of childbearing potential, a negative pregnancy test before study entry.\n* For participants of reproductive potential, agreement to use effective contraception during the study and for at least 120 days after the last dose of study drug.\n\nExclusion Criteria:\n\n* Diagnosis of Philadelphia chromosome-positive myeloproliferative neoplasm or chronic myeloid leukemia.\n* Concurrent acute leukemia or other active hematologic malignancy.\n* Severe or uncontrolled comorbid condition, including but not limited to significant cardiac or pulmonary disease, decompensated liver disease, or end-stage renal disease.\n* Active uncontrolled bacterial, viral, or fungal infection.\n* Active gastrointestinal disorder associated with significant bleeding or impaired drug absorption.\n* Significant neurologic or psychiatric disorder that may interfere with study participation or compliance.\n* Known hypersensitivity to selinexor or any of its components.\n* Receipt of another investigational agent or participation in another interventional clinical trial within 4 weeks before enrollment.\n* Recent receipt of cytotoxic chemotherapy, radiotherapy, immunotherapy, or other cytoreductive treatment before study entry.\n* History of substance abuse, alcohol dependence, or illicit drug use that may interfere with adherence to study requirements.\n* Another active malignancy requiring systemic treatment.\n* Clinically significant bleeding disorder, severe coagulopathy, or requirement for long-term therapeutic anticoagulation.\n* Receipt of a live vaccine within 30 days before the first dose of study drug, or planned receipt of a live vaccine during the study.\n* Known active infection with human immunodeficiency virus or active viral hepatitis.\n* Estimated life expectancy of less than 12 weeks.\n* Inability to provide informed consent due to cognitive impairment or severe psychiatric illness.\n* Any condition that, in the investigator's judgment, would make the participant unsuitable for participation in this study.","18 Years","80 Years",{"count":84,"type":20},15,[23],"Myeloproliferative neoplasms are chronic blood cancers in which the bone marrow produces too many blood cells. Patients with Philadelphia chromosome-negative myeloproliferative neoplasms, including polycythemia vera, essential thrombocythemia, and primary myelofibrosis, may need treatment to reduce high blood cell counts, relieve disease-related symptoms, and lower the risk of complications. However, currently available cytoreductive treatments may be ineffective, poorly tolerated, or inconvenient for some patients.\n\nSelinexor is an oral selective inhibitor of nuclear export that has shown antitumor activity in several hematologic malignancies. This study will evaluate the effectiveness and safety of selinexor used alone as cytoreductive treatment in patients with Philadelphia chromosome-negative myeloproliferative neoplasms who have an indication for cytoreductive therapy.\n\nThis is a prospective, single-arm, open-label phase II study conducted at a single center. Eligible participants will receive oral selinexor, with dose adjustments based on tolerability and blood cell counts. Participants will be followed for treatment response, symptom improvement, and side effects for up to 6 months. The results of this study may help determine whether selinexor could provide a potential treatment option for patients with Philadelphia chromosome-negative myeloproliferative neoplasms who have limited cytoreductive therapy choices.",[32],"NOT_YET_RECRUITING","2026-05-29",{"date":91,"type":65},"2026-06-04",{"date":93,"type":20},"2026-07-01",{"date":95,"type":20},"2026-08-31",{"name":97,"class":72},"Zhongshan Hospital (Xiamen), Fudan University",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":109,"conditions":110,"keywords":111,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":123},"100626904","phase-1-study-of-inca036978-in-participants-with-myeloproliferative-neoplasms-100626904","NCT07441694","Study of INCA036978 in Participants With Myeloproliferative Neoplasms","A Phase 1, Open-Label, Multicenter Study of INCA036978 in Participants With Myeloproliferative Neoplasms","Inclusion Criteria:\n\n* Life expectancy \\> 6 months.\n* Willingness to undergo a pretreatment and limited on-study BM biopsies and aspirates (as appropriate to disease).\n* Participants with MF, PV and ET as defined in the protocol.\n\nExclusion Criteria:\n\n* Presence of any hematological malignancy other than MF, PV, or ET.\n* Malignancy within the last 3 years prior to enrollment.