[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100379997":3},{"organization":4,"outcomesModule":7,"designInfo":76,"detailedDescription":83,"studyPopulation":75,"armGroups":84,"interventions":117,"overallOfficials":135,"centralContacts":140,"locations":145,"responsibleParty":541,"collaborators":75,"id":543,"slug":75,"hasResults":544,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":75,"eligibilityCriteria":548,"healthyVolunteers":544,"sex":549,"minAge":550,"maxAge":75,"enrollmentInfo":551,"targetDuration":75,"studyType":554,"phases":555,"briefSummary":557,"conditions":558,"keywords":561,"overallStatus":173,"whyStopped":75,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":573},{"fullName":5,"class":6},"Seagen Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":75},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Number of participants with adverse events (AEs)","Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.","Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years",{"measure":14,"description":15,"timeFrame":12},"Number of participants with laboratory abnormalities","To be summarized using descriptive statistics.",{"measure":17,"description":15,"timeFrame":18},"Number of participants with a dose-limiting toxicity (DLT) at each dose level (Parts A and D only)","Though end of DLT evaluation period; up to approximately 4 weeks",[20,22,24,26,28,30,32,36,39,42,45,48,51,54,57,60,63,66,69,72],{"measure":21,"description":15,"timeFrame":12},"AUC - Area under the plasma concentration-time curve",{"measure":23,"description":15,"timeFrame":12},"Tmax - Time to maximum concentration attained",{"measure":25,"description":15,"timeFrame":12},"Cmax - Maximum observed plasma concentration",{"measure":27,"description":15,"timeFrame":12},"Ctrough - Minimum plasma concentration per dosing interval",{"measure":29,"description":15,"timeFrame":12},"T1\u002F2 - Terminal elimination half-life",{"measure":31,"description":15,"timeFrame":12},"Incidence of antidrug antibodies (ADA)",{"measure":33,"description":34,"timeFrame":35},"Complete remission (CR) Rate and complete remission equivalent (CReq) rate","Proportion of participants with AML, MDS\u002FAML or MDS who achieve CR or CReq","Up to approximately 4 years",{"measure":37,"description":38,"timeFrame":35},"Complete remission with incomplete blood count recovery (CRi) rate","Proportion of participants with AML who achieve CRi",{"measure":40,"description":41,"timeFrame":35},"Complete remission with limited count recovery (CRL) rate for participants with MDS or MDS\u002FAML","Proportion of participants with MDS or MDS\u002FAML who achieve CRL",{"measure":43,"description":44,"timeFrame":35},"Complete remission with partial hematologic recovery (CRh) rate","Proportion of participants with AML, MDS\u002FAML, or MDS who achieve CRh",{"measure":46,"description":47,"timeFrame":35},"Hematologic response (HI) rate","Proportion of participants with MDS or MDS\u002FAML with HI",{"measure":49,"description":50,"timeFrame":35},"Overall response rate (ORR)","For AML, the proportion of participants who achieve a best response of CR, CRi, CRh, or partial response (PR). For MDS, the proportion of participants who achieve a best response of CR, CReq, CRL, CRh, PR, or HI",{"measure":52,"description":53,"timeFrame":35},"Duration of remission (DOR)","For AML, the time from first CR\u002FCRi\u002FCRh\u002FPR response to the first documentation of disease progression, start of new anticancer therapy, or death due to any cause. For MDS, the time from first CR (or Req)\u002FCRL\u002FCRh\u002FPR to the first documentation of disease progression, start of new anticancer therapy, or