[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636783":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":63,"studyPopulation":53,"armGroups":64,"interventions":88,"overallOfficials":121,"centralContacts":125,"locations":131,"responsibleParty":371,"collaborators":53,"id":373,"slug":374,"hasResults":375,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":53,"eligibilityCriteria":379,"healthyVolunteers":375,"sex":380,"minAge":381,"maxAge":53,"enrollmentInfo":382,"targetDuration":53,"studyType":385,"phases":386,"briefSummary":389,"conditions":390,"keywords":53,"overallStatus":134,"whyStopped":53,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":401},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":53},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Percentage of Participants with Complete Remission (CR) in Study Part 1 and Part 2","CR is defined as:\n\n* No circulating lymphoblasts\n* Extramedullary disease negative\n* Trilineage hematopoiesis (TLH) and \\\u003C5% leukemic blasts\n* Absolute neutrophil count (ANC) ≥1000\u002FμL\n* Platelets ≥100,000\u002FμL\n* No platelet transfusions in the last 7 days\n* No administration of short-acting granulocyte colony-stimulating factor (G-CSF) and long-acting G-CSF in the last 3 and 14 days, respectively","3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm)",{"measure":14,"description":15,"timeFrame":12},"Percentage of Participants Who Experience an Adverse Event (AE) in Study Part 1","An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with at least 1 AE will be presented.",{"measure":17,"description":18,"timeFrame":12},"Percentage of Participants Who Discontinue Study Intervention Due to an AE in Study Part 1","An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study intervention due to an AE will be presented.",{"measure":20,"description":21,"timeFrame":22},"Overall Survival (OS) in Study Part 2","OS is the time from randomization to death due to any cause.","Up to approximately 7 years",[24,26,29,32,35,38,41,43,46,49,51],{"measure":25,"description":21,"timeFrame":22},"Overall survival (OS) in Study Part 1",{"measure":27,"description":28,"timeFrame":12},"Percentage of Participants that achieve Minimal Residual Disease (MRD) in Study Part 1 and Part 2","MRD is defined as no detectable leukemia cells below a threshold of at least 10\\^-4.",{"measure":30,"description":31,"timeFrame":12},"Percentage of Participants that achieve CR\u002FCR with partial hematologic recovery (CRh)\u002FCR with incomplete count recovery (CRi) in Study Part 1 and Part 2","For participants who demonstrate CR or CRh or CRi, duration of remission is defined as the time from the first documented evidence of CR or CRh or CRi (whichever is earlier) until disease progression, relapse, or death due to any cause, whichever occurs first.\n\nCR is defined as:\n\n* No circulating lymphoblasts\n* Extramedullary disease negative\n* Trilineage hematopoiesis (TLH) and \\\u003C5% leukemic blasts\n* Absolute neutrophil count (ANC) ≥1000\u002FμL\n* Platelets ≥100,000\u002FμL\n* No platelet transfusions in the last 7 days\n* No administration of short-acting granulocyte colony-stimulating factor (G-CSF) and long-acting G-CSF in the last 3 and 14 days, respectively\n\nCRh is the same as CR but with less stringent requirements for platelet count (≥50,000\u002FμL) and ANC (≥500\u002FμL).\n\nCRi is the same as CR but without recovery of platelet count or without recovery of ANC (platelets \\\u003C100,000\u002FμL and ANC ≥1000\u002FμL or platelets ≥100,000\u002FμL and ANC \\\u003C1000\u002FμL.",{"measure":33,"description":34,"timeFrame":12},"Percentage of Participants with CR or CRh in Study Part 2","The percentage of participants who meet either CR or CRh requirements will be presented.\n\nCR is defined as:\n\n* No circulating lymphoblasts\n* Extramedullary disease negative\n* Trilineage hematopoiesis (TLH) and \\\u003C5% leukemic blasts\n* Absolute neutrophil count (ANC) ≥1000\u002FμL\n* Platelets ≥100,000\u002FμL\n* No platelet transfusions in the last 7 days\n* No administration of short-acting granulocyte colony-stimulating factor (G-CSF) and long-acting G-CSF in the last 3 and 14 days, respectively\n\nCRh is the same as CR but with less stringent requirements for platelet count (≥50,000\u002FμL) and ANC (≥500\u002FμL).",{"measure":36,"description":37,"timeFrame":22},"Duration of CR (DOR-CR) in Study Part 2","For participants who demonstrate CR, duration of remission is defined as the time from the first documented evidence of CR until disease progression, relapse, or death due to any cause, whichever occurs first.