[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641666":3},{"organization":4,"outcomesModule":7,"designInfo":74,"detailedDescription":73,"studyPopulation":73,"armGroups":82,"interventions":105,"overallOfficials":161,"centralContacts":165,"locations":171,"responsibleParty":589,"collaborators":73,"id":591,"slug":592,"hasResults":593,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":73,"eligibilityCriteria":597,"healthyVolunteers":593,"sex":598,"minAge":599,"maxAge":73,"enrollmentInfo":600,"targetDuration":73,"studyType":603,"phases":604,"briefSummary":607,"conditions":608,"keywords":73,"overallStatus":174,"whyStopped":73,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":619},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":28,"otherOutcomes":73},[9,13,16,20,24],{"measure":10,"description":11,"timeFrame":12},"Part 1: Number of Participants Who Experience an Adverse Event (AE)","An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.","Up to approximately 15 months",{"measure":14,"description":11,"timeFrame":15},"Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE","Up to approximately 12 months",{"measure":17,"description":18,"timeFrame":19},"Part 1: Number of Participants Who Experience Dose Limiting Toxicity (DLT)","DLT will be defined as any drug-related AE observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle.","Up to approximately 36 days",{"measure":21,"description":22,"timeFrame":23},"Part 1: Complete Response (CR) Rate","For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) per Lugano response criteria. CR rate is defined as the percentage of participants who experience a CR. The CR rate as assessed by physician investigator will be presented.","Up to approximately 60 months",{"measure":25,"description":26,"timeFrame":27},"Part 2: Progression-Free Survival (PFS)","PFS is defined as the time from randomization to the first documented disease progression per Lugano response criteria by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first.","Up to approximately 63 months",[29,32,35,39,42,45,49,52,55,58,61,63,65,69,71],{"measure":30,"description":31,"timeFrame":23},"Part 1: Objective Response Rate (ORR)","ORR is defined as the percentage of participants with CR (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Lugano response criteria. The percentage of participants who experience CR or PR as assessed by physician investigator will be presented.",{"measure":33,"description":34,"timeFrame":23},"Part 1: Duration of CR","For participants who demonstrate CR (CR: disappearance of all target lesions) at end of treatment per Lugano response criteria, defined as the time from the first documented evidence of CR until disease progression or death due to any cause, whichever occurs first.",{"measure":36,"description":37,"timeFrame":38},"Part 1: Area Under the Concentration-Time Curve at Steady State (AUCss) of MK-1045","Blood samples will be collected at multiple time points to estimate the AUCss of MK-1045.","Predose and at designated time points post-dose (up to approximately 12 months)",{"measure":40,"description":41,"timeFrame":38},"Part 1: Maximum Concentration (Cmax) of MK-1045","Blood samples will be collected at multiple time points to estimate the Cmax of MK-1045.",{"measure":43,"description":44,"timeFrame":38},"Part 1: Trough Concentration (Ctrough) of MK-1045","Blood samples will be collected at multiple time points to estimate the Ctrough of MK-1045.",{"measure":46,"description":47,"timeFrame":48},"Part 2: CR Rate at 30 Months","For participants who demonstrate a confirmed CR (CR: disappearance of all target lesions) per Lugano response criteria. CR rate is defined as the percentage of participants who experience a CR by