death due to any cause",{"measure":55,"description":56,"timeFrame":35},"Overall survival (OS)","Time from start of study treatment to the date of death due to any cause",{"measure":58,"description":59,"timeFrame":35},"Event-free survival (EFS)","Time from first dose to the first documentation of progression, failure to achieve remission within 6 months of study entry, disease relapse, or death due to any cause, whichever comes first.",{"measure":61,"description":62,"timeFrame":35},"Progression-free survival (PFS)","Time from first dose to the first documentation of progression, disease relapse, or death from any cause, whichever comes first",{"measure":64,"description":65,"timeFrame":35},"MRD-negative ORR","Proportion of participants with AML or MDS who achieve MRD-negative ORR",{"measure":67,"description":68,"timeFrame":35},"Time to response (TTR)","Time from start of study treatment to the first documentation of objective response",{"measure":70,"description":71,"timeFrame":35},"Rate of conversion to transfusion independence (TI)","Proportion of participants who convert from transfusion dependence at baseline to TI post-baseline",{"measure":73,"description":74,"timeFrame":35},"Rate of TI maintenance","Proportion of participants who were TI at baseline and maintain TI post-baseline",null,{"allocation":77,"interventionModel":78,"interventionModelDescription":79,"primaryPurpose":80,"observationalModel":75,"timePerspective":75,"maskingInfo":81},"NON_RANDOMIZED","SEQUENTIAL","Parts B and C may enroll in parallel after enrollment of Part A is complete. Part D will enroll after Part A is complete. Parts E, F and Part G will enroll in parallel once Part D is complete.","TREATMENT",{"masking":82,"maskingDescription":75,"whoMasked":75},"NONE","This is a phase 1, open-label, multicenter, dose-finding, and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of SEA-CD70 monotherapy and SEA-CD70 in combination with azacitidine in adults with myeloid malignancies. The study will be conducted in up to 6 parts.\n\n* Part A is a dose-escalation cohort designed to identify the MTD or recommended expansion dose of SEA-CD70 monotherapy in participants with relapsed\u002Frefractory (hypomethylating agent \\[HMA\\]-failure) MDS.\n* Part B is an expansion cohort designed to evaluate the safety and tolerability of SEA-CD70 monotherapy in participants with relapsed\u002Frefractory (HMA-failure) MDS.\n* Part C is an expansion cohort designed to evaluate the safety and tolerability of SEA-CD70 monotherapy in participants with relapsed\u002Frefractory AML.\n* Part D contains dose-finding\u002Fdose optimization cohorts designed to evaluate the safety\u002Ftolerability and identify the recommended expansion dose of SEA-CD70 in combination with azacitidine in participants with 1) relapsed\u002Frefractory (HMA-failure) MDS or MDS\u002FAML, and 2) previously untreated higher-risk per IPSS-M (Moderate High, High or Very High) MDS or MDS\u002FAML.\n* Part E is an expansion cohort designed to evaluate the safety and tolerability of SEA-CD70 in combination with azacitidine in participants with previously untreated higher-risk per IPSS-M (Moderate High, High, or Very High) MDS or MDS\u002FAML.\n* Part F is an expansion cohort designed to evaluate the safety and tolerability of SEA-CD70 in combination with azacitidine in participants with relapsed\u002Frefractory (HMA-failure) MDS or MDS\u002FAML.