[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100400967":3},{"organization":4,"armGroups":7,"interventions":46,"overallOfficials":72,"centralContacts":81,"locations":86,"responsibleParty":240,"collaborators":242,"id":244,"slug":245,"hasResults":246,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":52,"eligibilityCriteria":250,"healthyVolunteers":246,"sex":251,"minAge":252,"maxAge":52,"enrollmentInfo":253,"targetDuration":52,"studyType":256,"phases":257,"briefSummary":260,"conditions":261,"keywords":264,"overallStatus":89,"whyStopped":52,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":276},{"fullName":5,"class":6},"Ascentage Pharma Group Inc.","INDUSTRY",[8,14,19,24,29,33,37,42],{"label":9,"type":10,"description":11,"interventionNames":12},"Lisaftoclax (APG-2575) single agent","EXPERIMENTAL","Lisaftoclax (APG-2575) orally once daily starting from 200mg and will be increased in subsequent cohorts to 400mg, 600mg, 800mg, to determine the MTD\u002FRP2D.",[13],"Drug: Lisaftoclax (APG-2575)",{"label":15,"type":10,"description":16,"interventionNames":17},"Lisaftoclax (APG-2575)+reduced-dose HHT","Lisaftoclax (APG-2575) MTD\u002FRP2D-1 and MTD\u002FRP2D combines with reduced-dose HHT in R\u002FR AML, MPAL, BPDCN, CMML.",[13,18],"Drug: Reduced-dose HHT",{"label":20,"type":10,"description":21,"interventionNames":22},"Lisaftoclax (APG-2575)+ standard-dose HHT","Lisaftoclax (APG-2575) MTD\u002FRP2D-1 and MTD\u002FRP2D combines with standard-dose HHT in R\u002FR AML, MPAL, BPDCN, CMML.",[13,23],"Drug: standard-dose HHT",{"label":25,"type":10,"description":26,"interventionNames":27},"Lisaftoclax (APG-2575)+ AZA","Lisaftoclax (APG-2575) MTD\u002FRP2D-1 and MTD\u002FRP2D combines with AZA in R\u002FR AML, MPAL, BPDCN, CMML.",[13,28],"Drug: Azacitidine",{"label":30,"type":10,"description":31,"interventionNames":32},"Lisaftoclax (APG-2575)+ AZA(HR-MDS.)","Lisaftoclax (APG-2575) MTD\u002FRP2D-1 and MTD\u002FRP2D combines with AZA in HR-MDS.",[28,13],{"label":34,"type":10,"description":35,"interventionNames":36},"Lisaftoclax (APG-2575)+ AZA(Naïve AML.)","Lisaftoclax (APG-2575) MTD\u002FRP2D-1 and MTD\u002FRP2D combines with AZA in treatment naïve AML.",[13,28],{"label":38,"type":10,"description":39,"interventionNames":40},"Lisaftoclax (APG-2575)+AZA+Olverembatinib","Lisaftoclax (APG-2575) combines with AZA and Olverembatinib in R\u002FR AML.",[28,13,41],"Drug: olverembatinib",{"label":43,"type":10,"description":44,"interventionNames":45},"Lisaftoclax (APG-2575)+HHT+Olverembatinib","Lisaftoclax (APG-2575) combines with HHT and Olverembatinib in R\u002FR AML.",[23,13,41],[47,53,57,61,65,68],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"DRUG","Lisaftoclax (APG-2575)","Lisaftoclax (APG-2575) orally once daily, every 28 days as a cycle.",[9,25,34,20,15],null,{"type":48,"name":54,"description":55,"armGroupLabels":56,"otherNames":52},"Reduced-dose HHT","1mg IV QD on Days 1-14 (28-day cycle).",[15],{"type":48,"name":58,"description":59,"armGroupLabels":60,"otherNames":52},"standard-dose HHT","2mg\u002Fm\\^2 IV QD on Days 1-7 (28-day cycle).",[20,43],{"type":48,"name":62,"description":63,"armGroupLabels":64,"otherNames":52},"Azacitidine","75 mg\u002Fm\\^2 SC or Iv gtt QD on Days 1- 7 (28-day cycle).",[25,30,34,38],{"type":48,"name":49,"description":66,"armGroupLabels":67,"otherNames":52},"Lisaftoclax (APG-2575) orally once daily for 14 days, every 28 days as a cycle.",[30,38,43],{"type":48,"name":69,"description":70,"armGroupLabels":71,"otherNames":52},"olverembatinib","orally, with meals, QOD, every 28 days as a cycle.",[38,43],[73,77],{"name":74,"affiliation":75,"role":76},"Yifan Zhai, M.D., Ph.D.","Suzhou Yasheng Pharmaceutical Co., Ltd.","STUDY_DIRECTOR",{"name":78,"affiliation":79,"role":80},"Jie