\n* Acute or chronic HBV, Active HCV or known HIV or tuberculosis infection.\n* Clinically significant or uncontrolled cardiac disease.\n* Has undergone any prior allogeneic stem-cell transplantation or such transplantation is planned in the next 6 months.\n* Laboratory values outside the Protocol-defined ranges.\n* Prior history of major bleeding or thrombosis within the last 3 months prior to study enrollment.\n* Presence of chronic or current active infectious disease requiring systemic treatment.\n* Treatment with an MPN-directed therapy (approved or investigational) within the per protocol threshold before the administration of study drug.\n* Prior radiation therapy within 28 days before the first dose of study treatment.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.",{"count":106,"type":20},218,[108],"PHASE1","This study will be conducted to determine the safety, tolerability, dose-limiting toxicity (DLT)s, and maximum tolerated dose (MTD) and\u002For recommended dose for expansion (RDE)s of INCA036978 administered as monotherapy and in combination with a standard disease-directed therapy.",[32],[32,33,112,113],"Essential thrombocythemia","Polycythemia Vera","2026-05-27",{"date":89,"type":65},{"date":117,"type":65},"2026-05-11",{"date":119,"type":20},"2030-05-24",{"name":121,"class":122},"Incyte Corporation","INDUSTRY",49,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":21,"phases":133,"briefSummary":134,"conditions":135,"keywords":136,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},"100540188","phase-1-a-study-to-evaluate-the-safety-tolerability-of-incb160058-in-participants-with-myeloproliferative-neoplasms-100540188","NCT06313593","A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms","A Phase 1, Open-Label, Multicenter Study of INCB160058 in Participants With Myeloproliferative Neoplasms","Inclusion Criteria:\n\n* Age ≥ 18 years\n* MF:\n\n  * Intermediate-1 or higher risk PMF, post-PV MF, or post-ET MF with evidence of minimum burden of disease based on splenomegaly, and for the monotherapy cohort, participants must have been previously treated with at least 1 JAK inhibitor for ≥ 12 weeks and resistant, refractory, intolerant to, or have lost response to JAK inhibitor treatment.\n  * For the MF SubOpt R cohort: Therapeutic regimen prior to enrollment as defined in the protocol and unlikely to benefit from further monotherapy in the opinion of the investigator.\n* PV: Confirmed diagnosis of PV and previously treated with at least 1 prior standard cytoreductive therapy and are resistant, refractory, intolerant to, or have lost response to treatment.\n* ET: Confirmed diagnosis of high-risk ET as defined in the protocol and previously treated with at least 1 prior standard cytoreductive therapy and are resistant, refractory, intolerant to, or have lost response to treatment.\n* Life expectancy \\> 6 months.\n* Willingness to undergo a pretreatment and regular on-study bone marrow biopsies and aspirations (as appropriate to disease).\n* Existing documentation of JAK2V617F mutation from a qualified local laboratory.\n\nExclusion Criteria:\n\n* Presence of a hematological malignancy requiring treatment, other than PMF, post-PV MF, post-ET MF, PV, or ET.\n* Prior history of major bleeding or thrombosis within the 3 months prior to study enrollment.\n* Participants with abnormal hematologic, hepatic, or renal function based on laboratory evaluation.\n* Has undergone prior allogenic or autologous stem-cell transplantation or allogenic stem-cell transplantation is planned\n* Active invasive malignancy.\n* Significant concurrent, uncontrolled medical condition.\n* Acute or chronic HBV, active HCV or known HIV.\n* Any prior MPN-directed therapy within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.\n* Participants undergoing treatment with G-CSF or GM-CSF, romiplostim, or eltrombopag at any time within 4 weeks before the first dose of study treatment.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.",{"count":132,"type":20},186,[108],"This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 in Participants With Myeloproliferative Neoplasms.",[32],[32,137,33],"INCB160058","2026-04-30",{"date":140,"type":65},"2026-05-04",{"date":142,"type":65},"2024-08-08",{"date":144,"type":20},"2028-10-09",{"name":121,"class":122},30,{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":21,"phases":156,"briefSummary":157,"conditions":158,"keywords":159,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},"100518704","phase-1-a-study-to-evaluate-inca033989-administered-as-a-monotherapy-or-in-combination-with-ruxolitinib-in-participants-with-myeloproliferative-neoplasms-100518704","NCT06034002","A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms","A Phase 1, Open-Label, Multicenter Study of INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms","Inclusion Criteria:\n\n* Life expectancy \\> 6 months.