[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100390926":3},{"organization":4,"armGroups":7,"interventions":33,"overallOfficials":211,"centralContacts":216,"locations":221,"responsibleParty":238,"collaborators":182,"id":240,"slug":241,"hasResults":242,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":182,"eligibilityCriteria":246,"healthyVolunteers":242,"sex":247,"minAge":248,"maxAge":249,"enrollmentInfo":250,"targetDuration":182,"studyType":253,"phases":254,"briefSummary":256,"conditions":257,"keywords":182,"overallStatus":223,"whyStopped":182,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":269},{"fullName":5,"class":6},"Fred Hutchinson Cancer Center","OTHER",[8,29],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort I (JAK inhibitor, conditioning, GVHD prophylaxis)","EXPERIMENTAL","JAK INHIBITOR THERAPY: Patients receive a JAK inhibitor at least 8 weeks prior to the start of HCT conditioning through day -4 before transplantation.\n\nCONDITIONING: Patients receive melphalan IV over 1 hour on day -5, fludarabine IV over 30-60 minutes on days -5 to -2, and undergo TBI on day -1 or day -1 and day 0.\n\nTRANSPLANT: Patients receive peripheral blood stem cell infusion on day 0.\n\nGVHD PROPHYLAXIS: Patients then receive cyclophosphamide IV over 3 hours on days 3-4, tacrolimus IV beginning day 5 then PO for about 6 months, mycophenolate mofetil PO BID or TID beginning day 5 for 6 weeks, and G-CSF SC beginning day 7 until neutrophil recovery is \\> 1,500\u002Fmm\\^3.\n\nAll patients undergo MRI, CT, bone marrow biopsy and aspiration and blood sample collection throughout the trial. Patients also undergo ECHO or MUGA on the trial.",[13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28],"Drug: Cyclophosphamide","Drug: JAK Inhibitor","Drug: Fludarabine","Biological: Recombinant Granulocyte Colony-Stimulating Factor","Drug: Melphalan","Drug: Mycophenolate Mofetil","Procedure: Peripheral Blood Stem Cell Transplantation","Drug: Tacrolimus","Radiation: Total-Body Irradiation","Procedure: Computed Tomography","Procedure: Magnetic Resonance Imaging","Procedure: Bone Marrow Biopsy","Procedure: Bone Marrow Aspiration","Procedure: Biospecimen Collection","Procedure: Echocardiography Test","Procedure: Multigated Acquisition Scan",{"label":30,"type":10,"description":31,"interventionNames":32},"Cohort II (JAK inhibitor, conditioning, GVHD prophylaxis)","JAK INHIBITOR THERAPY: Patients receive a JAK inhibitor at least 8 weeks prior to the start of HCT conditioning through day -4 before transplantation. Additionally, patients receive a JAK inhibitor following transplantation beginning day 5 through 9-12 months after transplant.\n\nCONDITIONING: Patients receive melphalan IV over 1 hour on day -5, fludarabine IV over 30-60 minutes on days -5 to -2, and undergo TBI on day -1 or day -1 and day 0.\n\nTRANSPLANT: Patients receive peripheral blood stem cell infusion on day 0.\n\nGVHD PROPHYLAXIS: Patients then receive cyclophosphamide IV over 3 hours on days 3-4, tacrolimus IV beginning day 5 then PO for about 6 months, mycophenolate mofetil PO BID or TID beginning day 5 for 6 weeks, and G-CSF SC beginning day 7 until neutrophil recovery is \\> 1,500\u002Fmm\\^3.\n\nAll patients undergo MRI, CT, bone marrow biopsy and aspiration and blood sample collection throughout the trial. Patients also undergo ECHO or MUGA on the trial.",[13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28],[34,77,86,91,100,117,123,134,146,158,166,173,179,183,189,195],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"DRUG","Cyclophosphamide","Given IV",[9,30],[40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76],"(-)-Cyclophosphamide","2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate","Carloxan","Ciclofosfamida","Ciclofosfamide","Cicloxal","Clafen","Claphene","CP monohydrate","CTX","CYCLO-cell","Cycloblastin","Cycloblastine","Cyclophospham","Cyclophosphamid monohydrate","Cyclophosphamide Monohydrate","Cyclophosphamidum","Cyclophosphan","Cyclophosphane","Cyclophosphanum","Cyclostin","Cyclostine","Cytophosphan","Cytophosphane","Cytoxan","Fosfaseron","Genoxal","Genuxal","Ledoxina","Mitoxan","Neosar","Revimmune","Syklofosfamid","WR- 138719","Asta B 518","B-518","WR-138719",{"type":35,"name":78,"description":79,"armGroupLabels":80,"otherNames":81},"JAK Inhibitor","Given PO",[9,30],[82,83,84,85],"JAK inhibitors","Janus Kinase