Jin, M.D.","the First Affiliated Hospital, College of Medicine","PRINCIPAL_INVESTIGATOR",[82],{"name":78,"role":83,"phone":84,"phoneExt":52,"email":85},"CONTACT","+86 571-87236896","jiej0503@163.com",[87,104,117,129,139,151,164,175,189,201,213,228],{"facility":88,"status":89,"city":90,"state":91,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"Peking University People's Hospital","RECRUITING","Beijing","Beijing Municipality","100044","China","CN",{"type":96,"coordinates":97},"Point",[98,99],116.39723,39.9075,{"lat":99,"lon":98},[102],{"name":103,"role":83,"phone":52,"phoneExt":52,"email":52},"Qiang Jiang, Professor",{"facility":105,"status":106,"city":107,"state":108,"zip":52,"country":93,"countryCode":94,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Chongqing University Cancer Hospital","NOT_YET_RECRUITING","Chongqing","Chongqing Municipality",{"type":96,"coordinates":110},[111,112],106.55771,29.56026,{"lat":112,"lon":111},[115],{"name":116,"role":83,"phone":52,"phoneExt":52,"email":52},"Yi Gong, M.D.",{"facility":118,"status":89,"city":119,"state":120,"zip":52,"country":93,"countryCode":94,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Sun Yat-sen University Cancer Center","Guangzhou","Guandong",{"type":96,"coordinates":122},[123,124],113.25,23.11667,{"lat":124,"lon":123},[127],{"name":128,"role":83,"phone":52,"phoneExt":52,"email":52},"Yang Liang, Professor",{"facility":130,"status":89,"city":119,"state":131,"zip":132,"country":93,"countryCode":94,"cosmosGeoPoint":133,"geoPoint":135,"contacts":136},"Guangdong Provincial People's Hospital","Guangdong","510080",{"type":96,"coordinates":134},[123,124],{"lat":124,"lon":123},[137],{"name":138,"role":83,"phone":52,"phoneExt":52,"email":52},"Jianyu Wong, 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university","430071",{"type":96,"coordinates":168},[158,159],{"lat":159,"lon":158},[171,173],{"name":172,"role":83,"phone":52,"phoneExt":52,"email":52},"Fuling Zhou, Professor",{"name":174,"role":83,"phone":52,"phoneExt":52,"email":52},"Jianying Zhou, Professor",{"facility":176,"status":89,"city":177,"state":178,"zip":52,"country":93,"countryCode":94,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"Xiangya Hospital Central South University","Changsha","Hunan",{"type":96,"coordinates":180},[181,182],112.97087,28.19874,{"lat":182,"lon":181},[185,187],{"name":186,"role":83,"phone":52,"phoneExt":52,"email":52},"Yajing Xu, Master",{"name":188,"role":83,"phone":52,"phoneExt":52,"email":52},"Qun He, Master",{"facility":190,"status":89,"city":191,"state":192,"zip":52,"country":93,"countryCode":94,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"The First affiliated hospital of Soochow University","Suzhou","Jiangsu",{"type":96,"coordinates":194},[195,196],120.59538,31.30408,{"lat":196,"lon":195},[199],{"name":200,"role":83,"phone":52,"phoneExt":52,"email":52},"Suning Chen, M.D.",{"facility":202,"status":106,"city":203,"state":204,"zip":52,"country":93,"countryCode":94,"cosmosGeoPoint":205,"geoPoint":209,"contacts":210},"Shanghai The Sixth People' s Hospital","Shanghai","Shanghai Municipality",{"type":96,"coordinates":206},[207,208],121.45806,31.22222,{"lat":208,"lon":207},[211],{"name":212,"role":83,"phone":52,"phoneExt":52,"email":52},"Chunkang Chang, Professor",{"facility":214,"status":89,"city":215,"state":216,"zip":217,"country":93,"countryCode":94,"cosmosGeoPoint":218,"geoPoint":222,"contacts":223},"West China Hospital of Sichuan University","Chengdu","Sichuan","610044",{"type":96,"coordinates":219},[220,221],104.06667,30.66667,{"lat":221,"lon":220},[224],{"name":225,"role":83,"phone":226,"phoneExt":52,"email":227},"Xiao