\n* Willingness to undergo a pretreatment and regular on-study BM biopsies and aspirates (as appropriate to disease).\n* Existing documentation from a qualified local laboratory of CALR exon-9 mutation.\n* Participants with MF or ET as defined in the protocol.\n\nExclusion Criteria:\n\n* Presence of any hematological malignancy other than ET, PMF, or post-ET MF.\n* Prior history of major bleeding, or thrombosis within the last 3 months prior to study enrollment.\n* Participants with laboratory values exceeding the protocol defined thresholds.\n* Has undergone any prior allogenic or autologous stem-cell transplantation or such transplantation is planned.\n* Active invasive malignancy over the previous 2 years.\n* History of clinically significant or uncontrolled cardiac disease.\n* Active or chronic HBV or active HCV or known history of HIV.\n* Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody, or hypomethylating agent used to treat the participant's disease, with the exception of ruxolitinib for TGBs only, within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.\n* Participants undergoing treatment with G-CSF, GM-CSF, or TPO-R agonists at any time within 4 weeks before the first dose of study treatment.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.",{"count":155,"type":20},290,[108],"This study is being conducted to evaluate the safety, tolerability, dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and\u002For recommended dose(s) for expansion (RDE) of INCA033989 administered as a Monotherapy or in Combination With Ruxolitinib in participants with myeloproliferative neoplasms.",[32],[32,33,112,160],"CALR mutation","2026-04-14",{"date":163,"type":65},"2026-04-17",{"date":165,"type":65},"2023-12-04",{"date":167,"type":20},"2028-10-29",{"name":121,"class":122},13,{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":21,"phases":179,"briefSummary":180,"conditions":181,"keywords":182,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":191},"100593567","phase-1-a-study-to-evaluate-inca035784-in-participants-with-myeloproliferative-neoplasms-100593567","NCT07008118","A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms","A Phase 1, Open-Label, Multicenter Study of INCA035784 in Participants With Myeloproliferative Neoplasms","Inclusion Criteria:\n\n* Age 18 years or older at the time of signing the ICF\n* ECOG performance status of 0 to 1 for the dose escalation (Part 1a) and 0 to 2 for the dose expansion (Part 1b)\n* Documented CALR exon-9 mutation\n* Confirmed diagnosis of MPN according to the 2022 ICC criteria:\n\n  * DIPSS+ intermediate-2\u002Fhigh-risk MF with prior JAKi, \\\u003C20% blasts, and measurable spleen\n  * High-risk ET with platelets \\>450×10⁹\u002FL\n* Resistant, refractory, intolerant, or has lost response to ≥1 prior line of therapy for MF and ≥2 prior lines for ET (unless only a single standard-of-care option is approved in the participating country)\n* No prior stem cell transplant and none planned within 6 months\n* Minimum Laboratory Requirements:\n\n  * Platelet count ≥50 × 10⁹\u002FL\n  * Absolute neutrophil count ≥1 × 10⁹\u002FL\n  * International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN), unless receiving vitamin K antagonists\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C2.5 × ULN\n  * Total bilirubin \\\u003C2 × ULN\n  * Estimated creatinine clearance \\>45 or \\>30 mL\u002Fmin (depending on study part)\n\nExclusion Criteria:\n\n* Major bleeding or thrombosis (e.g., stroke, DVT, PE) within the past 3 months\n* Active or high-risk HBV, HCV, or HIV infection, or other chronic active infections requiring systemic treatment\n* Active invasive cancer within the past 2 years, except certain early-stage or low-risk cancers (e.g., resected skin, cervical, thyroid, or prostate cancer)\n* Pregnant or unwilling to avoid pregnancy or fathering a child during the study and for a defined period after the last dose.