[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556568":3},{"organization":4,"outcomesModule":7,"designInfo":93,"detailedDescription":100,"studyPopulation":92,"armGroups":101,"interventions":112,"overallOfficials":92,"centralContacts":120,"locations":126,"responsibleParty":891,"collaborators":92,"id":893,"slug":894,"hasResults":895,"nctId":896,"briefTitle":897,"officialTitle":898,"acronym":899,"eligibilityCriteria":900,"healthyVolunteers":895,"sex":901,"minAge":902,"maxAge":92,"enrollmentInfo":903,"targetDuration":92,"studyType":906,"phases":907,"briefSummary":909,"conditions":910,"keywords":914,"overallStatus":142,"whyStopped":92,"lastUpdateSubmitDate":917,"lastUpdatePostDateStruct":918,"startDateStruct":921,"completionDateStruct":923,"leadSponsor":925,"locationsCount":926},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":92},[9],{"measure":10,"description":11,"timeFrame":12},"Overall response rate (ORR) (central review)","Overall response summarized via overall response rate (ORR), defined as the proportion of participants achieving either a Partial Response (PR) or Complete Response (CR) based on Lugano 2014 response criteria for non-Hodgkin Lymphoma, as determined by central review","Module 1: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to approximately 24 months. Module 2: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to approximately 12 months.",[14,18,22,26,30,33,37,40,44,48,51,54,57,61,64,67,70,73,77,80,83,86,89],{"measure":15,"description":16,"timeFrame":17},"Incidence, nature and severity of Adverse Events (AEs), Serious AEs and AEs of Special Interest (AESI)","Incidence, nature, and severity of AEs\u002FSAEs (based on NCI CTCAE v5.0\u002FASTCT criteria\u002FCairo-Bishop criteria with Howard modification) and changes in laboratory data, vital signs, and electrocardiograms (ECGs) compared with baseline.\n\nIncidence and severity of AESIs.","From time of Informed Consent to 90-day safety follow-up visit",{"measure":19,"description":20,"timeFrame":21},"Incidence and nature of study drug discontinuation, dose reduction, and dose delay due to Adverse Events (AEs)","Incidence and nature of study drug discontinuation, dose reduction, and dose delay due to AEs","From the start of treatment up to 2 years in Module 1 and up to 1 year for Module 2",{"measure":23,"description":24,"timeFrame":25},"Duration of response (DoR)","Defined as the time from the date of first documented response until date of documented progression by Lugano 2014 response criteria as determined by central review or death due to any cause.","To be assessed up to approximately 5 years.",{"measure":27,"description":28,"timeFrame":29},"Complete response (CR) rate (central review)","Complete response (CR) based on Lugano 2014 Response criteria for non-Hodgkin lymphoma, as determined by central review.","To be assessed up through study completion, up to approximately 5 years",{"measure":31,"description":32,"timeFrame":29},"Complete response (CR) rate (investigator assessment)","Complete response (CR) based on Lugano 2014 Response criteria of non-Hodgkin lymphoma, as determined by investigator assessment.",{"measure":34,"description":35,"timeFrame":36},"Overall response rate (ORR) (investigator assessment)","Overall response summarized via overall response rate (ORR), defined as the proportion of participants achieving either a partial response (PR) or complete response (CR) based on Lugano 2014 Response criteria of non-Hodgkin lymphoma, as determined by investigator assessment.","Module 1: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to about 24 months. Module 2: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to about 12 months.",{"measure":38,"description":39,"timeFrame":25},"Duration of complete response (DoCR)","Defined as the time from achievement of complete response (CR) to relapse or death due any cause, as assessed by central review",{"measure":41,"description":42,"timeFrame":43},"Time to response (TTR)","Defined as the time from first dose until first documented objective response, as