[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100432511":3},{"organization":4,"armGroups":7,"interventions":40,"overallOfficials":63,"centralContacts":53,"locations":67,"responsibleParty":345,"collaborators":53,"id":347,"slug":348,"hasResults":349,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":53,"eligibilityCriteria":353,"healthyVolunteers":349,"sex":354,"minAge":355,"maxAge":53,"enrollmentInfo":356,"targetDuration":53,"studyType":359,"phases":360,"briefSummary":362,"conditions":363,"keywords":366,"overallStatus":370,"whyStopped":371,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":380},{"fullName":5,"class":6},"AbbVie","INDUSTRY",[8,16,20,24,28,32,36],{"label":9,"type":10,"description":11,"interventionNames":12},"Lemzoparlimab + Azacitidine + Venetoclax in AML (Escalation)","EXPERIMENTAL","Lemzoparlimab (TJ011133) co-administered with azacitidine and venetoclax in escalated doses in participants with treatment-naïve acute myeloid leukemia (AML) who are ineligible for standard induction therapy.",[13,14,15],"Drug: Lemzoparlimab","Drug: Azacitidine","Drug: Venetoclax",{"label":17,"type":10,"description":18,"interventionNames":19},"Lemzoparlimab + Azacitidine + Venetoclax in MDS (Escalation)","Lemzoparlimab (TJ011133) co-administered with azacitidine and venetoclax in escalated doses in participants with treatment-naïve higher-risk myelodysplastic syndrome (MDS).",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"Lemzoparlimab + Azacitidine in MDS (Escalation)","Lemzoparlimab (TJ011133) co-administered with azacitidine in escalated doses in participants with treatment-naïve higher-risk myelodysplastic syndrome (MDS).",[13,14],{"label":25,"type":10,"description":26,"interventionNames":27},"Lemzoparlimab + Azacitidine + Venetoclax in AML (Expansion)","Lemzoparlimab (TJ011133) co-administered with azacitidine and venetoclax in expansion cohort in participants with treatment-naïve acute myeloid leukemia (AML) who are ineligible for standard induction therapy.",[13,14,15],{"label":29,"type":10,"description":30,"interventionNames":31},"Lemzoparlimab + Azacitidine + Venetoclax in MDS (Expansion)","Lemzoparlimab (TJ011133) co-administered with azacitidine and venetoclax in expansion cohort in participants with treatment-naïve higher-risk myelodysplastic syndrome (MDS).",[13,14,15],{"label":33,"type":10,"description":34,"interventionNames":35},"Lemzoparlimab Monotherapy in AML (Japan Only Escalation)","Lemzoparlimab (TJ011133) administered in escalated doses in participants with treatment-naïve acute myeloid leukemia (AML) who are ineligible for standard induction therapy.",[13],{"label":37,"type":10,"description":38,"interventionNames":39},"Lemzoparlimab Monotherapy in MDS (Japan Only Escalation)","Lemzoparlimab (TJ011133) administered in escalated doses in participants with treatment-naïve higher-risk myelodysplastic syndrome (MDS).",[13],[41,49,54],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"DRUG","Lemzoparlimab","Intravenous (IV) Infusion",[9,25,17,29,21,33,37],[47,48],"TJ011133","ABBV-IMAB-TJC4",{"type":42,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"Azacitidine","Subcutaneous Injection or Intravenous (IV) Injection\u002FInfusion",[9,25,17,29,21],null,{"type":42,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"Venetoclax","Oral Tablet",[9,25,17,29],[59,60,61,62],"Venclexta","Venclyxto","ABT-199","GDC-0199",[64],{"name":65,"affiliation":5,"role":66},"ABBVIE INC.","STUDY_DIRECTOR",[68,81,91,101,107,117,127,136,146,156,168,178,190,200,209,218,229,239,247,256,268,277,286,293,298,307,316,327,336],{"facility":69,"status":53,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":53},"University of