\n* Part G will find out how much SEA-CD70 with azacitidine and with venetoclax should be given to participants with previously untreated AML who are unfit for standard of care induction chemotherapy",[85,91,95,99,104,108,112],{"label":86,"type":87,"description":88,"interventionNames":89},"Part A","EXPERIMENTAL","SEA-CD70 dose escalation cohort in relapsed\u002Frefractory (HMA-failure) MDS",[90],"Drug: SEA-CD70",{"label":92,"type":87,"description":93,"interventionNames":94},"Part B","SEA-CD70 expansion cohort in relapsed\u002Frefractory (HMA-failure) MDS",[90],{"label":96,"type":87,"description":97,"interventionNames":98},"Part C","SEA-CD70 expansion cohort in relapsed\u002Frefractory AML",[90],{"label":100,"type":87,"description":101,"interventionNames":102},"Part D","SEA-CD70 + azacitidine dose-finding\u002Fdose optimization cohorts in relapsed\u002Frefractory MDS or MDS\u002FAML, and previously untreated higher-risk MDS or MDS\u002FAML",[90,103],"Drug: azacitidine",{"label":105,"type":87,"description":106,"interventionNames":107},"Part E","SEA-CD70 + azacitidine expansion cohort in previously untreated higher-risk MDS or MDS\u002FAML",[90,103],{"label":109,"type":87,"description":110,"interventionNames":111},"Part F","SEA-CD70 + azacitidine expansion cohort in relapsed\u002Frefractory MDS or MDS\u002FAML",[90,103],{"label":113,"type":87,"description":114,"interventionNames":115},"Part G","SEA-CD70 + azacitidine +venetoclax dose-finding\u002Fdose optimization in previously untreated and unfit for induction therapy AML",[90,103,116],"Drug: Venetoclax",[118,123,129],{"type":119,"name":120,"description":121,"armGroupLabels":122,"otherNames":75},"DRUG","SEA-CD70","Given into the vein (IV; intravenously) on Days 1 and 15 of each treatment cycle",[86,92,96,100,105,109,113],{"type":119,"name":124,"description":125,"armGroupLabels":126,"otherNames":127},"azacitidine","75mg\u002Fm\\^2 injected under the skin (SC; subcutaneous) or given into the vein (IV; intravenously) on Days 1 through 7 of each treatment cycle.",[100,105,109,113],[128],"VIDAZA",{"type":119,"name":130,"description":131,"armGroupLabels":132,"otherNames":133},"Venetoclax","400 mg \u002Fday PO, continuously; administered with ramping",[113],[134],"Venclexta",[136],{"name":137,"affiliation":138,"role":139},"Pfizer CT.gov Call Center","Pfizer","STUDY_DIRECTOR",[141],{"name":137,"role":142,"phone":143,"phoneExt":75,"email":144},"CONTACT","1-800-718-1021","ClinicalTrials.gov_Inquiries@pfizer.com",[146,160,165,171,182,187,196,201,211,216,221,231,236,245,250,255,260,269,275,283,293,299,304,309,319,325,330,340,349,358,363,369,378,387,392,397,407,413,422,432,437,442,447,457,463,468,477,482,492,498,510,515,524,535],{"facility":147,"status":148,"city":149,"state":150,"zip":151,"country":152,"countryCode":153,"cosmosGeoPoint":154,"geoPoint":159,"contacts":75},"University of Alabama at Birmingham","ACTIVE_NOT_RECRUITING","Birmingham","Alabama","35233","United States","US",{"type":155,"coordinates":156},"Point",[157,158],-86.80249,33.52066,{"lat":158,"lon":157},{"facility":147,"status":148,"city":149,"state":150,"zip":161,"country":152,"countryCode":153,"cosmosGeoPoint":162,"geoPoint":164,"contacts":75},"35249",{"type":155,"coordinates":163},[157,158],{"lat":158,"lon":157},{"facility":166,"status":148,"city":149,"state":150,"zip":167,"country":152,"countryCode":153,"cosmosGeoPoint":168,"geoPoint":170,"contacts":75},"Dept. of Medicine, UAB ONeal Comprehensive Cancer Center","35294",{"type":155,"coordinates":169},[157,158],{"lat":158,"lon":157},{"facility":172,"status":173,"city":174,"state":175,"zip":176,"country":152,"countryCode":153,"cosmosGeoPoint":177,"geoPoint":181,"contacts":75},"City of Hope (City of Hope National Medical Center, City of Hope Medical Center)","RECRUITING","Duarte","California","91010",{"type":155,"coordinates":178},[179,180],-117.97729,34.13945,{"lat":180,"lon":179},{"facility":183,"status":173,"city":174,"state":175,"zip":176,"country":152,"countryCode":153,"cosmosGeoPoint":184,"geoPoint":186,"contacts":75},"IP