assessed by central review.","From the first dose until the first objective response, up to approximately 5 years.",{"measure":45,"description":46,"timeFrame":47},"Event-free survival (EFS)","Defined as the time from first dose until disease progression, relapse, or initiation of subsequent systemic anti-lymphoma treatment, or death due to any cause, as assessed by central review.","To be assessed up to approximately 5 years",{"measure":49,"description":50,"timeFrame":25},"Progression-free survival (PFS)","Defined as the time from the date of first dose until documented disease progression based on Lugano 2014 Response Criteria, or death due to any cause.",{"measure":52,"description":53,"timeFrame":25},"Time to next anti-lymphoma (TTNT)","Defined as time from first dose until the start date of subsequent anti-lymphoma therapy or death due to any cause.",{"measure":55,"description":56,"timeFrame":25},"Overall survival (OS)","Defined as the time from first dose until the date of death due to any cause.",{"measure":58,"description":59,"timeFrame":60},"Plasma concentrations of surovatamig","To characterize the plasma concentration of surovatamig as monotherapy","From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment",{"measure":62,"description":63,"timeFrame":60},"Area under the concentration time curve (AUC)","To characterize the pharmacokinetics (PK) AUC of surovatamig as monotherapy",{"measure":65,"description":66,"timeFrame":60},"Maximum plasma concentration (Cmax)","To characterize the pharmacokinetics (PK) (Cmax) of surovatamig as monotherapy",{"measure":68,"description":69,"timeFrame":60},"Time to maximum plasma concentration (Tmax)","To characterize the pharmacokinetics (PK) (Tmax) of surovatamig as monotherapy",{"measure":71,"description":72,"timeFrame":60},"A trough concentration (Cthrough)","To characterize the pharmacokinetics (PK) (C through) of surovatamig as monotherapy",{"measure":74,"description":75,"timeFrame":76},"Immunogenecity of surovatamig","The number and percentage of participants who develop Anti-Drug Antibodies (ADAs)","From the first dose of study intervention, at predefined intervals throughout the administration of surovatamig (2 years in Module 1 and 1 year in Module 2)",{"measure":78,"description":79,"timeFrame":29},"Change from baseline in EORTC IL233 scales","To evaluate patient-reported tolerability of surovatamig, including severity of key treatment-related symptoms and overall side-effect burden. IL233 will evaluate different levels of severity in fatigue, pain and cognition.\n\nEORCT IL233 scales - European Organisation for Research and Treatment of Cancer Il233 scales- this questionnaire is assessing Patient-reported Severity of Treatment-and Disease-related Symptoms, it is a 15-item questionnaire, and each item is rated on a 4-point scale ranging from 1 (not at all) to 4 (very much).",{"measure":81,"description":82,"timeFrame":29},"Change from baseline in PGI-TT scale","To evaluate patient-reported tolerability of surovatamig, overall side-effect burden.\n\nPGI-TT scale - Patient Global Impression of Treatment Tolerability is a 1 item questionnaire rated on a 7-point scale ranging from \"not at all\" to \"very much\"",{"measure":84,"description":85,"timeFrame":29},"Change from baseline in EORTC IL 232 QL2 scores","To evaluate patient-reported severity of key disease-related symptoms, as well as the impact of disease on lymphoma-specific concerns, while on surovatamig.