Alabama at Birmingham - Main \u002FID# 227071","Birmingham","Alabama","35233","United States","US",{"type":76,"coordinates":77},"Point",[78,79],-86.80249,33.52066,{"lat":79,"lon":78},{"facility":82,"status":53,"city":83,"state":84,"zip":85,"country":73,"countryCode":74,"cosmosGeoPoint":86,"geoPoint":90,"contacts":53},"Norton Cancer Institute - St Matthews \u002FID# 228378","Louisville","Kentucky","40207",{"type":76,"coordinates":87},[88,89],-85.75941,38.25424,{"lat":89,"lon":88},{"facility":92,"status":53,"city":93,"state":94,"zip":95,"country":73,"countryCode":74,"cosmosGeoPoint":96,"geoPoint":100,"contacts":53},"Massachusetts General Hospital \u002FID# 227273","Boston","Massachusetts","02114",{"type":76,"coordinates":97},[98,99],-71.05977,42.35843,{"lat":99,"lon":98},{"facility":102,"status":53,"city":93,"state":94,"zip":103,"country":73,"countryCode":74,"cosmosGeoPoint":104,"geoPoint":106,"contacts":53},"Beth Israel Deaconess Medical Center \u002FID# 231083","02215-5400",{"type":76,"coordinates":105},[98,99],{"lat":99,"lon":98},{"facility":108,"status":53,"city":109,"state":110,"zip":111,"country":73,"countryCode":74,"cosmosGeoPoint":112,"geoPoint":116,"contacts":53},"University of Michigan \u002FID# 227030","Ann Arbor","Michigan","48109",{"type":76,"coordinates":113},[114,115],-83.74088,42.27756,{"lat":115,"lon":114},{"facility":118,"status":53,"city":119,"state":120,"zip":121,"country":73,"countryCode":74,"cosmosGeoPoint":122,"geoPoint":126,"contacts":53},"University of Pennsylvania \u002FID# 227024","Philadelphia","Pennsylvania","19104",{"type":76,"coordinates":123},[124,125],-75.16362,39.95238,{"lat":125,"lon":124},{"facility":128,"status":53,"city":129,"state":120,"zip":130,"country":73,"countryCode":74,"cosmosGeoPoint":131,"geoPoint":135,"contacts":53},"UPMC Hillman Cancer Ctr \u002FID# 228048","Pittsburgh","15232",{"type":76,"coordinates":132},[133,134],-79.99589,40.44062,{"lat":134,"lon":133},{"facility":137,"status":53,"city":138,"state":139,"zip":140,"country":73,"countryCode":74,"cosmosGeoPoint":141,"geoPoint":145,"contacts":53},"MD Anderson Cancer Center at Texas Medical Center \u002FID# 227019","Houston","Texas","77030-4000",{"type":76,"coordinates":142},[143,144],-95.36327,29.76328,{"lat":144,"lon":143},{"facility":147,"status":53,"city":148,"state":149,"zip":150,"country":73,"countryCode":74,"cosmosGeoPoint":151,"geoPoint":155,"contacts":53},"University of Virginia Health \u002FID# 227363","Charlottesville","Virginia","22908",{"type":76,"coordinates":152},[153,154],-78.47668,38.02931,{"lat":154,"lon":153},{"facility":157,"status":53,"city":158,"state":159,"zip":160,"country":161,"countryCode":162,"cosmosGeoPoint":163,"geoPoint":167,"contacts":53},"Liverpool Hospital \u002FID# 227723","Liverpool","New South Wales","2170","Australia","AU",{"type":76,"coordinates":164},[165,166],150.92588,-33.91938,{"lat":166,"lon":165},{"facility":169,"status":53,"city":170,"state":171,"zip":172,"country":161,"countryCode":162,"cosmosGeoPoint":173,"geoPoint":177,"contacts":53},"Austin Health \u002FID# 227717","Heidelberg","Victoria","3084",{"type":76,"coordinates":174},[175,176],145.06667,-37.75,{"lat":176,"lon":175},{"facility":179,"status":53,"city":180,"state":181,"zip":182,"country":183,"countryCode":184,"cosmosGeoPoint":185,"geoPoint":189,"contacts":53},"Marien Hospital Duesseldorf \u002FID# 227751","Düsseldorf","North Rhine-Westphalia","40479","Germany","DE",{"type":76,"coordinates":186},[187,188],6.77927,51.22319,{"lat":188,"lon":187},{"facility":191,"status":53,"city":192,"state":193,"zip":194,"country":183,"countryCode":184,"cosmosGeoPoint":195,"geoPoint":199,"contacts":53},"Universitaetsklinikum Leipzig \u002FID# 