Address: City of Hope Investigational Drug Services(IDS)",{"type":155,"coordinates":185},[179,180],{"lat":180,"lon":179},{"facility":188,"status":173,"city":189,"state":175,"zip":190,"country":152,"countryCode":153,"cosmosGeoPoint":191,"geoPoint":195,"contacts":75},"Ronald Reagan UCLA Medical Center","Los Angeles","90095",{"type":155,"coordinates":192},[193,194],-118.24368,34.05223,{"lat":194,"lon":193},{"facility":197,"status":173,"city":189,"state":175,"zip":190,"country":152,"countryCode":153,"cosmosGeoPoint":198,"geoPoint":200,"contacts":75},"UCLA Hematology-Oncology Clinic",{"type":155,"coordinates":199},[193,194],{"lat":194,"lon":193},{"facility":202,"status":148,"city":203,"state":204,"zip":205,"country":152,"countryCode":153,"cosmosGeoPoint":206,"geoPoint":210,"contacts":75},"Colorado Blood Cancer Institute, Lab","Denver","Colorado","80218",{"type":155,"coordinates":207},[208,209],-104.9847,39.73915,{"lat":209,"lon":208},{"facility":212,"status":148,"city":203,"state":204,"zip":205,"country":152,"countryCode":153,"cosmosGeoPoint":213,"geoPoint":215,"contacts":75},"Colorado Blood Cancer Institute",{"type":155,"coordinates":214},[208,209],{"lat":209,"lon":208},{"facility":217,"status":148,"city":203,"state":204,"zip":205,"country":152,"countryCode":153,"cosmosGeoPoint":218,"geoPoint":220,"contacts":75},"Presbyterian\u002FSt. Luke's Medical Center",{"type":155,"coordinates":219},[208,209],{"lat":209,"lon":208},{"facility":222,"status":173,"city":223,"state":224,"zip":225,"country":152,"countryCode":153,"cosmosGeoPoint":226,"geoPoint":230,"contacts":75},"The University of Kansas Cancer Center ,Investigational Drug Services","Fairway","Kansas","66205",{"type":155,"coordinates":227},[228,229],-94.6319,39.02223,{"lat":229,"lon":228},{"facility":232,"status":173,"city":223,"state":224,"zip":225,"country":152,"countryCode":153,"cosmosGeoPoint":233,"geoPoint":235,"contacts":75},"The University of Kansas Clinical Research Center",{"type":155,"coordinates":234},[228,229],{"lat":229,"lon":228},{"facility":237,"status":173,"city":238,"state":224,"zip":239,"country":152,"countryCode":153,"cosmosGeoPoint":240,"geoPoint":244,"contacts":75},"The University of Kansas Hospital","Kansas City","66160",{"type":155,"coordinates":241},[242,243],-94.62746,39.11417,{"lat":243,"lon":242},{"facility":246,"status":173,"city":238,"state":224,"zip":239,"country":152,"countryCode":153,"cosmosGeoPoint":247,"geoPoint":249,"contacts":75},"University of Kansas Hospital Cambridge North Tower A",{"type":155,"coordinates":248},[242,243],{"lat":243,"lon":242},{"facility":251,"status":173,"city":238,"state":224,"zip":239,"country":152,"countryCode":153,"cosmosGeoPoint":252,"geoPoint":254,"contacts":75},"University of Kansas Medical center Medical office building",{"type":155,"coordinates":253},[242,243],{"lat":243,"lon":242},{"facility":256,"status":173,"city":238,"state":224,"zip":239,"country":152,"countryCode":153,"cosmosGeoPoint":257,"geoPoint":259,"contacts":75},"University of Kansas Medical Center Research Institute",{"type":155,"coordinates":258},[242,243],{"lat":243,"lon":242},{"facility":261,"status":173,"city":262,"state":224,"zip":263,"country":152,"countryCode":153,"cosmosGeoPoint":264,"geoPoint":268,"contacts":75},"The University of Kansas Cancer Center - Overland Park","Overland Park","66210",{"type":155,"coordinates":265},[266,267],-94.67079,38.98223,{"lat":267,"lon":266},{"facility":270,"status":173,"city":262,"state":224,"zip":271,"country":152,"countryCode":153,"cosmosGeoPoint":272,"geoPoint":274,"contacts":75},"The