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.",{"count":178,"type":20},120,[108],"This study is being conducted to evaluate the safety and tolerability of INCA035784 in participants with myeloproliferative neoplasms.",[32],[32,33,112,160],"2026-04-02",{"date":185,"type":65},"2026-04-06",{"date":187,"type":65},"2025-10-01",{"date":189,"type":20},"2029-12-14",{"name":121,"class":122},26,{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":21,"phases":199,"briefSummary":200,"conditions":201,"keywords":202,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":212},"100511201","phase-1-a-study-to-evaluate-inca033989-administered-as-a-monotherapy-or-in-combination-with-ruxolitinib-in-participants-with-myeloproliferative-neoplasms-100511201","NCT05936359","Inclusion Criteria:\n\n* Life expectancy \\> 6 months.\n* Willingness to undergo a pretreatment and regular on-study BM biopsies and aspirates (as appropriate to disease).\n* Existing documentation from a qualified local laboratory of CALR exon-9 mutation.\n* Participants with MF and ET as defined in the protocol.\n\nExclusion Criteria:\n\n* Presence of any hematological malignancy other than ET, PMF, or post-ET MF.\n* Active invasive malignancy over the previous 2 years.\n* Active HBV\u002FHCV, HIV.\n* History of clinically significant or uncontrolled cardiac disease.\n* Has undergone any prior allogenic or autologous stem-cell transplantation or such transplantation is planned.\n* Laboratory values outside the Protocol-defined ranges.\n* Participants undergoing treatment with G-CSF, GM-CSF, or TPO-R agonists at any time within 4 weeks before the first dose of study treatment.\n* Prior history of major bleeding, or thrombosis within the last 3 months prior to study enrollment.\n* Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody, or hypomethylating agent used to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.\n* For TGBs only: Undergoing treatment with a potent\u002Fstrong inhibitor or inducer of CYP 3A4\u002F5 within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment, or expected to receive such treatment during the study.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.",{"count":198,"type":20},225,[108],"This study is being conducted to evaluate the safety, tolerability, and dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and\u002For recommended dose(s) for expansion (RDE) of INCA033989 administered as a monotherapy or in combination with ruxolitinib in participants with myeloproliferative neoplasms.",[32],[32,203,33,112,160],"Ruxolitinib","2026-03-20",{"date":206,"type":65},"2026-03-24",{"date":208,"type":65},"2023-09-25",{"date":210,"type":20},"2028-02-29",{"name":121,"class":122},29,{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":222,"phases":4,"briefSummary":223,"conditions":224,"keywords":277,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":318},"100620792","mpn-progression-registry-observational-study-tracking-symptoms-treatments-and-disease-progression-in-people-with-myeloproliferative-neoplasms-mpns-100620792","NCT07362225","MPN PROGRESSion Registry: Observational Study Tracking Symptoms, Treatments, and Disease Progression in People With Myeloproliferative Neoplasms (MPNs)","The MPN PROGRESSion Registry: A Retrospective and Prospective Observational Study Collecting Patient-Reported Outcomes, Electronic Health Records, and Claims Data to Track Symptoms, Treatments, and Disease Progression in Individuals Diagnosed With Myeloproliferative Neoplasms (MPNs).","Inclusion Criteria:\n\n* Adults aged 18 years or older at the time of enrollment.\n* Confirmed diagnosis of a myeloproliferative neoplasm (MPN), including one or more of the following subtypes, according to WHO 2022 criteria, including patients originally diagnosed with one of these conditions but who have received one or more stem cell transplants (SCTs) or bone marrow transplants (BMTs):\n* Polycythemia vera (PV)\n* Essential thrombocythemia (ET)\n* Primary myelofibrosis (PMF)\n* Secondary myelofibrosis (post-ET or post-PV MF)\n* Pre-fibrotic primary myelofibrosis (pre-PMF)\n* Myeloproliferative neoplasm-unclassifiable (MPN-U)\n* Myeloproliferative neoplasm, accelerated phase (MPN-AP)\n* Myeloproliferative neoplasm, blast phase (MPN-BP)\n* Post-MPN acute myeloid leukemia (AML)\n* Myelodysplastic syndrome (MDS)\u002FMPN overlap syndrome\n* Myeloproliferative neoplasm, blast phase (MPN-BP)\n* Ability to provide informed consent electronically or through a legally authorized representative.\n* Willingness to share health information, including electronic health records (EHR), laboratory values, and survey responses.\n* Willingness to complete periodic patient-reported outcome (PRO) surveys and symptom tracking assessments.\n\nExclusion Criteria:\n\n* Individuals under 18 years of age.\n* Inability to provide informed consent, either directly or through a legally authorized representative.