month 30. The CR rate as assessed by BICR at month 30 will be presented.","30 months",{"measure":50,"description":51,"timeFrame":27},"Part 2: ORR","ORR is defined as the percentage of participants with CR (CR: disappearance of all target lesions) or PR (PR: at least a 30% decrease in the sum of diameters of target lesions) per Lugano response criteria. The percentage of participants who experience CR or PR as assessed by BICR will be presented.",{"measure":53,"description":54,"timeFrame":27},"Part 2: Overall Survival (OS)","OS is defined as the time from randomization to death due to any cause.",{"measure":56,"description":57,"timeFrame":27},"Part 2: Event-Free Survival (EFS)","EFS is defined as the time randomization to the first documented disease progression per Lugano response criteria by BICR, death due to any cause, initiation of a new anticancer therapy or a positive biopsy for residual disease, whichever occurs first.",{"measure":59,"description":60,"timeFrame":27},"Part 2: Duration of CR","For participants who demonstrate CR (CR: disappearance of all target lesions) per Lugano response criteria by BICR, defined as the time from the first documented evidence of CR until disease progression or death due to any cause, whichever occurs first.",{"measure":62,"description":11,"timeFrame":12},"Part 2: Number of Participants Who Experience an AE",{"measure":64,"description":11,"timeFrame":15},"Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE",{"measure":66,"description":67,"timeFrame":68},"Part 2: Change From Baseline in Health-Related Quality Of Life (HRQoL) on Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Trial Outcome Index (TOI)","The FACT-Lym is a 42-item questionnaire designed to measure HRQoL and cancer-specific symptoms in non-Hodgkin lymphoma patients. Subscales include FACT-General (FACT-G), FACT-Trial Outcome Index (FACT-TOI), FACT-Lym total score (FACT-Lym TS), and the Lymphoma subscale (Lym S). The Lym S has a single domain consisting of 15 items specific to lymphoma burden with a score ranging from 0 to 60. FACT-G has 4 well-being domains, physical (7 items), social\u002Ffamily (7), emotional (6), and functional (7), with scores ranging from 0 to 108. FACT-TOI combines FACT-G's physical and functional domains with Lym S, with scores ranging from 0 to 116. FACT-Lym TS combines FACT-G with Lym S, with scores ranging from 0 to 168. The scoring of FACT-Lym is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. The higher the score the better the quality of life.","Baseline and up to approximately month 13",{"measure":70,"description":67,"timeFrame":68},"Part 2: Change From Baseline in HRQoL on FACT-Lym Total Score",{"measure":72,"description":67,"timeFrame":68},"Part 2: Change From Baseline in HRQoL on FACT-Lym Physical Well-being (PWB) (Items General Physical [GP]1 Through GP7)",null,{"allocation":75,"interventionModel":76,"interventionModelDescription":73,"primaryPurpose":77,"observationalModel":73,"timePerspective":73,"maskingInfo":78},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":79,"maskingDescription":73,"whoMasked":80},"SINGLE",[81],"OUTCOMES_ASSESSOR",[83,91,95],{"label":84,"type":85,"description":86,"interventionNames":87},"Part 1: MK-1045 plus Rituximab (or biosimilar)","EXPERIMENTAL","Participants will receive escalating doses of MK-1045 (from 2 mg to 90 mg) once weekly (QW) for up to approximately 12 months. Participants will also receive 375 mg\u002Fm\\^2 rituximab (or biosimilar) once every 4 weeks (Q4W) for up to approximately 6 months.",[88,89,90],"Biological: MK-1045","Biological: Rituximab","Biological: Rituximab biosimilar",{"label":92,"type":85,"description":93,"interventionNames":94},"Part 2: MK-1045 plus Rituximab (or