\n\nCR is defined as:\n\n* No circulating lymphoblasts\n* Extramedullary disease negative\n* Trilineage hematopoiesis (TLH) and \\\u003C5% leukemic blasts\n* Absolute neutrophil count (ANC) ≥1000\u002FμL\n* Platelets ≥100,000\u002FμL\n* No platelet transfusions in the last 7 days\n* No administration of short-acting granulocyte colony-stimulating factor (G-CSF) and long-acting G-CSF in the last 3 and 14 days, respectively",{"measure":39,"description":40,"timeFrame":22},"Duration of CR\u002FCRh (DOR-CR\u002FCRh) in Study Part 2","For participants who demonstrate CR or CRh, duration of remission is defined as the time from the first documented evidence of CR or CRh (whichever is earlier) until disease progression, relapse, or death due to any cause, whichever occurs first.\n\nCR is defined as:\n\n* No circulating lymphoblasts\n* Extramedullary disease negative\n* Trilineage hematopoiesis (TLH) and \\\u003C5% leukemic blasts\n* Absolute neutrophil count (ANC) ≥1000\u002FμL\n* Platelets ≥100,000\u002FμL\n* No platelet transfusions in the last 7 days\n* No administration of short-acting granulocyte colony-stimulating factor (G-CSF) and long-acting G-CSF in the last 3 and 14 days, respectively\n\nCRh is the same as CR but with less stringent requirements for platelet count (≥50,000\u002FμL) and ANC (≥500\u002FμL).",{"measure":42,"description":31,"timeFrame":22},"Duration of CR\u002FCRh\u002FCRi (DOR-CR\u002FCRh\u002FCRi) in Study Part 2",{"measure":44,"description":45,"timeFrame":22},"Event Free Survival (EFS) in Study Part 2","The time from randomization to the first documented disease progression, relapse, or death due to any cause, whichever occurs first.",{"measure":47,"description":48,"timeFrame":22},"Percentage of participants that proceed to allogeneic hematopoietic stem cell transplantation (allo-HSCT) in Study Part 2","The use of allo-HSCT treatment after randomization.",{"measure":50,"description":15,"timeFrame":22},"Percentage of Participants Who Experience an AE in Study Part 2",{"measure":52,"description":18,"timeFrame":22},"Percentage of Participants Who Discontinue Study Intervention Due to an AE in Study Part 2",null,{"allocation":55,"interventionModel":56,"interventionModelDescription":53,"primaryPurpose":57,"observationalModel":53,"timePerspective":53,"maskingInfo":58},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":59,"maskingDescription":60,"whoMasked":61},"SINGLE","Review of all disease response assessments in the Phase 3 component will be performed by an independent Clinical Adjudication Committee.\n\nReviewers will be blinded to treatment allocation and investigator assessment.",[62],"OUTCOMES_ASSESSOR","This study has 2 parts: Part 1 is a dose optimization phase of MK-1045. Part 2 is a randomized phase comparing the efficacy and safety of MK-1045 versus blinatumomab and will use the recommended dose of MK-1045 determined in Part 1",[65,78,82],{"label":66,"type":67,"description":68,"interventionNames":69},"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.",[70,71,72,73,74,75,76,77],"Biological: MK-1045","Drug: Acetaminophen","Drug: Diphenhydramine","Drug: Dexamethasone","Drug: Tocilizumab","Drug: Siltuximab","Drug: Avtozma","Drug: Tyenne",{"label":79,"type":67,"description":80,"interventionNames":81},"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.",[70,71,72,73,74,75,76,77],{"label":83,"type":84,"description":85,"interventionNames":86},"Blinatumomab","ACTIVE_COMPARATOR","Participants will receive blinatumomab on days 1, 8, 15, and 22 of each 42-day cycle",[87,73,74,75,76,77],"Biological: Blinatumomab",[89,94,96,101,105,108,112,115,118],{"type":90,"name":91,"description":92,"armGroupLabels":93,"otherNames":53},"BIOLOGICAL","MK-1045","Intravenous administration",[66,79],{"type":90,"name":83,"description":92,"armGroupLabels":95,"otherNames":53},[83],{"type":97,"name":98,"description":99,"armGroupLabels":100,"otherNames":53},"DRUG","Acetaminophen","Oral administration as