[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636783":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":65,"centralContacts":69,"locations":75,"responsibleParty":117,"collaborators":37,"id":119,"slug":120,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":37,"eligibilityCriteria":125,"healthyVolunteers":121,"sex":126,"minAge":127,"maxAge":37,"enrollmentInfo":128,"targetDuration":37,"studyType":131,"phases":132,"briefSummary":135,"conditions":136,"keywords":37,"overallStatus":78,"whyStopped":37,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8,21,25],{"label":9,"type":10,"description":11,"interventionNames":12},"MK-1045 Dose Regimen A","EXPERIMENTAL","Participants will receive a lower MK-1045 dose once weekly for up to 13 cycles (two 28-day and eleven 42-day cycles). Participants will have the option to change treatment at the end of Part 1.",[13,14,15,16,17,18,19,20],"Biological: MK-1045","Drug: Acetaminophen","Drug: Diphenhydramine","Drug: Dexamethasone","Drug: Tocilizumab","Drug: Siltuximab","Drug: Avtozma","Drug: Tyenne",{"label":22,"type":10,"description":23,"interventionNames":24},"MK-1045 Dose Regimen B","Participants will receive a larger MK-1045 dose once weekly for up to 13 cycles (two 28-day and eleven 42-day cycles). Participants will have the option to change treatment at the end of Part 1.",[13,14,15,16,17,18,19,20],{"label":26,"type":27,"description":28,"interventionNames":29},"Blinatumomab","ACTIVE_COMPARATOR","Participants will receive blinatumomab on days 1, 8, 15, and 22 of each 42-day cycle",[30,16,17,18,19,20],"Biological: Blinatumomab",[32,38,40,45,49,52,56,59,62],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"BIOLOGICAL","MK-1045","Intravenous administration",[9,22],null,{"type":33,"name":26,"description":35,"armGroupLabels":39,"otherNames":37},[26],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":37},"DRUG","Acetaminophen","Oral administration as a premedication",[9,22],{"type":41,"name":46,"description":47,"armGroupLabels":48,"otherNames":37},"Diphenhydramine","Intravenous administration as a premedication",[9,22],{"type":41,"name":50,"description":47,"armGroupLabels":51,"otherNames":37},"Dexamethasone",[26,9,22],{"type":41,"name":53,"description":54,"armGroupLabels":55,"otherNames":37},"Tocilizumab","Intravenous administration as a rescue medication",[26,9,22],{"type":41,"name":57,"description":54,"armGroupLabels":58,"otherNames":37},"Siltuximab",[26,9,22],{"type":41,"name":60,"description":54,"armGroupLabels":61,"otherNames":37},"Avtozma",[26,9,22],{"type":41,"name":63,"description":54,"armGroupLabels":64,"otherNames":37},"Tyenne",[26,9,22],[66],{"name":67,"affiliation":5,"role":68},"Medical Director","STUDY_DIRECTOR",[70],{"name":71,"role":72,"phone":73,"phoneExt":37,"email":74},"Toll Free Number","CONTACT","1-888-577-8839","Trialsites@msd.com",[76,93,105],{"facility":77,"status":78,"city":79,"state":37,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Rambam Health Care Campus ( Site 0903)","RECRUITING","Haifa","3109601","Israel","IL",{"type":84,"coordinates":85},"Point",[86,87],34.99928,32.81303,{"lat":87,"lon":86},[90],{"name":91,"role":72,"phone":92,"phoneExt":37,"email":37},"Study Coordinator","+97247772547",{"facility":94,"status":78,"city":95,"state":37,"zip":96,"country":81,"countryCode":82,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Haddasah Medical Center ( Site 0900)","Jerusalem","9112001",{"type":84,"coordinates":98},[99,100],35.21633,31.76904,{"lat":100,"lon":99},[103],{"name":91,"role":72,"phone":104,"phoneExt":37,"email":37},"97226777333",{"facility":106,"status":78,"city":107,"state":37,"zip":108,"country":81,"countryCode":82,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Sheba Medical Center ( Site 0902)","Ramat Gan","5265601",{"type":84,"coordinates":110},[111,112],34.81065,32.08227,{"lat":112,"lon":111},[115],{"name":91,"role":72,"phone":116,"phoneExt":37,"email":37},"+97235308401",{"type":118,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100636783","phase-2-a-clinical-trial-of-mk-1045-in-people-with-b-cell-acute-lymphoblastic-leukemia-mk-1045-005-100636783",false,"NCT07570173","A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)","A Phase 2\u002F3, Randomized, Open-Label, Comparison Study of MK-1045 Versus Blinatumomab in Participants With Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)","Inclusion Criteria:\n\n* Has a confirmed diagnosis of relapsed\u002Frefractory (R\u002FR) B-precursor acute lymphoblastic leukemia (ALL) with 5% or more lymphoblasts in the bone marrow\n* Has CD19+ disease, confirmed by local flow cytometry and\u002For immunohistochemistry testing at the time of enrollment\n* Has Philadelphia-negative disease, confirmed by testing, at the time of enrollment\n* Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)\n\nExclusion Criteria:\n\n* Has Burkitt's leukemia\n* History or presence of clinically relevant central nervous system (CNS) diseases such as epilepsy, hemorrhagic\u002Fischemic stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, and psychosis\n* Has active acute graft versus host disease (GvHD) or chronic GvHD. NOTE: Participants who have received CNI for GvHD within 4 weeks before the first dose of study intervention are also excluded\n* History of serious cardiovascular and cerebrovascular diseases.\n* HIV-infection with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Received prior treatment with blinatumomab within 12 weeks for Part 1 and 24 weeks for Part 2 before the first dose of study intervention (individuals known to be refractory or intolerant to blinatumomab are to be excluded). Refractory to blinatumomab is defined as failure to achieve a response after at least 2 cycles of previous blinatumomab treatment\n* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention\n* Known additional malignancy that is progressing or has required active treatment within the past 2 years\n* Isolated extramedullary disease (EMD)\n* Active autoimmune disease unrelated to ALL that has required systemic treatment in the past 2 years or history of autoimmune disease with potential CNS involvement\n* Active infection requiring systemic therapy\n* Has not adequately recovered from major surgery or have ongoing surgical complications","ALL","12 Years",{"count":129,"type":130},340,"ESTIMATED","INTERVENTIONAL",[133,134],"PHASE2","PHASE3","Researchers are looking for new ways to treat people with relapsed or refractory B-cell acute lymphoblastic leukemia (R\u002FR B-ALL) that is CD19 positive using a medicine called MK-1045. MK-1045 is an immunotherapy, which is a treatment that helps the immune system fight cancer. This trial will compare MK-1045 to a standard immunotherapy called blinatumomab. The goals of this trial are to learn if more people who receive MK-1045 have no cancer cells in their bone marrow compared to people who receive blinatumomab and if people who receive MK-1045 live longer compared to people who receive blinatumomab.",[137],"B-cell Acute Lymphoblastic Leukemia","2026-06-03",{"date":140,"type":141},"2026-06-05","ACTUAL",{"date":143,"type":141},"2026-05-18",{"date":145,"type":130},"2033-10-18",{"name":5,"class":6},3]