University of Kansas Cancer Center - Indian Creek Campus","66211",{"type":155,"coordinates":273},[266,267],{"lat":267,"lon":266},{"facility":276,"status":173,"city":277,"state":224,"zip":225,"country":152,"countryCode":153,"cosmosGeoPoint":278,"geoPoint":282,"contacts":75},"The University of Kansas Cancer Center","Westwood",{"type":155,"coordinates":279},[280,281],-94.6169,39.04056,{"lat":281,"lon":280},{"facility":284,"status":173,"city":285,"state":286,"zip":287,"country":152,"countryCode":153,"cosmosGeoPoint":288,"geoPoint":292,"contacts":75},"Norton Hospitals, Inc","Louisville","Kentucky","40202",{"type":155,"coordinates":289},[290,291],-85.75941,38.25424,{"lat":291,"lon":290},{"facility":294,"status":173,"city":285,"state":286,"zip":295,"country":152,"countryCode":153,"cosmosGeoPoint":296,"geoPoint":298,"contacts":75},"Norton Cancer Institute, St. Matthews Campus, Attn. Becky Champion, PharmD","40207",{"type":155,"coordinates":297},[290,291],{"lat":291,"lon":290},{"facility":300,"status":173,"city":285,"state":286,"zip":295,"country":152,"countryCode":153,"cosmosGeoPoint":301,"geoPoint":303,"contacts":75},"Norton Cancer Institute, St. Matthews Campus",{"type":155,"coordinates":302},[290,291],{"lat":291,"lon":290},{"facility":305,"status":173,"city":285,"state":286,"zip":295,"country":152,"countryCode":153,"cosmosGeoPoint":306,"geoPoint":308,"contacts":75},"Norton Women & Children's Hospital",{"type":155,"coordinates":307},[290,291],{"lat":291,"lon":290},{"facility":310,"status":173,"city":311,"state":312,"zip":313,"country":152,"countryCode":153,"cosmosGeoPoint":314,"geoPoint":318,"contacts":75},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":155,"coordinates":315},[316,317],-71.05977,42.35843,{"lat":317,"lon":316},{"facility":320,"status":173,"city":311,"state":312,"zip":321,"country":152,"countryCode":153,"cosmosGeoPoint":322,"geoPoint":324,"contacts":75},"Beth Israel Deaconess Medical Center","02215",{"type":155,"coordinates":323},[316,317],{"lat":317,"lon":316},{"facility":326,"status":173,"city":311,"state":312,"zip":321,"country":152,"countryCode":153,"cosmosGeoPoint":327,"geoPoint":329,"contacts":75},"Dana Farber\u002FMass General Brigham Cancer Care, Inc",{"type":155,"coordinates":328},[316,317],{"lat":317,"lon":316},{"facility":331,"status":173,"city":332,"state":333,"zip":334,"country":152,"countryCode":153,"cosmosGeoPoint":335,"geoPoint":339,"contacts":75},"Karmanos Cancer Institute","Detroit","Michigan","48201",{"type":155,"coordinates":336},[337,338],-83.04575,42.33143,{"lat":338,"lon":337},{"facility":341,"status":173,"city":342,"state":333,"zip":343,"country":152,"countryCode":153,"cosmosGeoPoint":344,"geoPoint":348,"contacts":75},"Karmanos Cancer Institute Weisberg Cancer Treatment Center","Farmington Hills","48334",{"type":155,"coordinates":345},[346,347],-83.37716,42.48531,{"lat":347,"lon":346},{"facility":350,"status":173,"city":238,"state":351,"zip":352,"country":152,"countryCode":153,"cosmosGeoPoint":353,"geoPoint":357,"contacts":75},"The University of Kansas Cancer Center - Medical Oncology Clinic","Missouri","64116",{"type":155,"coordinates":354},[355,356],-94.57857,39.09973,{"lat":356,"lon":355},{"facility":359,"status":173,"city":238,"state":351,"zip":352,"country":152,"countryCode":153,"cosmosGeoPoint":360,"geoPoint":362,"contacts":75},"The University of Kansas Cancer Center - Radiation Oncology Clinic",{"type":155,"coordinates":361},[355,356],{"lat":356,"lon":355},{"facility":364,"status":173,"city":238,"state":351,"zip":365,"country":152,"countryCode":153,"cosmosGeoPoint":366,"geoPoint":368,"contacts":75},"The University of Kansas Cancer Center -North","64154",{"type":155,"coordinates":367},[355,356],{"lat":356,"lon":355},{"facility":370,"status":173,"city":371,"state":351,"zip":372,"country":152,"countryCode":153,"cosmosGeoPoint":373,"geoPoint":377,"contacts":75},"The University of Kansas Cancer Center - Lee's Summit","Lee's Summit","64064",{"type":155,"coordinates":374},[375,376],-94.38217,38.91084,{"lat":376,"lon":375},{"facility":379,"status":173,"city":380,"state":380,"zip":381,"country":152,"countryCode":153,"cosmosGeoPoint":382,"geoPoint":386,"contacts":75},"Columbia University Irving Medical Center","New York","10032",{"type":155,"coordinates":383},[384,385],-74.00597,40.71427,{"lat":385,"lon":384},{"facility":388,"status":173,"city":380,"state":380,"zip":381,"country":152,"countryCode":153,"cosmosGeoPoint":389,"geoPoint":391,"contacts":75},"CUIMC Research Pharmacy",{"type":155,"coordinates":390},[384,385],{"lat":385,"lon":384},{"facility":393,"status":173,"city":380,"state":380,"zip":381,"country":152,"countryCode":153,"cosmosGeoPoint":394,"geoPoint":396,"contacts":75},"The New York and Presbyterian Hospital",{"type":155,"coordinates":395},[384,385],{"lat":385,"lon":384},{"facility":398,"status":173,"city":399,"state":400,"zip":401,"country":152,"countryCode":153,"cosmosGeoPoint":402,"geoPoint":406,"contacts":75},"University Hospitals Cleveland Medical Center","Cleveland","Ohio","44106",{"type":155,"coordinates":403},[404,405],-81.69541,41.4995,{"lat":405,"lon":404},{"facility":408,"status":173,"city":399,"state":400,"zip":409,"country":152,"countryCode":153,"cosmosGeoPoint":410,"geoPoint":412,"contacts":75},"Cleveland Clinic","44195",{"type":155,"coordinates":411},[404,405],{"lat":405,"lon":404},{"facility":414,"status":173,"city":415,"state":400,"zip":416,"country":152,"countryCode":153,"cosmosGeoPoint":417,"geoPoint":421,"contacts":75},"The Ohio State University Wexner Medical Center\u002FJames Cancer Hospital","Columbus","43210",{"type":155,"coordinates":418},[419,420],-82.99879,39.96118,{"lat":420,"lon":419},{"facility":423,"status":173,"city":424,"state":425,"zip":426,"country":152,"countryCode":153,"cosmosGeoPoint":427,"geoPoint":431,"contacts":75},"Hollings Cancer Center","Charleston","South Carolina","29425",{"type":155,"coordinates":428},[429,430],-79.93275,32.77632,{"lat":430,"lon":429},{"facility":433,"status":173,"city":424,"state":425,"zip":426,"country":152,"countryCode":153,"cosmosGeoPoint":434,"geoPoint":436,"contacts":75},"Medical University of South Carolina- Ashley River Tower",{"type":155,"coordinates":435},[429,430],{"lat":430,"lon":429},{"facility":438,"status":173,"city":424,"state":425,"zip":426,"country":152,"countryCode":153,"cosmosGeoPoint":439,"geoPoint":441,"contacts":75},"Medical University of South Carolina- Investigational Drug Services",{"type":155,"coordinates":440},[429,430],{"lat":430,"lon":429},{"facility":443,"status":173,"city":424,"state":425,"zip":426,"country":152,"countryCode":153,"cosmosGeoPoint":444,"geoPoint":446,"contacts":75},"Medical University of South Carolina- University Hospital",{"type":155,"coordinates":445},[429,430],{"lat":430,"lon":429},{"facility":448,"status":173,"city":449,"state":450,"zip":451,"country":152,"countryCode":153,"cosmosGeoPoint":452,"geoPoint":456,"contacts":75},"Baylor Research Institute","Dallas","Texas","75204",{"type":155,"coordinates":453},[454,455],-96.80667,32.78306,{"lat":455,"lon":454},{"facility":458,"status":173,"city":449,"state":450,"zip":459,"country":152,"countryCode":153,"cosmosGeoPoint":460,"geoPoint":462,"contacts":75},"Baylor University Medical Center, Investigational Drug Services, Department of