\n* Currently enrolled in an interventional clinical trial where participation would interfere with the ability to participate in this observational registry (based on investigator or sponsor judgment).\n* Any condition that, in the judgment of the study team, would make participation in the registry infeasible or unsafe.",{"count":221,"type":20},5000,"OBSERVATIONAL","The MPN PROGRESSion Registry is a multi-year, observational research study designed to improve understanding of myeloproliferative neoplasms (MPNs)-a group of rare, chronic blood cancers that include polycythemia vera (PV), essential thrombocythemia (ET), primary myelofibrosis (MF), pre-fibrotic primary myelofibrosis (pre-PMF), secondary myelofibrosis, myeloproliferative neoplasm-unclassifiable (MPN-U), MPN in accelerated phase (MPN-AP), and MPN in blast phase (MPN-BP), post-MPN Acute Myeloid Leukemia (AML), and MDS\u002FMPN overlap syndrome as defined above per WHO 2022 criteria, including patients originally diagnosed with one of these conditions but who have received one or more SCTs and\u002For BMTs . These conditions are characterized by abnormal blood cell production in the bone marrow and may lead to complications such as blood clots, bleeding, bone marrow fibrosis, and, in some cases, progression to acute leukemia.\n\nThe central hypothesis of the registry is that collecting and analyzing real-world, longitudinal data-including electronic health records (EHRs), laboratory values, treatments, and patient-reported outcomes (PROs)-from a diverse population of people living with MPNs will help identify patterns and predictors of disease progression, treatment response, quality of life, and long-term outcomes. These insights are intended to guide future research, inform clinical guidelines, and support improvements in patient care.\n\nThe registry is non-interventional and observational; participants do not receive investigational treatments, and all medical care continues under the supervision of their own physicians. Data collection includes EHRs, PRO surveys, patient-reported symptom and lab tracking, insurance claims, and, in the future, may include linkages with other relevant disease registries and datasets. Potential collaborations under consideration include those with the European LeukemiaNet (ELN) MPN Registry, the Mayo Clinic MPN Database, the Center for International Blood and Marrow Transplant Research (CIBMTR), the SEER Program, Harmony Alliance Foundation, and the National Cancer Database (NCDB).\n\nThe registry emphasizes the patient voice, incorporating lived experiences related to hallmark MPN symptoms such as fatigue, pruritus (itching), bone pain, night sweats, and social and emotional impacts. Participants will be followed for at least five years, with many enrolled for ten years or longer, to capture the natural history of disease and long-term outcomes. PRO surveys will be completed approximately every six months, and EHR data will be regularly reviewed to track changes in clinical status, treatment, and disease evolution.\n\nStatistical analyses will use descriptive and inferential methods to examine clinical characteristics, symptom burden, disease trajectories, and patient-centered outcomes. Planned subgroup analyses may compare differences across diagnoses, treatment approaches, demographics, or genomic factors. Analytic plans will be finalized during the course of the study and may evolve in response to emerging scientific questions.\n\nThe registry is open to adults (18 years or older) living in the United States who have been diagnosed with any of the included MPN subtypes and are willing to share health information and complete study surveys. Individuals currently enrolled in interventional clinical trials or unable to provide informed consent may be excluded. Participation is voluntary, and participants may withdraw from the study at any time without affecting their medical care.\n\nPrivacy and data security are core priorities. Participant data will be securely stored and managed in accordance with all applicable privacy laws and research regulations. No identifiable information will be shared with external parties without appropriate authorization. Oversight is provided by a Steering Committee and a Patient Engagement Advisory Committee (PEAC), ensuring rigorous scientific, ethical, and patient-centered governance.\n\nThe registry is sponsored by the MPN Research Foundation, a nonprofit organization advancing research and patient advocacy in myeloproliferative neoplasms (MPNs). Participants can contact the registry team at any time with questions and will receive periodic updates on study findings.