biosimilar)","Participants will receive MK-1045 QW at the dose determined in Part 1 for up to approximately 12 months. Participants will also receive 375 mg\u002Fm\\^2 rituximab (or biosimilar) Q4W for up to approximately 6 months.",[88,89,90],{"label":96,"type":85,"description":97,"interventionNames":98},"Part 2: Physician's Choice of Chemotherapy plus Rituximab (or biosimilar)","Participants will receive physician's choice of: 90 mg\u002Fm\\^2 bendamustine on Days 1 and 2 of each 4-week cycle for up to 6 cycles (up to approximately 6 months) plus 375 mg\u002Fm\\^2 rituximab (or biosimilar) Q4W for up to approximately 6 months OR 750 mg\u002Fm\\^2 cyclophosphamide, 50 mg\u002Fm\\^2 doxorubicin, and 1.4 mg\u002Fm\\^2 vincristine on day 1 of each 3-week cycle (Q3W) and 100 mg\u002Fm\\^2 prednisone (or prednisolone) once daily on days 1 through 5 Q3W for up to 6 cycles (up to approximately 4 months) plus 375 mg\u002Fm\\^2 rituximab (or biosimilar) Q3W for up to approximately 4 months OR 750 mg\u002Fm\\^2 cyclophosphamide and 1.4 mg\u002Fm\\^2 vincristine Q3W and 40 mg\u002Fday prednisone (or prednisolone) once daily on days 1 through 5 of each 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 375 mg\u002Fm\\^2 rituximab (or biosimilar) Q3W for up to approximately 6 months.",[89,90,99,100,101,102,103,104],"Drug: Bendamustine","Drug: Cyclophosphamide","Drug: Vincristine","Drug: Prednisone","Drug: Prednisolone","Drug: Doxorubicin Hydrochloride",[106,113,117,124,132,139,145,151,156],{"type":107,"name":108,"description":109,"armGroupLabels":110,"otherNames":111},"BIOLOGICAL","MK-1045","Intravenous (IV) infusion",[84,92],[112],"CN201",{"type":107,"name":114,"description":115,"armGroupLabels":116,"otherNames":73},"Rituximab","IV infusion",[84,92,96],{"type":107,"name":118,"description":115,"armGroupLabels":119,"otherNames":120},"Rituximab biosimilar",[84,92,96],[121,122,123],"TRUXIMA®","RUXIENCE®","RIABNI®",{"type":125,"name":126,"description":115,"armGroupLabels":127,"otherNames":128},"DRUG","Bendamustine",[96],[129,130,131],"Bendeka","Treanda","Belrapzo",{"type":125,"name":133,"description":115,"armGroupLabels":134,"otherNames":135},"Cyclophosphamide",[96],[136,137,138],"Cytoxan","Neosar","Cytophosphane",{"type":125,"name":140,"description":115,"armGroupLabels":141,"otherNames":142},"Vincristine",[96],[143,144],"Oncovin","Vincasar PFS",{"type":125,"name":146,"description":147,"armGroupLabels":148,"otherNames":149},"Prednisone","Per approved product label",[96],[150],"Prednisone acetate",{"type":125,"name":152,"description":147,"armGroupLabels":153,"otherNames":154},"Prednisolone",[96],[155],"Prednisolone acetate",{"type":125,"name":157,"description":115,"armGroupLabels":158,"otherNames":159},"Doxorubicin Hydrochloride",[96],[160],"Adriamycin",[162],{"name":163,"affiliation":5,"role":164},"Medical Director","STUDY_DIRECTOR",[166],{"name":167,"role":168,"phone":169,"phoneExt":73,"email":170},"Toll Free Number","CONTACT","1-888-577-8839","Trialsites@msd.com",[172,190,203,216,229,242,252,264,277,289,304,319,332,347,360,375,384,398,410,422,437,450,463,478,491,502,514,526,540,552,565,577],{"facility":173,"status":174,"city":175,"state":176,"zip":177,"country":178,"countryCode":179,"cosmosGeoPoint":180,"geoPoint":185,"contacts":186},"City of Hope - Duarte Cancer Center ( Site 1301)","RECRUITING","Duarte","California","91010","United States","US",{"type":181,"coordinates":182},"Point",[183,184],-117.97729,34.13945,{"lat":184,"lon":183},[187],{"name":188,"role":168,"phone":189,"phoneExt":73,"email":73},"Study Coordinator","877-589-4352",{"facility":191,"status":174,"city":192,"state":193,"zip":194,"country":178,"countryCode":179,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"University