\n\nEuropean Organization for Research and Treatment of Cancer (EORTC) IL 232 will be used to evaluate impacts on function and HRQoL (health-related quality of life) due to treatment and disease, which includes 13 EORTC QLQ-C30 function items assessing physical, social, role, and emotional function, as well as the EORTC QLQ-C30's 2 global health\u002FHRQoL items.",{"measure":87,"description":88,"timeFrame":29},"Change from baseline in FACT-LymS scales","To evaluate patient-reported severity of key disease-related symptoms, as well as the impact of disease on lymphoma-specific concerns, while on surovatamig\n\nFunctional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) FACT-LymS - Lymphoma-specific Subscale from the FACT-Lym Questionnaire is a 15-item questionnaire, and each item is rated on a 5-point scale ranging from 0 (not at all) to 4 (very much).",{"measure":90,"description":91,"timeFrame":29},"Minimal residual disease (MRD)","MRD-negative complete response (CR) summarized through MRD-negative rate, defined as the proportion of participants who achieved MRD-negativity in plasma by next generation sequencing (NGS) while in complete response (CR) per the Lugano Response criteria for non-Hodgkin lymphoma as determined by central review.",null,{"allocation":94,"interventionModel":95,"interventionModelDescription":96,"primaryPurpose":97,"observationalModel":92,"timePerspective":92,"maskingInfo":98},"NON_RANDOMIZED","SEQUENTIAL","The trial will assess surovatamig (AZD0486) monotherapy given by IV infusion. Module 1 will evaluate the efficacy and safety of surovatamig monotherapy at the recommended Phase 2 dose (RP2D), in participants 18 years of age or older , with relapsed or refractory (R\u002FR) follicular lymphoma (FL) who have received ≥ 2 prior therapies. Module 2 will evaluate the efficacy and safety of surovatamig monotherapy at the RP2D for participants 18 years of age or older with (R\u002FR) large B-cell lymphoma (LBCL) who have received ≥ 2 prior therapies.","TREATMENT",{"masking":99,"maskingDescription":92,"whoMasked":92},"NONE","This is a modular, Phase II, multicenter, single-arm, open-label study to evaluate the efficacy and safety of surovatamig (AZD0486) monotherapy administered as an intravenous (IV) infusion in participants with relapsed or refractory B-NHL. The purpose of this study is to determine the efficacy and safety of surovatamig (AZD0486) administered at the RP2D in adults 18 years of age or older with relapsed or refractory B-NHL.",[102,108],{"label":103,"type":104,"description":105,"interventionNames":106},"Module 1: Surovatamig Monotherapy in Participants with Relapsed or Refractory Follicular Lymphoma","EXPERIMENTAL","In Module 1, the efficacy and safety of surovatamig at the RP2D will be evaluated in R\u002FR FL. Surovatamig will be administered as intravenous infusion.",[107],"Drug: Surovatamig",{"label":109,"type":104,"description":110,"interventionNames":111},"Module 2: Surovatamig Monotherapy in Participants with Relapsed or Refractory LBCL","In Module 2, the efficacy and safety of surovatamig at the RP2D will be evaluated in R\u002FR LBCL. Surovatamig will be administered as intravenous infusion.",[107],[113],{"type":114,"name":115,"description":116,"armGroupLabels":117,"otherNames":118},"DRUG","Surovatamig","Investigational Product administered via intravenous infusion.",[103,109],[119],"AZD0486",[121],{"name":122,"role":123,"phone":124,"phoneExt":92,"email":125},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[127,141,151,160,168,177,186,194,203,212,221,230,238,247,256,265,274,282,286,295,304,312,321,330,340,348,351,359,369,378,383,394,402,410,418,428,433,441,449,457,465,472,480,485,493,501,511,519,527,537,545,553,561,571,579,587,595,603,612,619,629,637,645,653,658,666,676,684,692,700,708,716,724,732,741,746,751,756,761,771,779,787,797,805,815,820,828,833,841,849,859,867,875,883],{"facility":128,"status":129,"city":130,"state":131,"zip":132,"country":133,"countryCode":134,"cosmosGeoPoint":135,"geoPoint":140,"contacts":92},"Research Site","WITHDRAWN","Phoenix","Arizona","85054","United