\n\nThis study aims to address critical gaps in understanding the real-world experiences of people with MPNs-such as symptom burden over time, risk factors for progression, and how different treatments impact patient outcomes. Findings may inform clinical trial design, support biomarker discovery, and contribute to the development of updated treatment recommendations. The registry is committed to including participants from diverse backgrounds and clinical settings to ensure findings are broadly applicable across the MPN community. Summary results will be shared through scientific publications, presentations, and other dissemination efforts to advance MPN research and care globally.",[113,225,226,227,228,229,33,230,231,232,233,234,235,236,237,238,239,240,241,242,243,244,245,246,247,248,249,250,251,252,253,254,255,256,257,258,259,260,32,261,262,263,264,265,266,267,268,269,270,271,272,273,274,275,276],"ET (Essential Thrombocythemia)","Polycythemia Vera (PV)","Essential Thrombocythemia (ET)","Primary Myelofibrosis (MF)","Primary Myelofibrosis (PMF)","Myelofibrosis (MF)","Myelofibrosis, Primary","Myelofibrosis, Post ET","Myelofibrosis, Post PV","Myelofibrosis (PMF)","Myelofibrosis，MF","Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis","Myelofibrosis Due to and Following Polycythemia Vera","Myelofibrosis Transformation in Essential Thrombocythemia","Myelofibrosis With High Molecular Risk Mutations","MF","Secondary Myelofibrosis","Secondary Myelofibrosis in Myeloproliferative Disease","Secondary Myelofibrosis (Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis)","Post-Polycythemia Vera Myelofibrosis","Post-polycythemia Vera Myelofibrosis (PPV-MF)","Post-polycythemia Vera Myelofibrosis (Post-PV MF)","Post-polycythemia Vera Myelofibrosis(Post-PV MF)","Post-PV MF","Post-Essential Thrombocythemia Myelofibrosis","Post-essential Thrombocythemia Myelofibrosis (PET-MF)","Post-essential Thrombocythemia Myelofibrosis(Post-ET MF)","Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)","Post-ET MF","Pre-fibrotic Myelofibrosis","Myeloproliferative Disorder","Myeloproliferative Disorders","Myeloproliferative Disorders (MPD)","Myeloproliferative Neoplasms (MPNs)","Myeloproliferative Neoplasm(MPN)-Associated Myelofibrosis","Myeloproliferative Neoplasm With 10% Blasts or Higher","MPN","MPN (Myeloproliferative Neoplasms)","MPN-associated Myelofibrosis","Myeloproliferative Neoplasm, Unclassifiable","Myeloproliferative Neoplasm, Not Otherwise Specified","Accelerated Phase MPN","Accelerated Phase Myeloproliferative Neoplasm","Blast Phase MPN","Blast Phase Myeloproliferative Neoplasm","Thrombocythemia Myelofibrosis (PET-MF)","Thrombocythemia, Essential","Thrombocythemia, Hemorrhagic","Agnogenic Myeloid Metaplasia","Chronic Idiopathic Myelofibrosis","Idiopathic Myelofibrosis","MDS\u002FMPN Crossover Syndromes",[32,113,278,241,279,255,264,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294,295,296,297,298,299,300,301,302,303,304,305,306,307,308],"Essential Thrombocythemia","Pre-fibrotic Primary Myelofibrosis","Myeloproliferative Neoplasm, Accelerated Phase","Myeloproliferative Neoplasm, Blast Phase","Chronic Myeloproliferative Disease","Hematologic Neoplasms","Bone Marrow Neoplasms","Blood Cancer","Disease Progression","Biomarker Discovery","Patient-Reported Outcomes","Electronic Health Records","Real-World Evidence","Longitudinal Study","Observational Study","Registry Study","Natural History Study","Quality of Life","Rare Diseases","Chronic Hematologic Diseases","Risk Stratification","Symptom Burden","Medical Claims Data","Longitudinal Data Collection","Patient-Centered Research","Health Outcomes Research","Clinical Outcomes","Clinical Guidelines Development","Regulatory Science","Drug Development","Treatment Response","2026-01-15",{"date":311,"type":65},"2026-01-23",{"date":313,"type":65},"2025-09-26",{"date":315,"type":20},"2035-09-08",{"name":317,"class":72},"MPN Research Foundation",2,{"id":320,"slug":321,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":261,"eligibilityCriteria":325,"healthyVolunteers":326,"sex":16,"minAge":81,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":21,"phases":329,"briefSummary":330,"conditions":331,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":73},"100538526","phase-1-ivosidenib-and-ruxolitinib-in-patients-with-advanced-myeloproliferative-neoplasms-mpns-that-have-an-idh1-gene-mutation-100538526","NCT06291987","Ivosidenib and Ruxolitinib