Pharmacy","75246",{"type":155,"coordinates":461},[454,455],{"lat":455,"lon":454},{"facility":464,"status":173,"city":449,"state":450,"zip":459,"country":152,"countryCode":153,"cosmosGeoPoint":465,"geoPoint":467,"contacts":75},"Baylor University Medical Center",{"type":155,"coordinates":466},[454,455],{"lat":455,"lon":454},{"facility":469,"status":173,"city":470,"state":450,"zip":471,"country":152,"countryCode":153,"cosmosGeoPoint":472,"geoPoint":476,"contacts":75},"Houston Methodist Hospital","Houston","77030",{"type":155,"coordinates":473},[474,475],-95.36327,29.76328,{"lat":475,"lon":474},{"facility":478,"status":148,"city":470,"state":450,"zip":471,"country":152,"countryCode":153,"cosmosGeoPoint":479,"geoPoint":481,"contacts":75},"The University of Texas MD Anderson Cancer Center",{"type":155,"coordinates":480},[474,475],{"lat":475,"lon":474},{"facility":483,"status":173,"city":484,"state":485,"zip":486,"country":152,"countryCode":153,"cosmosGeoPoint":487,"geoPoint":491,"contacts":75},"Swedish Cancer Institute","Seattle","Washington","98104",{"type":155,"coordinates":488},[489,490],-122.33207,47.60621,{"lat":490,"lon":489},{"facility":493,"status":173,"city":484,"state":485,"zip":494,"country":152,"countryCode":153,"cosmosGeoPoint":495,"geoPoint":497,"contacts":75},"Swedish Medical Center","98122",{"type":155,"coordinates":496},[489,490],{"lat":490,"lon":489},{"facility":499,"status":173,"city":500,"state":501,"zip":502,"country":503,"countryCode":504,"cosmosGeoPoint":505,"geoPoint":509,"contacts":75},"National Cancer Center Hospital East","Kashiwa","Chiba","277-8577","Japan","JP",{"type":155,"coordinates":506},[507,508],139.97732,35.86224,{"lat":508,"lon":507},{"facility":511,"status":173,"city":512,"state":513,"zip":514,"country":503,"countryCode":504,"cosmosGeoPoint":75,"geoPoint":75,"contacts":75},"Nippon Medical School Hospital","Bunkyo-ku","Tokyo","113-8603",{"facility":516,"status":173,"city":517,"state":75,"zip":518,"country":503,"countryCode":504,"cosmosGeoPoint":519,"geoPoint":523,"contacts":75},"Yamagata University Hospital","Yamagata","990-9585",{"type":155,"coordinates":520},[521,522],140.36667,38.23333,{"lat":522,"lon":521},{"facility":525,"status":173,"city":526,"state":75,"zip":527,"country":528,"countryCode":529,"cosmosGeoPoint":530,"geoPoint":534,"contacts":75},"Pharmacy - UMC Utrecht t.a.v. Apotheek KGO","Utrecht","3584 CW","Netherlands","NL",{"type":155,"coordinates":531},[532,533],5.12222,52.09083,{"lat":533,"lon":532},{"facility":536,"status":173,"city":526,"state":75,"zip":537,"country":528,"countryCode":529,"cosmosGeoPoint":538,"geoPoint":540,"contacts":75},"University Medical Center (UMC) Utrecht","3584 CX",{"type":155,"coordinates":539},[532,533],{"lat":533,"lon":532},{"type":542,"investigatorFullName":75,"investigatorTitle":75,"investigatorAffiliation":75,"oldNameTitle":75,"oldOrganization":75},"SPONSOR","100379997",false,"NCT04227847","A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies","A Phase 1 Study of SEA-CD70 in Myeloid Malignancies","Part A Inclusion Criteria\n\n* Participants with cytologically\u002Fhistologically confirmed MDS (2016 World Health Organization (WHO) classification) with\n\n  * Measurable disease per WHO MDS with excess blasts criteria\n  * MDS that is relapsed or refractory and must not have other therapeutic options\n  * Treatment failure after prior hypomethylating agent (HMA) therapy for MDS\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n\nPart B Inclusion Criteria\n\n* Participants with cytologically\u002Fhistologically confirmed MDS (WHO classification) with:\n\n  * Measurable disease per WHO MDS with excess blasts (MDS-EB) criteria\n  * MDS that is relapsed or refractory and must not have other therapeutic options\n  * Treatment failure after prior HMA therapy for MDS\n* ECOG Performance Status of 0-2\n\nPart C Inclusion Criteria\n\n* Participants with relapsed or refractory AML (ICC 2022) (except for acute promyelocytic leukemia \\[APL\\]):\n\n  * Who have received either 2 or 3 previous regimens\n  * Who have received 1 previous regimen to treat active disease and have at least one of the following:\n\n    * Age \\> 60 and ≤75 years.