States","US",{"type":136,"coordinates":137},"Point",[138,139],-112.07404,33.44838,{"lat":139,"lon":138},{"facility":128,"status":142,"city":143,"state":144,"zip":145,"country":133,"countryCode":134,"cosmosGeoPoint":146,"geoPoint":150,"contacts":92},"RECRUITING","Duarte","California","91010",{"type":136,"coordinates":147},[148,149],-117.97729,34.13945,{"lat":149,"lon":148},{"facility":128,"status":129,"city":152,"state":153,"zip":154,"country":133,"countryCode":134,"cosmosGeoPoint":155,"geoPoint":159,"contacts":92},"Jacksonville","Florida","32224",{"type":136,"coordinates":156},[157,158],-81.65565,30.33218,{"lat":158,"lon":157},{"facility":128,"status":142,"city":161,"state":153,"zip":162,"country":133,"countryCode":134,"cosmosGeoPoint":163,"geoPoint":167,"contacts":92},"Tampa","33612",{"type":136,"coordinates":164},[165,166],-82.45843,27.94752,{"lat":166,"lon":165},{"facility":128,"status":142,"city":169,"state":170,"zip":171,"country":133,"countryCode":134,"cosmosGeoPoint":172,"geoPoint":176,"contacts":92},"Chicago","Illinois","60637",{"type":136,"coordinates":173},[174,175],-87.65005,41.85003,{"lat":175,"lon":174},{"facility":128,"status":129,"city":178,"state":179,"zip":180,"country":133,"countryCode":134,"cosmosGeoPoint":181,"geoPoint":185,"contacts":92},"Iowa City","Iowa","52242",{"type":136,"coordinates":182},[183,184],-91.53017,41.66113,{"lat":184,"lon":183},{"facility":128,"status":142,"city":187,"state":179,"zip":188,"country":133,"countryCode":134,"cosmosGeoPoint":189,"geoPoint":193,"contacts":92},"Waukee","50263",{"type":136,"coordinates":190},[191,192],-93.88523,41.61166,{"lat":192,"lon":191},{"facility":128,"status":129,"city":195,"state":196,"zip":197,"country":133,"countryCode":134,"cosmosGeoPoint":198,"geoPoint":202,"contacts":92},"Overland Park","Kansas","66204",{"type":136,"coordinates":199},[200,201],-94.67079,38.98223,{"lat":201,"lon":200},{"facility":128,"status":142,"city":204,"state":205,"zip":206,"country":133,"countryCode":134,"cosmosGeoPoint":207,"geoPoint":211,"contacts":92},"Rochester","Minnesota","55905",{"type":136,"coordinates":208},[209,210],-92.4699,44.02163,{"lat":210,"lon":209},{"facility":128,"status":129,"city":213,"state":214,"zip":215,"country":133,"countryCode":134,"cosmosGeoPoint":216,"geoPoint":220,"contacts":92},"St Louis","Missouri","63110",{"type":136,"coordinates":217},[218,219],-90.19789,38.62727,{"lat":219,"lon":218},{"facility":128,"status":129,"city":222,"state":223,"zip":224,"country":133,"countryCode":134,"cosmosGeoPoint":225,"geoPoint":229,"contacts":92},"New Brunswick","New Jersey","08901",{"type":136,"coordinates":226},[227,228],-74.45182,40.48622,{"lat":228,"lon":227},{"facility":128,"status":142,"city":231,"state":231,"zip":232,"country":133,"countryCode":134,"cosmosGeoPoint":233,"geoPoint":237,"contacts":92},"New York","10016",{"type":136,"coordinates":234},[235,236],-74.00597,40.71427,{"lat":236,"lon":235},{"facility":128,"status":142,"city":239,"state":240,"zip":241,"country":133,"countryCode":134,"cosmosGeoPoint":242,"geoPoint":246,"contacts":92},"Charlotte","North Carolina","28204",{"type":136,"coordinates":243},[244,245],-80.84313,35.22709,{"lat":245,"lon":244},{"facility":128,"status":142,"city":248,"state":249,"zip":250,"country":133,"countryCode":134,"cosmosGeoPoint":251,"geoPoint":255,"contacts":92},"Columbus","Ohio","43210",{"type":136,"coordinates":252},[253,254],-82.99879,39.96118,{"lat":254,"lon":253},{"facility":128,"status":142,"city":257,"state":258,"zip":259,"country":133,"countryCode":134,"cosmosGeoPoint":260,"geoPoint":264,"contacts":92},"Portland","Oregon","97239",{"type":136,"coordinates":261},[262,263],-122.67621,45.52345,{"lat":263,"lon":262},{"facility":128,"status":142,"city":266,"state":267,"zip":268,"country":133,"countryCode":134,"cosmosGeoPoint":269,"geoPoint":273,"contacts":92},"Philadelphia","Pennsylvania","19104",{"type":136,"coordinates":270},[271,272],-75.16362,39.95238,{"lat":272,"lon":271},{"facility":128,"status":142,"city":275,"state":267,"zip":276,"country":133,"countryCode":134,"cosmosGeoPoint":277,"geoPoint":281,"contacts":92},"Pittsburgh","15232",{"type":136,"coordinates":278},[279,280],-79.99589,40.44062,{"lat":280,"lon":279},{"facility":128,"status":129,"city":275,"state":267,"zip":276,"country":133,"countryCode":134,"cosmosGeoPoint":283,"geoPoint":285,"contacts":92},{"type":136,"coordinates":284},[279,280],{"lat":280,"lon":279},{"facility":128,"status":142,"city":287,"state":288,"zip":289,"country":133,"countryCode":134,"cosmosGeoPoint":290,"geoPoint":294,"contacts":92},"Nashville","Tennessee","37203",{"type":136,"coordinates":291},[292,293