of Kentucky ( Site 1303)","Lexington","Kentucky","40536",{"type":181,"coordinates":196},[197,198],-84.47772,37.98869,{"lat":198,"lon":197},[201],{"name":188,"role":168,"phone":202,"phoneExt":73,"email":73},"859-323-2354",{"facility":204,"status":174,"city":205,"state":206,"zip":207,"country":178,"countryCode":179,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"John Theurer Cancer Center at Hackensack University Medical Center ( Site 1311)","Hackensack","New Jersey","07601",{"type":181,"coordinates":209},[210,211],-74.04347,40.88593,{"lat":211,"lon":210},[214],{"name":188,"role":168,"phone":215,"phoneExt":73,"email":73},"551-996-1777",{"facility":217,"status":174,"city":218,"state":219,"zip":220,"country":178,"countryCode":179,"cosmosGeoPoint":221,"geoPoint":225,"contacts":226},"Duke Cancer Center Clinic 1B\u002FC Onc\u002FHeme ( Site 1307)","Durham","North Carolina","27710",{"type":181,"coordinates":222},[223,224],-78.89862,35.99403,{"lat":224,"lon":223},[227],{"name":188,"role":168,"phone":228,"phoneExt":73,"email":73},"919-681-5698",{"facility":230,"status":174,"city":231,"state":232,"zip":233,"country":178,"countryCode":179,"cosmosGeoPoint":234,"geoPoint":238,"contacts":239},"SCRI Oncology Partners ( Site 7000)","Nashville","Tennessee","37203",{"type":181,"coordinates":235},[236,237],-86.78444,36.16589,{"lat":237,"lon":236},[240],{"name":188,"role":168,"phone":241,"phoneExt":73,"email":73},"615-329-7640",{"facility":243,"status":174,"city":244,"state":245,"zip":246,"country":247,"countryCode":248,"cosmosGeoPoint":73,"geoPoint":73,"contacts":249},"Instituto Alexander Fleming ( Site 0105)","Ciudad Autonoma de Buenos Aires","Buenos Aires","C1426ANZ","Argentina","AR",[250],{"name":188,"role":168,"phone":251,"phoneExt":73,"email":73},"+541132218900",{"facility":253,"status":174,"city":245,"state":254,"zip":255,"country":247,"countryCode":248,"cosmosGeoPoint":256,"geoPoint":260,"contacts":261},"Hospital Aleman ( Site 0101)","Buenos Aires F.D.","C1118AAT",{"type":181,"coordinates":257},[258,259],-58.37723,-34.61315,{"lat":259,"lon":258},[262],{"name":188,"role":168,"phone":263,"phoneExt":73,"email":73},"+54 11-4827-7000",{"facility":265,"status":174,"city":266,"state":267,"zip":268,"country":247,"countryCode":248,"cosmosGeoPoint":269,"geoPoint":273,"contacts":274},"Sanatorio Nuestra Senora del Rosario ( Site 0104)","Rosario","Santa Fe Province","S2001SBK",{"type":181,"coordinates":270},[271,272],-60.63932,-32.94682,{"lat":272,"lon":271},[275],{"name":188,"role":168,"phone":276,"phoneExt":73,"email":73},"+543414858585",{"facility":278,"status":174,"city":279,"state":73,"zip":280,"country":247,"countryCode":248,"cosmosGeoPoint":281,"geoPoint":285,"contacts":286},"Hospital Privado Universitario de Córdoba ( Site 0102)","Córdoba","X5016KEH",{"type":181,"coordinates":282},[283,284],-64.18853,-31.40648,{"lat":284,"lon":283},[287],{"name":188,"role":168,"phone":288,"phoneExt":73,"email":73},"+54 9 0351 468-8200",{"facility":290,"status":174,"city":291,"state":292,"zip":293,"country":294,"countryCode":295,"cosmosGeoPoint":296,"geoPoint":300,"contacts":301},"Box Hill Hospital ( Site 0201)","Box Hill","Victoria","3128","Australia","AU",{"type":181,"coordinates":297},[298,299],145.12545,-37.81887,{"lat":299,"lon":298},[302],{"name":188,"role":168,"phone":303,"phoneExt":73,"email":73},"+6104438659719",{"facility":305,"status":174,"city":306,"state":307,"zip":308,"country":309,"countryCode":310,"cosmosGeoPoint":311,"geoPoint":315,"contacts":316},"Biocenter ( Site 0402)","Concepción","Biobio","4070196","Chile","CL",{"type":181,"coordinates":312},[313,314],-73.04977,-36.82699,{"lat":314,"lon":313},[317],{"name":188,"role":168,"phone":318,"phoneExt":73,"email":73},"+5695684078",{"facility":320,"status":174,"city":321,"state":322,"zip":323,"country":309,"countryCode":310,"cosmosGeoPoint":324,"geoPoint":328,"contacts":329},"Fundacion