\n    * Primary resistant AML or secondary AML\n    * First CR duration \\\u003C6 months\n    * Adverse-risk per European Leukemia Network genetic risk stratification\n* Age 18-75 years\n* ECOG performance status of 0-2\n\nParts D and F Inclusion Criteria\n\n* Participants with diagnosis of MDS or MDS\u002FAML (ICC 2022 criteria)\n* Disease which has relapsed, failed to respond after minimum of 6 cycles, or progressed following an HMA in the immediately preceding line of therapy.\n* Eligible for continued therapy with azacitidine\n* ECOG Performance Status 0-2\n\nParts D and E Inclusion Criteria\n\n* Participants with diagnosis of MDS or MDS\u002FAML (ICC 2022 criteria), previously untreated.\n* Participants with higher-risk per IPSS-M MDS and MDS\u002FAML\n* ECOG Performance Status 0-2\n\nPart G Inclusion Criteria\n\n* Participants with diagnosis of AML (ICC 2022 criteria), previously untreated and ineligible for standard induction chemotherapy.\n* Age ≥18 years.\n* ECOG Performance Status of 0-2.\n\nExclusion Criteria (All Parts)\n\n* Previous exposure to CD70-targeted agents\n* Prior allogeneic hematopoietic stem cell transplant, for any condition\n* Central nervous system leukemia\n* History of clinically significant sickle cell anemia, autoimmune hemolytic anemia, or idiopathic thrombocytopenic purpura\n* Parts D, F and G only: Prior oral HMA or oral HMA-combinations\n* Part G: conditions that preclude enteral route of administration; concomitant use of strong\u002Fmoderate CYP3A inducers; history of myeloproliferative neoplasm","ALL","18 Years",{"count":552,"type":553},178,"ESTIMATED","INTERVENTIONAL",[556],"PHASE1","This trial will look at a drug called SEA-CD70 with and without azacitidine, to find out if it is safe for participants with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). It will study SEA-CD70 to find out what its side effects are and if it works for AML and MDS. A side effect is anything the drug does besides treating cancer.\n\nThis study will have seven groups or \"parts.\"\n\n* Part A will find out how much SEA-CD70 should be given to participants\n* Part B will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat participants with MDS.\n* Part C will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat participants with AML.\n* Part D will find out how much SEA-CD70 with azacitidine should be given to participants\n* Part E will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat participants with MDS or MDS\u002FAML that has not been treated.\n* Part F will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat participants with MDS or MDS\u002FAML.\n* Part G will find out how much SEA-CD70 with azacitidine and with venetoclax should be given to participants with AML. Also, to evaluate safety and tolerability of PF-08046040 in combination with azacitidine and venetoclax in participants with previously untreated AML who are unfit for standard induction chemotherapy.",[559,560],"Myelodysplastic Syndrome","Acute Myeloid Leukemia",[562],"Seattle Genetics","2026-04-06",{"date":565,"type":566},"2026-04-07","ACTUAL",{"date":568,"type":566},"2020-08-07",{"date":570,"type":553},"2028-07-03",{"name":572,"class":6},"Seagen, a wholly owned subsidiary of Pfizer",54]