227750","Leipzig","Saxony","04103",{"type":76,"coordinates":196},[197,198],12.37129,51.33962,{"lat":198,"lon":197},{"facility":201,"status":53,"city":202,"state":53,"zip":203,"country":183,"countryCode":184,"cosmosGeoPoint":204,"geoPoint":208,"contacts":53},"Universitaetsklinikum Carl Gustav Carus an der TU Dresden \u002FID# 227749","Dresden","01307",{"type":76,"coordinates":205},[206,207],13.73832,51.05089,{"lat":207,"lon":206},{"facility":210,"status":53,"city":211,"state":53,"zip":212,"country":183,"countryCode":184,"cosmosGeoPoint":213,"geoPoint":217,"contacts":53},"Universitaetsklinikum Hamburg-Eppendorf (UKE) \u002FID# 227748","Hamburg","20246",{"type":76,"coordinates":214},[215,216],9.99302,53.55073,{"lat":216,"lon":215},{"facility":219,"status":53,"city":220,"state":220,"zip":221,"country":222,"countryCode":223,"cosmosGeoPoint":224,"geoPoint":228,"contacts":53},"Hadassah Medical Center-Hebrew University \u002FID# 227275","Jerusalem","91120","Israel","IL",{"type":76,"coordinates":225},[226,227],35.21633,31.76904,{"lat":227,"lon":226},{"facility":230,"status":53,"city":231,"state":232,"zip":233,"country":222,"countryCode":223,"cosmosGeoPoint":234,"geoPoint":238,"contacts":53},"The Chaim Sheba Medical Center \u002FID# 227389","Ramat Gan","Tel Aviv","5265601",{"type":76,"coordinates":235},[236,237],34.81065,32.08227,{"lat":237,"lon":236},{"facility":240,"status":53,"city":232,"state":232,"zip":241,"country":222,"countryCode":223,"cosmosGeoPoint":242,"geoPoint":246,"contacts":53},"Tel Aviv Sourasky Medical Center \u002FID# 227387","6423906",{"type":76,"coordinates":243},[244,245],34.78057,32.08088,{"lat":245,"lon":244},{"facility":248,"status":53,"city":249,"state":53,"zip":250,"country":222,"countryCode":223,"cosmosGeoPoint":251,"geoPoint":255,"contacts":53},"Rabin Medical Center \u002FID# 227738","Petah Tikva","4941492",{"type":76,"coordinates":252},[253,254],34.88747,32.08707,{"lat":254,"lon":253},{"facility":257,"status":53,"city":258,"state":259,"zip":260,"country":261,"countryCode":262,"cosmosGeoPoint":263,"geoPoint":267,"contacts":53},"Istituto Clinico Humanitas \u002FID# 226948","Rozzano","Milano","20089","Italy","IT",{"type":76,"coordinates":264},[265,266],9.1559,45.38193,{"lat":266,"lon":265},{"facility":269,"status":53,"city":270,"state":53,"zip":271,"country":261,"countryCode":262,"cosmosGeoPoint":272,"geoPoint":276,"contacts":53},"IRCCS Azienda Ospedaliero-Universitaria di Bologna \u002FID# 226950","Bologna","40138",{"type":76,"coordinates":273},[274,275],11.33875,44.49381,{"lat":275,"lon":274},{"facility":278,"status":53,"city":279,"state":53,"zip":280,"country":261,"countryCode":262,"cosmosGeoPoint":281,"geoPoint":285,"contacts":53},"ASST Grande Ospedale Metropolitano Niguarda \u002FID# 226952","Milan","20162",{"type":76,"coordinates":282},[283,284],12.59836,42.78235,{"lat":284,"lon":283},{"facility":287,"status":53,"city":288,"state":289,"zip":290,"country":291,"countryCode":292,"cosmosGeoPoint":53,"geoPoint":53,"contacts":53},"National Cancer Center Hospital East \u002FID# 232498","Kashiwa-shi","Chiba","277-8577","Japan","JP",{"facility":294,"status":53,"city":295,"state":296,"zip":297,"country":291,"countryCode":292,"cosmosGeoPoint":53,"geoPoint":53,"contacts":53},"University of Fukui Hospital \u002FID# 232466","Yoshida-gun","Fukui","910-1193",{"facility":299,"status":53,"city":300,"state":300,"zip":301,"country":291,"countryCode":292,"cosmosGeoPoint":302,"geoPoint":306,"contacts":53},"Kyushu University Hospital \u002FID# 232564","Fukuoka","812-8582",{"type":76,"coordinates":303},[304,305],130.41667,33.6,{"lat":305,"lon":304},{"facility":308,"status":53,"city":309,"state":309,"zip":310,"country":291,"countryCode":292,"cosmosGeoPoint":311,"geoPoint":315,"contacts":53},"Yamagata