Arturo Lopez Perez FALP ( Site 0404)","Santiago","Region M. de Santiago","7500836",{"type":181,"coordinates":325},[326,327],-70.64827,-33.45694,{"lat":327,"lon":326},[330],{"name":188,"role":168,"phone":331,"phoneExt":73,"email":73},"+56224205098",{"facility":333,"status":174,"city":334,"state":335,"zip":336,"country":337,"countryCode":338,"cosmosGeoPoint":339,"geoPoint":343,"contacts":344},"Beijing Cancer hospital ( Site 0501)","Beijing","Beijing Municipality","100142","China","CN",{"type":181,"coordinates":340},[341,342],116.39723,39.9075,{"lat":342,"lon":341},[345],{"name":188,"role":168,"phone":346,"phoneExt":73,"email":73},"+861088196118",{"facility":348,"status":174,"city":349,"state":350,"zip":351,"country":337,"countryCode":338,"cosmosGeoPoint":352,"geoPoint":356,"contacts":357},"Fudan University Shanghai Cancer Center ( Site 0504)","Shanghai","Shanghai Municipality","200030",{"type":181,"coordinates":353},[354,355],121.45806,31.22222,{"lat":355,"lon":354},[358],{"name":188,"role":168,"phone":359,"phoneExt":73,"email":73},"+860216417559088217",{"facility":361,"status":174,"city":362,"state":363,"zip":364,"country":365,"countryCode":366,"cosmosGeoPoint":367,"geoPoint":371,"contacts":372},"Evangelismos General Hospital of Athens ( Site 1501)","Athens","Attica","106 76","Greece","GR",{"type":181,"coordinates":368},[369,370],23.72784,37.98376,{"lat":370,"lon":369},[373],{"name":188,"role":168,"phone":374,"phoneExt":73,"email":73},"00302132041",{"facility":376,"status":174,"city":362,"state":363,"zip":377,"country":365,"countryCode":366,"cosmosGeoPoint":378,"geoPoint":380,"contacts":381},"General Hospital of Athens \"Laiko\" ( Site 1502)","115 27",{"type":181,"coordinates":379},[369,370],{"lat":370,"lon":369},[382],{"name":188,"role":168,"phone":383,"phoneExt":73,"email":73},"+302132061702",{"facility":385,"status":174,"city":386,"state":73,"zip":387,"country":388,"countryCode":389,"cosmosGeoPoint":390,"geoPoint":394,"contacts":395},"Hadassah Medical Center ( Site 0701)","Jerusalem","9112001","Israel","IL",{"type":181,"coordinates":391},[392,393],35.21633,31.76904,{"lat":393,"lon":392},[396],{"name":188,"role":168,"phone":397,"phoneExt":73,"email":73},"+97226777333",{"facility":399,"status":174,"city":400,"state":73,"zip":401,"country":388,"countryCode":389,"cosmosGeoPoint":402,"geoPoint":406,"contacts":407},"Sheba Medical Center ( Site 0702)","Ramat Gan","5265601",{"type":181,"coordinates":403},[404,405],34.81065,32.08227,{"lat":405,"lon":404},[408],{"name":188,"role":168,"phone":409,"phoneExt":73,"email":73},"+97235303030",{"facility":411,"status":174,"city":412,"state":73,"zip":413,"country":388,"countryCode":389,"cosmosGeoPoint":414,"geoPoint":418,"contacts":419},"Sourasky Medical Center ( Site 0704)","Tel Aviv","6423906",{"type":181,"coordinates":415},[416,417],34.78057,32.08088,{"lat":417,"lon":416},[420],{"name":188,"role":168,"phone":421,"phoneExt":73,"email":73},"+97236974444",{"facility":423,"status":174,"city":424,"state":425,"zip":426,"country":427,"countryCode":428,"cosmosGeoPoint":429,"geoPoint":433,"contacts":434},"Pratia MCM Krakow ( Site 1702)","Krakow","Lesser Poland Voivodeship","30-727","Poland","PL",{"type":181,"coordinates":430},[431,432],19.93658,50.06143,{"lat":432,"lon":431},[435],{"name":188,"role":168,"phone":436,"phoneExt":73,"email":73},"+48122958160",{"facility":438,"status":174,"city":439,"state":440,"zip":441,"country":427,"countryCode":428,"cosmosGeoPoint":442,"geoPoint":446,"contacts":447},"Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 1701)","Warsaw","Masovian