a premedication",[66,79],{"type":97,"name":102,"description":103,"armGroupLabels":104,"otherNames":53},"Diphenhydramine","Intravenous administration as a premedication",[66,79],{"type":97,"name":106,"description":103,"armGroupLabels":107,"otherNames":53},"Dexamethasone",[83,66,79],{"type":97,"name":109,"description":110,"armGroupLabels":111,"otherNames":53},"Tocilizumab","Intravenous administration as a rescue medication",[83,66,79],{"type":97,"name":113,"description":110,"armGroupLabels":114,"otherNames":53},"Siltuximab",[83,66,79],{"type":97,"name":116,"description":110,"armGroupLabels":117,"otherNames":53},"Avtozma",[83,66,79],{"type":97,"name":119,"description":110,"armGroupLabels":120,"otherNames":53},"Tyenne",[83,66,79],[122],{"name":123,"affiliation":5,"role":124},"Medical Director","STUDY_DIRECTOR",[126],{"name":127,"role":128,"phone":129,"phoneExt":53,"email":130},"Toll Free Number","CONTACT","1-888-577-8839","Trialsites@msd.com",[132,150,158,171,186,195,207,221,233,245,257,272,282,294,304,317,332,344,356],{"facility":133,"status":134,"city":135,"state":136,"zip":137,"country":138,"countryCode":139,"cosmosGeoPoint":140,"geoPoint":145,"contacts":146},"Rigshospitalet ( Site 0802)","RECRUITING","Copenhagen","Capital Region","2100","Denmark","DK",{"type":141,"coordinates":142},"Point",[143,144],12.56553,55.67594,{"lat":144,"lon":143},[147],{"name":148,"role":128,"phone":149,"phoneExt":53,"email":53},"Study Coordinator","+45 35455375",{"facility":151,"status":134,"city":152,"state":153,"zip":154,"country":138,"countryCode":139,"cosmosGeoPoint":53,"geoPoint":53,"contacts":155},"Aarhus Universitetshospital. Hæmatologisk afdeling ( Site 0804)","Aarhus Nord","Central Jutland","8200",[156],{"name":148,"role":128,"phone":157,"phoneExt":53,"email":53},"+4578450000",{"facility":159,"status":134,"city":160,"state":161,"zip":162,"country":138,"countryCode":139,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Odense Universitetshospital ( Site 0801)","Odense","Region Syddanmark","5000",{"type":141,"coordinates":164},[165,166],10.38831,55.39594,{"lat":166,"lon":165},[169],{"name":148,"role":128,"phone":170,"phoneExt":53,"email":53},"+45 66113333",{"facility":172,"status":134,"city":173,"state":174,"zip":175,"country":176,"countryCode":177,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"Evangelismos General Hospital of Athens ( Site 5100)","Athens","Attica","106 76","Greece","GR",{"type":141,"coordinates":179},[180,181],23.72784,37.98376,{"lat":181,"lon":180},[184],{"name":148,"role":128,"phone":185,"phoneExt":53,"email":53},"00302132041",{"facility":187,"status":134,"city":173,"state":174,"zip":188,"country":176,"countryCode":177,"cosmosGeoPoint":189,"geoPoint":191,"contacts":192},"General Hospital of Athens \"Laiko\" ( Site 5101)","115 27",{"type":141,"coordinates":190},[180,181],{"lat":181,"lon":180},[193],{"name":148,"role":128,"phone":194,"phoneExt":53,"email":53},"+302132061702",{"facility":196,"status":134,"city":197,"state":53,"zip":198,"country":176,"countryCode":177,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"University Hospital of Ioannina ( Site 5103)","Ioannina","455 00",{"type":141,"coordinates":200},[201,202],20.85187,39.66341,{"lat":202,"lon":201},[205],{"name":148,"role":128,"phone":206,"phoneExt":53,"email":53},"+302651099656",{"facility":208,"status":134,"city":209,"state":53,"zip":210,"country":211,"countryCode":212,"cosmosGeoPoint":213,"geoPoint":217,"contacts":218},"Rambam Health Care Campus ( Site 0903)","Haifa","3109601","Israel","IL",{"type":141,"coordinates":214},[215,216],34.99928,32.81303,{"lat":216,"lon":215},[219],{"name":148,"role":128,"phone":220,"phoneExt":53,"email":53},"+97247772547",{"facility":222,"status":134,"city":223,"state":53,"zip":224,"country":211,"countryCode":212,"cosmosGeoPoint":225,"geoPoint":229,"contacts":230},"Haddasah Medical Center ( Site 0900)","Jerusalem","9112001",{"type":141,"coordinates":226},[227,228],35.21633,31.76904,{"lat":228,"lon":227},[231],{"name":148,"role":128,"phone":232,"phoneExt":53,"email":53},"97226777333",{"facility":234,"status":134,"city":235,"state":53,"zip":236,"country":211,"countryCode":212,"cosmosGeoPoint":237,"geoPoint":241,"contacts":242},"Sheba Medical Center ( Site 0902)","Ramat