],-86.78444,36.16589,{"lat":293,"lon":292},{"facility":128,"status":142,"city":296,"state":297,"zip":298,"country":133,"countryCode":134,"cosmosGeoPoint":299,"geoPoint":303,"contacts":92},"Austin","Texas","78704",{"type":136,"coordinates":300},[301,302],-97.74306,30.26715,{"lat":302,"lon":301},{"facility":128,"status":142,"city":305,"state":297,"zip":306,"country":133,"countryCode":134,"cosmosGeoPoint":307,"geoPoint":311,"contacts":92},"Houston","77030",{"type":136,"coordinates":308},[309,310],-95.36327,29.76328,{"lat":310,"lon":309},{"facility":128,"status":313,"city":314,"state":297,"zip":315,"country":133,"countryCode":134,"cosmosGeoPoint":316,"geoPoint":320,"contacts":92},"NOT_YET_RECRUITING","San Antonio","78229",{"type":136,"coordinates":317},[318,319],-98.49363,29.42412,{"lat":319,"lon":318},{"facility":128,"status":142,"city":322,"state":323,"zip":324,"country":133,"countryCode":134,"cosmosGeoPoint":325,"geoPoint":329,"contacts":92},"Milwaukee","Wisconsin","53226",{"type":136,"coordinates":326},[327,328],-87.90647,43.0389,{"lat":328,"lon":327},{"facility":128,"status":142,"city":331,"state":92,"zip":332,"country":333,"countryCode":334,"cosmosGeoPoint":335,"geoPoint":339,"contacts":92},"Heidelberg","3084","Australia","AU",{"type":136,"coordinates":336},[337,338],145.06667,-37.75,{"lat":338,"lon":337},{"facility":128,"status":142,"city":341,"state":92,"zip":342,"country":333,"countryCode":334,"cosmosGeoPoint":343,"geoPoint":347,"contacts":92},"Kogarah","NSW 2217",{"type":136,"coordinates":344},[345,346],151.13564,-33.9681,{"lat":346,"lon":345},{"facility":128,"status":142,"city":349,"state":92,"zip":350,"country":333,"countryCode":334,"cosmosGeoPoint":92,"geoPoint":92,"contacts":92},"Macquarie University","2109",{"facility":128,"status":142,"city":352,"state":92,"zip":353,"country":333,"countryCode":334,"cosmosGeoPoint":354,"geoPoint":358,"contacts":92},"Nedlands","6009",{"type":136,"coordinates":355},[356,357],115.8073,-31.98184,{"lat":357,"lon":356},{"facility":128,"status":129,"city":360,"state":92,"zip":361,"country":362,"countryCode":363,"cosmosGeoPoint":364,"geoPoint":368,"contacts":92},"Porto Alegre","90035903","Brazil","BR",{"type":136,"coordinates":365},[366,367],-51.23019,-30.03283,{"lat":367,"lon":366},{"facility":128,"status":370,"city":371,"state":92,"zip":372,"country":362,"countryCode":363,"cosmosGeoPoint":373,"geoPoint":377,"contacts":92},"ACTIVE_NOT_RECRUITING","São Paulo","01401-002",{"type":136,"coordinates":374},[375,376],-46.63611,-23.5475,{"lat":376,"lon":375},{"facility":128,"status":370,"city":371,"state":92,"zip":379,"country":362,"countryCode":363,"cosmosGeoPoint":380,"geoPoint":382,"contacts":92},"05652-900",{"type":136,"coordinates":381},[375,376],{"lat":376,"lon":375},{"facility":128,"status":129,"city":384,"state":385,"zip":386,"country":387,"countryCode":388,"cosmosGeoPoint":389,"geoPoint":393,"contacts":92},"Barrie","Ontario","L4M 6M2","Canada","CA",{"type":136,"coordinates":390},[391,392],-79.66634,44.40011,{"lat":392,"lon":391},{"facility":128,"status":142,"city":395,"state":385,"zip":396,"country":387,"countryCode":388,"cosmosGeoPoint":397,"geoPoint":401,"contacts":92},"Brampton","L6R 3J7",{"type":136,"coordinates":398},[399,400],-79.76633,43.68341,{"lat":400,"lon":399},{"facility":128,"status":142,"city":403,"state":385,"zip":404,"country":387,"countryCode":388,"cosmosGeoPoint":405,"geoPoint":409,"contacts":92},"Ottawa","K1H 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Transfusion and\u002For growth factor are allowed but counts must be stable for at least 72 hours afterwards prior to screening\n   * Adequate liver function: total bilirubin \\\u003C1.5x ULN, AST\u002FALT ≤ 3xULN or \\\u003C 5 × ULN in the presence of lymphoma involvement of the liver\n   * Adequate renal function: creatinine clearance (CrCl) of ≥ 45 mL\u002Fmin\n   * Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 45% by echocardiogram or MUGA\n\n   The above is a summary, other inclusion criteria details may apply.\n2. 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