Voivodeship","02-781",{"type":181,"coordinates":443},[444,445],21.01178,52.22977,{"lat":445,"lon":444},[448],{"name":188,"role":168,"phone":449,"phoneExt":73,"email":73},"+48225462000",{"facility":451,"status":174,"city":452,"state":73,"zip":453,"country":454,"countryCode":73,"cosmosGeoPoint":455,"geoPoint":459,"contacts":460},"Samsung Medical Center ( Site 0801)","Seoul","06351","South Korea",{"type":181,"coordinates":456},[457,458],126.9784,37.566,{"lat":458,"lon":457},[461],{"name":188,"role":168,"phone":462,"phoneExt":73,"email":73},"+82234106548",{"facility":464,"status":174,"city":465,"state":466,"zip":467,"country":468,"countryCode":469,"cosmosGeoPoint":470,"geoPoint":474,"contacts":475},"Institut Català d'Oncologia (ICO) - Badalona ( Site 0904)","Badalona","Barcelona","08916","Spain","ES",{"type":181,"coordinates":471},[472,473],2.24741,41.45004,{"lat":473,"lon":472},[476],{"name":188,"role":168,"phone":477,"phoneExt":73,"email":73},"34 934978387",{"facility":479,"status":174,"city":480,"state":481,"zip":482,"country":468,"countryCode":469,"cosmosGeoPoint":483,"geoPoint":487,"contacts":488},"Hospital Virgen de la Victoria ( Site 0905)","Málaga","Malaga","29010",{"type":181,"coordinates":484},[485,486],-4.42034,36.72016,{"lat":486,"lon":485},[489],{"name":188,"role":168,"phone":490,"phoneExt":73,"email":73},"34 923291100,56621",{"facility":492,"status":174,"city":466,"state":73,"zip":493,"country":468,"countryCode":469,"cosmosGeoPoint":494,"geoPoint":498,"contacts":499},"Hospital Universitari Vall de Hebron ( Site 0903)","08035",{"type":181,"coordinates":495},[496,497],2.15899,41.38879,{"lat":497,"lon":496},[500],{"name":188,"role":168,"phone":501,"phoneExt":73,"email":73},"+34932746000, 2347",{"facility":503,"status":174,"city":504,"state":73,"zip":505,"country":468,"countryCode":469,"cosmosGeoPoint":506,"geoPoint":510,"contacts":511},"Hospital Universitario Gregorio Maranon ( Site 0902)","Madrid","28007",{"type":181,"coordinates":507},[508,509],-3.70256,40.4165,{"lat":509,"lon":508},[512],{"name":188,"role":168,"phone":513,"phoneExt":73,"email":73},"34 915868888",{"facility":515,"status":174,"city":516,"state":73,"zip":517,"country":468,"countryCode":469,"cosmosGeoPoint":518,"geoPoint":522,"contacts":523},"Hospital Universitario de Salamanca ( Site 0906)","Salamanca","37007",{"type":181,"coordinates":519},[520,521],-5.66388,40.96882,{"lat":521,"lon":520},[524],{"name":188,"role":168,"phone":525,"phoneExt":73,"email":73},"+34923291100ext56621",{"facility":527,"status":174,"city":528,"state":73,"zip":529,"country":530,"countryCode":531,"cosmosGeoPoint":532,"geoPoint":536,"contacts":537},"National Taiwan University Hospital ( Site 1001)","Taipei","100225","Taiwan","TW",{"type":181,"coordinates":533},[534,535],121.52639,25.05306,{"lat":535,"lon":534},[538],{"name":188,"role":168,"phone":539,"phoneExt":73,"email":73},"02-23123456",{"facility":541,"status":174,"city":542,"state":73,"zip":543,"country":530,"countryCode":531,"cosmosGeoPoint":544,"geoPoint":548,"contacts":549},"Chang Gung Medical Foundation-Linkou Branch ( Site 1002)","Taoyuan","333",{"type":181,"coordinates":545},[546,547],121.29696,24.99368,{"lat":547,"lon":546},[550],{"name":188,"role":168,"phone":551,"phoneExt":73,"email":73},"03-3281200",{"facility":553,"status":174,"city":554,"state":73,"zip":555,"country":556,"countryCode":73,"cosmosGeoPoint":557,"geoPoint":561,"contacts":562},"Hacettepe Universite Hastaneleri ( Site 1110)","Ankara","06230","Turkey (Türkiye)",{"type":181,"coordinates":558},[559,560],32.85427,39.91987,{"lat":560,"lon":559},[563],{"name":188,"role":168,"phone":564,"phoneExt":73,"email":73},"+905348719633",{"facility":566,"status":174,"city":567,"state":73,"zip":568,"country":556,"countryCode":73,"cosmosGeoPoint":569,"geoPoint":573,"contacts":574},"Sisli