Gan","5265601",{"type":141,"coordinates":238},[239,240],34.81065,32.08227,{"lat":240,"lon":239},[243],{"name":148,"role":128,"phone":244,"phoneExt":53,"email":53},"+97235308401",{"facility":246,"status":134,"city":247,"state":53,"zip":248,"country":211,"countryCode":212,"cosmosGeoPoint":249,"geoPoint":253,"contacts":254},"Sourasky Medical Center. ( Site 0904)","Tel Aviv","6423906",{"type":141,"coordinates":250},[251,252],34.78057,32.08088,{"lat":252,"lon":251},[255],{"name":148,"role":128,"phone":256,"phoneExt":53,"email":53},"+97237772647",{"facility":258,"status":134,"city":259,"state":260,"zip":261,"country":262,"countryCode":263,"cosmosGeoPoint":264,"geoPoint":268,"contacts":269},"Policlinico Universitario Agostino Gemelli ( Site 1003)","Rome","Roma","00168","Italy","IT",{"type":141,"coordinates":265},[266,267],12.51133,41.89193,{"lat":267,"lon":266},[270],{"name":148,"role":128,"phone":271,"phoneExt":53,"email":53},"00390630154968",{"facility":273,"status":134,"city":274,"state":275,"zip":276,"country":277,"countryCode":278,"cosmosGeoPoint":53,"geoPoint":53,"contacts":279},"Tokyo Metropolitan Komagome Hospital ( Site 2106)","Bunkyo","Tokyo","113-8677","Japan","JP",[280],{"name":148,"role":128,"phone":281,"phoneExt":53,"email":53},"+81-3-3823-2101",{"facility":283,"status":134,"city":284,"state":275,"zip":285,"country":277,"countryCode":278,"cosmosGeoPoint":286,"geoPoint":290,"contacts":291},"Toranomon Hospital ( Site 2101)","Minato","105-8470",{"type":141,"coordinates":287},[288,289],139.7515,35.6581,{"lat":289,"lon":288},[292],{"name":148,"role":128,"phone":293,"phoneExt":53,"email":53},"+81-3-3588-1111",{"facility":295,"status":134,"city":296,"state":297,"zip":298,"country":299,"countryCode":300,"cosmosGeoPoint":53,"geoPoint":53,"contacts":301},"Radboud UMC ( Site 2003)","Geert Grooteplein-Zuid 8","Gelderland","6500 HB","Netherlands","NL",[302],{"name":148,"role":128,"phone":303,"phoneExt":53,"email":53},"0243618800",{"facility":305,"status":134,"city":306,"state":307,"zip":308,"country":299,"countryCode":300,"cosmosGeoPoint":309,"geoPoint":313,"contacts":314},"Amsterdam UMC ( Site 2001)","Amsterdam","North Holland","1081 HV",{"type":141,"coordinates":310},[311,312],4.88969,52.37403,{"lat":312,"lon":311},[315],{"name":148,"role":128,"phone":316,"phoneExt":53,"email":53},"+31204443628",{"facility":318,"status":134,"city":319,"state":320,"zip":321,"country":322,"countryCode":323,"cosmosGeoPoint":324,"geoPoint":328,"contacts":329},"Institut Català d'Oncologia (ICO) - Badalona ( Site 3001)","Badalona","Barcelona","08916","Spain","ES",{"type":141,"coordinates":325},[326,327],2.24741,41.45004,{"lat":327,"lon":326},[330],{"name":148,"role":128,"phone":331,"phoneExt":53,"email":53},"+34934978387",{"facility":333,"status":134,"city":334,"state":53,"zip":335,"country":322,"countryCode":323,"cosmosGeoPoint":336,"geoPoint":340,"contacts":341},"HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 3009)","Madrid","28233",{"type":141,"coordinates":337},[338,339],-3.70256,40.4165,{"lat":339,"lon":338},[342],{"name":148,"role":128,"phone":343,"phoneExt":53,"email":53},"+34914521900",{"facility":345,"status":134,"city":346,"state":53,"zip":347,"country":322,"countryCode":323,"cosmosGeoPoint":348,"geoPoint":352,"contacts":353},"Hospital Universitario de Salamanca ( Site 3002)","Salamanca","37007",{"type":141,"coordinates":349},[350,351],-5.66388,40.96882,{"lat":351,"lon":350},[354],{"name":148,"role":128,"phone":355,"phoneExt":53,"email":53},"+34923291100",{"facility":357,"status":134,"city":358,"state":359,"zip":360,"country":361,"countryCode":362,"cosmosGeoPoint":363,"geoPoint":367,"contacts":368},"Karolinska Universitetssjukhuset ( Site 4002)","Stockholm","Stockholm County","171 76","Sweden","SE",{"type":141,"coordinates":364},[365,366],18.06871,59.32938,{"lat":366,"lon":365},[369],{"name":148,"role":128,"phone":370,"phoneExt":53,"email":53},"+46812379740",{"type":372,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"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":383,"type":384},340,"ESTIMATED","INTERVENTIONAL",[387,388],"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.",[391],"B-cell Acute Lymphoblastic Leukemia","2026-08-20",{"date":394,"type":395},"2026-08-24","ACTUAL",{"date":397,"type":395},"2026-05-18",{"date":399,"type":384},"2033-10-18",{"name":5,"class":6},19]