Inhibitor","Ruxolitinib","Fedratinib",{"type":35,"name":87,"description":37,"armGroupLabels":88,"otherNames":89},"Fludarabine",[9,30],[90],"Fluradosa",{"type":92,"name":93,"description":94,"armGroupLabels":95,"otherNames":96},"BIOLOGICAL","Recombinant Granulocyte Colony-Stimulating Factor","Given SC",[9,30],[97,98,99],"Recombinant Colony-Stimulating Factor 3","rhG-CSF","143011-72-7",{"type":35,"name":101,"description":37,"armGroupLabels":102,"otherNames":103},"Melphalan",[9,30],[104,105,106,107,108,109,110,111,112,113,114,115,116],"Alanine Nitrogen Mustard","CB-3025","L-PAM","L-Phenylalanine mustard","L-sarcolysin","L-Sarcolysin Phenylalanine mustard","L-Sarcolysine","Melphalanum","Phenylalanine Mustard","Phenylalanine Nitrogen Mustard","Sarcoclorin","Sarkolysin","WR-19813",{"type":35,"name":118,"description":79,"armGroupLabels":119,"otherNames":120},"Mycophenolate Mofetil",[9,30],[121,122],"Cellcept","MMF",{"type":124,"name":125,"description":37,"armGroupLabels":126,"otherNames":127},"PROCEDURE","Peripheral Blood Stem Cell Transplantation",[9,30],[128,129,130,131,132,133],"PBPC transplantation","PBSCT","Peripheral Blood Progenitor Cell Transplantation","peripheral stem cell support","Peripheral Stem Cell Transplant","peripheral stem cell transplantation",{"type":35,"name":135,"description":136,"armGroupLabels":137,"otherNames":138},"Tacrolimus","Given IV and PO",[9,30],[139,140,141,142,143,144,145],"FK 506","Fujimycin","Hecoria","Prograf","Protopic","FK-506","Tacforius",{"type":147,"name":148,"description":149,"armGroupLabels":150,"otherNames":151},"RADIATION","Total-Body Irradiation","Undergo TBI",[9,30],[152,153,154,155,156,157],"TBI","Total Body Irradiation","Whole Body Irradiation","Whole-Body Irradiation","Total-Body Irradiation Prior to Stem Cell Transplant","SCT_TBI",{"type":124,"name":159,"description":160,"armGroupLabels":161,"otherNames":162},"Computed Tomography","Undergo CT",[9,30],[163,164,165],"CAT Scan","Computed Axial Tomography","CT SCAN",{"type":124,"name":167,"description":168,"armGroupLabels":169,"otherNames":170},"Magnetic Resonance Imaging","Undergo MRI",[9,30],[171,172],"MR Imaging","MRI",{"type":124,"name":174,"description":175,"armGroupLabels":176,"otherNames":177},"Bone Marrow Biopsy","Undergo bone marrow biopsy and aspiration",[9,30],[178],"Biopsy of Bone Marrow",{"type":124,"name":180,"description":175,"armGroupLabels":181,"otherNames":182},"Bone Marrow Aspiration",[9,30],null,{"type":124,"name":184,"description":185,"armGroupLabels":186,"otherNames":187},"Biospecimen Collection","Undergo blood sample collection",[9,30],[188],"Biological Sample Collection",{"type":124,"name":190,"description":191,"armGroupLabels":192,"otherNames":193},"Echocardiography Test","Undergo ECHO",[9,30],[194],"EC",{"type":124,"name":196,"description":197,"armGroupLabels":198,"otherNames":199},"Multigated Acquisition Scan","Undergo MUGA",[9,30],[200,201,202,203,204,205,206,207,208,209,210],"Blood Pool Scan","Equilibrium Radionuclide Angiography","Gated Blood Pool Imaging","Gated Heart Pool Scan","MUGA","MUGA Scan","Multi-Gated Acquisition Scan","Radionuclide Ventriculogram Scan","RNVG","SYMA Scanning","Synchronized Multigated Acquisition Scanning",[212],{"name":213,"affiliation":214,"role":215},"Rachel B. Salit","Fred Hutch\u002FUniversity of Washington Cancer Consortium","PRINCIPAL_INVESTIGATOR",[217],{"name":213,"role":218,"phone":219,"phoneExt":182,"email":220},"CONTACT","206-667-1317","rsalit@fredhutch.org",[222],{"facility":214,"status":223,"city":224,"state":225,"zip":226,"country":227,"countryCode":228,"cosmosGeoPoint":229,"geoPoint":234,"contacts":235},"RECRUITING","Seattle","Washington","98109","United States","US",{"type":230,"coordinates":231},"Point",[232,233],-122.33207,47.60621,{"lat":233,"lon":232},[236,237],{"name":213,"role":218,"phone":219,"phoneExt":182,"email":220},{"name":213,"role":215,"phone":182,"phoneExt":182,"email":182},{"type":239,"investigatorFullName":182,"investigatorTitle":182,"investigatorAffiliation":182,"oldNameTitle":182,"oldOrganization":182},"SPONSOR","100390926","phase-2-reduced-intensity-haploidentical-transplantation-for-the-treatment-of-primary-or-secondary-myelofibrosis-100390926",false,"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","ALL","18 Years","70 Years",{"count":251,"type":252},20,"ESTIMATED","INTERVENTIONAL",[255],"PHASE2","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.",[258,259],"Primary Myelofibrosis","Secondary Myelofibrosis","2026-01-08",{"date":262,"type":263},"2026-01-12","ACTUAL",{"date":265,"type":263},"2021-02-09",{"date":267,"type":252},"2029-08-31",{"name":5,"class":6},1]