Florence Nightingale Hastanesi ( Site 1112)","Istanbul","34381",{"type":181,"coordinates":570},[571,572],28.94966,41.01384,{"lat":572,"lon":571},[575],{"name":188,"role":168,"phone":576,"phoneExt":73,"email":73},"+905348310606",{"facility":578,"status":174,"city":579,"state":73,"zip":580,"country":556,"countryCode":73,"cosmosGeoPoint":581,"geoPoint":585,"contacts":586},"Ondokuz Mayıs Universitesi ( Site 1113)","Samsun","55270",{"type":181,"coordinates":582},[583,584],36.3361,41.27976,{"lat":584,"lon":583},[587],{"name":188,"role":168,"phone":588,"phoneExt":73,"email":73},"+905068756912",{"type":590,"investigatorFullName":73,"investigatorTitle":73,"investigatorAffiliation":73,"oldNameTitle":73,"oldOrganization":73},"SPONSOR","100641666","phase-2-a-clinical-trial-of-mk-1045-and-rituximab-in-people-with-follicular-lymphoma-mk-1045-007-100641666",false,"NCT07634471","A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)","A Phase 2\u002F3 Randomized, Open-label Study of MK-1045 in Combination With Rituximab in Participants With 1L Follicular Lymphoma","Inclusion Criteria:\n\n* Has biopsy-proven, previously untreated, histologically confirmed cluster of differentiation (CD)19-positive and CD20-positive classical follicular lymphoma (FL), with Ann Arbor Stage II-IV disease and a Follicular Lymphoma International Prognostic Index (FLIPI) score of 2-5.\n* Has radiographically measurable disease per the Lugano Response Criteria.\n* Has provided a newly obtained core or excisional biopsy or archival tissue of a tumor lesion not previously irradiated.\n* If human immunodeficiency virus (HIV)-positive, has well-controlled HIV on antiretroviral therapy (ART).\n* If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy for at least 4 weeks and will continue it.\n* If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.\n\nExclusion Criteria:\n\n* Has received prior systemic anticancer therapy or radiotherapy for FL.\n* Has follicular large B-cell lymphoma or any other subtype of FL other than classical FL.\n* Has FL that has transformed into a more aggressive type of lymphoma.\n* History or presence of clinically relevant central nervous system (CNS) diseases.\n* Has history of serious cardiovascular and cerebrovascular diseases.\n* Is HIV-infected with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n* Has known active CNS lymphoma or involvement.\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years.\n* Has active infection requiring systemic therapy.\n* Has chronic liver disease, including liver cirrhosis of Child-Pugh class B or C.\n* Has not adequately recovered from major surgery or has ongoing surgical complications.","ALL","18 Years",{"count":601,"type":602},960,"ESTIMATED","INTERVENTIONAL",[605,606],"PHASE2","PHASE3","Researchers are looking for new ways to treat follicular lymphoma (FL). A standard (usual) treatment for FL includes a targeted therapy called rituximab and chemotherapy. In this study, researchers want to learn if giving a study medicine called MK-1045 and rituximab can treat FL. MK-1045 is a type of treatment called immunotherapy.\n\nThe goals of this study are to learn:\n\n* About the safety of MK-1045 and rituximab, and if people tolerate them when given together\n* If people who receive MK-1045 and rituximab have the cancer go away\n* If people who receive MK-1045 and rituximab live longer without their cancer getting worse compared to those who receive standard treatment (rituximab and chemotherapy)",[609],"Follicular Lymphoma","2026-10-06",{"date":612,"type":613},"2026-10-08","ACTUAL",{"date":615,"type":613},"2026-06-22",{"date":617,"type":602},"2035-07-23",{"name":5,"class":6},32]