in Patients With Advanced Myeloproliferative Neoplasms (MPNs) That Have an IDH1 Gene Mutation","A Phase 1b Trial of Ivosidenib Combined With Ruxolitinib in IDH1-Mutated Advanced-Phase MPNs","Inclusion Criteria:\n\n* Advanced-Phase IDH1-mutated Ph-negative MPNs (both untreated and relapsed\u002Frefractory) including any of the following:\n\n  * polycythemia vera with (PV) ≥ 5% peripheral or bone marrow blasts at time of screening\n  * essential thrombocythemia (ET) with ≥ 5% peripheral or bone marrow blasts at time of screening\n  * primary myelofibrosis (PMF) with ≥ 5% peripheral or bone marrow blasts at time of screening\n  * Atypical CML with ≥ 5% peripheral or bone marrow blasts at time of screening\n  * MPN-NOS with ≥ 5% peripheral or bone marrow blasts at time of screening\n  * MDS\u002FMPN Overlap Syndromes including CMML with ≥ 5% peripheral or bone marrow blasts at time of screening\n  * post-PV myelofibrosis with ≥ 5% blasts peripheral or bone marrow blasts at time of screening\n  * post-ET myelofibrosis with ≥ 5% blasts peripheral or bone marrow blasts at time of screening\n  * primary and secondary myelofibrosis with inadequate response to JAK inhibitor regardless of blast percentage. Inadequate response to JAK inhibitor will be defined as lack of achieving any clinical improvement criteria within 12 weeks of of JAK inhibitor initiation.\n* Patients can be on cytoreduction at time of study enrollment with hydroxyurea or steroids.\n* Age ≥18 years.\n* ECOG performance status ≤2\n* Patients must have normal organ and marrow function as defined below:\n\n  * Creatinine clearance ≥60 mL\u002Fmin, determined by the Cockroft-Gault formula, OR serum creatinine ≤ 1.5 x ULN\n  * AST and ALT ≤3 x ULN and bilirubin ≤1.5 x ULN (unless considered due to Gilbert's syndrome, leukemic involvement, or extravascular hemolysis in the spleen)\n  * A platelet count of 50 x 109\u002FL should be met for those with chronic-phase myelofibrosis and \\\u003C 5% blasts peripherally or in bone marrow\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Other eligibility criteria include the following:\n\n  * Patients must be at least 4 weeks from major surgery, radiation therapy, or participation in other investigational trials, and must have recovered from clinically significant toxicities related to these prior treatments.\n  * The effects of the investigational agents 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.\n  * Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients cannot be on concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in this protocol. Patients cannot have had prior treatment with ivosidenib.\n* Patients with a \"currently active\" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a \"currently active\" malignancy if they have completed therapy and are free of disease or they are not currently requiring treatment for an indolent malignancy. Patients with APL and active CNS disease would also be excluded\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ivosidenib or ruxolitinib.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, venous thromboembolism, stroke, active chronic liver disease (eg chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cholangitis, hemochromatosis) or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Subject has QTc interval ≥ 450 msec or other factors that increase the risk of QT prolongation or arrhythmic events at screening unless due to bundle branch block or pacemaker with approval of the principal investigator.\n* Pregnant women are excluded from this study because ruxolitinib and ivosidenib carry the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ruxolitinib and ivosidenib, breastfeeding should be discontinued if the mother is treated with any of these agents.\n* Patient is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.\n* Patients receiving any medications or substances that are inhibitors or inducers of CYP3A4 should have eligibility and alternative medications reviewed by site PI.",true,{"count":328,"type":20},18,[108],"The purpose of this research is to gather information on the safety and effectiveness determining maximum tolerated dose (MTD) of ruxolitinib in combination with ivosidenib in IDH1-mutated advanced-phase Ph-negative MPNs while evaluate the efficacy of ruxolitinib in combination with ivosidenib in IDH1-mutated advanced-phase Ph-negative MPNs.",[32],"2025-11-03",{"date":334,"type":65},"2025-11-05",{"date":336,"type":65},"2024-09-19",{"date":338,"type":20},"2026-05",{"name":340,"class":72},"University of Chicago"]