University Hospital \u002FID# 232451","Yamagata","990-9585",{"type":76,"coordinates":312},[313,314],140.36667,38.23333,{"lat":314,"lon":313},{"facility":317,"status":53,"city":318,"state":53,"zip":319,"country":320,"countryCode":321,"cosmosGeoPoint":322,"geoPoint":326,"contacts":53},"Hospital Clinic de Barcelona \u002FID# 227772","Barcelona","08036","Spain","ES",{"type":76,"coordinates":323},[324,325],2.15899,41.38879,{"lat":325,"lon":324},{"facility":328,"status":53,"city":329,"state":53,"zip":330,"country":320,"countryCode":321,"cosmosGeoPoint":331,"geoPoint":335,"contacts":53},"Hospital Universitario Fundacion Jimenez Diaz \u002FID# 227771","Madrid","28040",{"type":76,"coordinates":332},[333,334],-3.70256,40.4165,{"lat":334,"lon":333},{"facility":337,"status":53,"city":338,"state":53,"zip":339,"country":320,"countryCode":321,"cosmosGeoPoint":340,"geoPoint":344,"contacts":53},"Hospital Universitario Virgen de la Victoria \u002FID# 227770","Málaga","29010",{"type":76,"coordinates":341},[342,343],-4.42034,36.72016,{"lat":343,"lon":342},{"type":346,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR","100432511","phase-1-study-to-evaluate-adverse-events-and-movement-of-lemzoparlimab-in-body-when-used-intravenously-iv-with-azacitidine-subcutaneously-or-iv-and-venetoclax-orally-in-participants-with-acute-myeloid-leukemia-and-with-azacitidine-with-or-without-venetoclax-in-participants-with-myelodysplastic-syndrome-100432511",false,"NCT04912063","Study to Evaluate Adverse Events and Movement of Lemzoparlimab in Body When Used Intravenously (IV) With Azacitidine Subcutaneously or IV and Venetoclax Orally in Participants With Acute Myeloid Leukemia and With Azacitidine With or Without Venetoclax in Participants With Myelodysplastic Syndrome","A Phase 1b Dose Escalation Study of Lemzoparlimab in Combination With Venetoclax and\u002For Azacitidine in Subjects With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)","Inclusion Criteria:\n\n* Documented confirmation of acute myeloid leukemia (AML) according to the World Health Organization (WHO) criteria, previously untreated \\[OR\\]\n* Documented diagnosis of previously untreated de novo myelodysplastic syndrome (MDS) according to the 2017 WHO classification with presence of \\\u003C 20% bone marrow blasts per marrow biopsy\u002Faspirate.\n* Participants with documented MDS must meet the following disease activity criteria:\n\n  * Overall revised international prognostic scoring system (IPSS-R) score \\> 3 (intermediate, high, or very high);\n  * Eastern cooperative oncology group (ECOG) performance status of 0 to 2;\n  * Hematopoietic stem cell transplant (HSCT) ineligible, or participant who chooses not to undergo HSCT.\n* Participants with documented AML with adverse cytogenetic and\u002For molecular risk, and must be considered ineligible for induction therapy defined by the following:\n\n  * \\>= 75 years of age; \\[OR\\]\n  * \\>= 18 to 74 years of age with at least one of the following comorbidities: --- Eastern cooperative oncology group (ECOG) performance status of 2 to 3; --- Cardiac history of congestive heart failure requiring treatment or ejection fraction \\\u003C= 50% or chronic stable angina;\n\n    * Diffusion capacity of lung (DLCO) \\\u003C= 65% or forced expiratory volume during the first second (FEV1) \\\u003C= 65%;\n    * Creatinine clearance \\>= 30 mL\u002Fmin to \\\u003C 45 mL\u002Fmin;\n    * Moderate hepatic impairment with total bilirubin \\> 1.5 to \\\u003C= 3.0 × upper limit of normal (ULN);\n    * Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy or the participant declines to receive intensive chemotherapy.\n\nJapan Safety Lead-In Phase:\n\n* Documented confirmation of AML according to WHO criteria, relapsed or refractory (R\u002FR) disease without other standard of care treatments.\n* Documented diagnosis of MDS according to the 2017 WHO classification with presence of \\\u003C 20% bone marrow blasts per marrow biopsy\u002Faspirate, with intermediate- and high-risk relapsed\u002Frefractory MDS.\n* Documented MDS must meet the following disease activity criteria:\n\n  * ECOG performance status of 0 to 2.\n\nExclusion Criteria:\n\n* Participants with documented AML with acute promyelocytic leukemia and considered eligible for induction therapy.\n* Participant with documented AML having prior diagnosis of:\n\n  \\-- known active central nervous system involvement with AML.\n* Participants with documented MDS having prior diagnosis of:\n\n  * MDS evolving from a pre-existing myeloproliferative neoplasm (MPN);\n  * MDS\u002FMPN including chronic myelomonocytic leukemia, atypical chronic myeloid leukemia, juvenile myelomonocytic leukemia and unclassifiable MDS\u002FMPN.\n* History of allogeneic HSCT or solid organ transplantation.\n* Previous exposure to anti-CD47 therapies.\n* History of an active malignancy within the past 2 years prior to Screening, with the exception of:\n\n  \\-- Adequately treated carcinoma in situ of the cervix uteri or carcinoma in situ of the breast;\n  * Adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin;\n  * Asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy;\n  * Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.\n* Conditions that could interfere with drug absorption including but not limited to short bowel syndrome.\n\nJapan Safety Lead-In Phase:\n\n* Documented AML have Acute Promyelocytic Leukemia.\n* Participant with documented AML having prior diagnosis of:\n\n  \\-- Chronic myeloid leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.\n* Participants with documented MDS having prior diagnosis of:\n\n  * Therapy-related MDS.","ALL","18 Years",{"count":357,"type":358},40,"ACTUAL","INTERVENTIONAL",[361],"PHASE1","Acute myeloid leukemia (AML) is one of the most aggressive blood cancers, with a very low survival rate and few options for participants who are unable to undergo intensive chemotherapy, the current standard of care. This study is to evaluate how safe lemzoparlimab is and how it moves within the body when used along with azacitidine and\u002For venetoclax in adult participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Adverse events and maximum tolerated dose (MTD) of lemzoparlimab will be assessed.\n\nLemzoparlimab (TJ011133) is being evaluated in combination with azacitidine and venetoclax for the treatment of acute myeloid leukemia (AML) and with azacitidine with\u002Fwithout venetoclax for myelodysplastic syndrome (MDS). Study doctors place the participants in 1 of 5 groups, called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of AML or MDS will be enrolled. Around 80 participants will be enrolled in the study in approximately 50 sites worldwide.\n\nParticipants will receive lemzoparlimab (IV) once weekly (Q1W), venetoclax oral tablets once daily (QD) for 28 days (AML participants) or 14 days (MDS participants) and Azacitidine by SC or IV route QD for 7 days of each 28-day cycle.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects.",[364,365],"Acute Myeloid Leukemia (AML)","Myelodysplastic Syndrome (MDS)",[364,365,43,47,48,55,61,62,367,368,50,369],"VENCLEXTA","VENCLYXTO","Cancer","TERMINATED","Strategic considerations","2024-02-23",{"date":374,"type":358},"2024-02-26",{"date":376,"type":358},"2021-06-25",{"date":378,"type":358},"2023-05-09",{"name":5,"class":6},29]