Shuai, M.D.","18980606797","5397781@qq.com",{"facility":229,"status":89,"city":230,"state":231,"zip":232,"country":93,"countryCode":94,"cosmosGeoPoint":233,"geoPoint":237,"contacts":238},"the First Affiliated Hospital, College of Medicine, Zhejiang University","Hangzhou","Zhejiang","310003",{"type":96,"coordinates":234},[235,236],120.16142,30.29365,{"lat":236,"lon":235},[239],{"name":78,"role":83,"phone":84,"phoneExt":52,"email":85},{"type":241,"investigatorFullName":52,"investigatorTitle":52,"investigatorAffiliation":52,"oldNameTitle":52,"oldOrganization":52},"SPONSOR",[243],{"name":75,"class":6},"100400967","phase-1-study-of-lisaftoclax-apg-2575-single-agent-and-combination-with-therapy-in-patients-relapsedrefractory-aml-100400967",false,"NCT04501120","Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed\u002FRefractory AML","A Phase Ib Study of the Safety, Pharmacokinetic of Lisaftoclax (APG-2575) Single Agent and in Combination With Homoharringtonine or Azacitidine in Patients With Relapsed\u002FRefractory AML","Inclusion Criteria:\n\nSubjects who meet each of the following inclusion criteria are eligible to participate in this study:\n\n1. In accordance with the World Health Organization (WHO) 2016 diagnostic criteria for relapsed or refractory acute myeloid leukemia (AML), Mixed phenotype acute leukemia(MPAL), Chronic myelomonocytic leukemia (CMML), Higher-risk myelodysplastic syndrome (HR-MDS) , Blastic plasmacytoid dendritic cell neoplasm (BPDCN) and naïve AML ineligible for treatment with a standard chemotherapy due to age or comorbidities.\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -2 (0 to 3 for participants \\>= 60 to 74 years of age who are evaluated as ineligible for treatment with standard chemotherapy).\n3. Subjects can accept oral administration of Lisaftoclax (APG-2575).\n4. Life expectancy ≥ 3 months.\n5. Adequate renal and liver function.\n6. Males, female patients of childbearing potential (postmenopausal women who must have been menopausal for at least 12 months to be considered infertile) and their partners voluntarily take contraception which the investigator considers effective during treatment and at least three months after the last dose of study drug.\n7. Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the patient prior to any study-specific procedures).\n8. Willingness and ability to comply with study procedures and follow-up examination.\n\nExclusion Criteria:\n\nPatients who meet any of the following exclusion criteria are not to be enrolled in this study:\n\n1. Patients diagnosed with acute promyelocytic leukemia or t(9;22)(q34.1;q11.2); BCR-ABL1 positive AML patients.\n2. The persistent toxicities caused by previous chemotherapy or radiotherapy has not been restored to lower than grade 2 by CTCAE 5.0 (except for alopecia).\n3. Known leukemia infiltration of the central nervous system.\n4. Symptomatic active fungal, bacterial and\u002For viral infections.\n5. Prior history of allogeneic hematopoietic stem cell transplantation or adoptive cell immunotherapy, autologous hematopoietic stem cell transplantation within 12 months.\n6. Within 14 days before the first dose of study drug, received chemotherapy (hydroxyurea is permitted more than 24 hours before the first dose of study drug), radiotherapy, surgery, immunotherapy, targeted therapy, biological therapy or any investigational treatment.\n7. Within 7 days before the first dose of study drug, received a strong and\u002For moderate CYP3A inducer and\u002For Inhibitor.\n8. At the discretion of the investigator, gastrointestinal diseases that affect the absorption of Lisaftoclax (APG-2575).\n9. Any other condition or circumstance, at the discretion of the investigator, that patients would be unsuitable for participation in the study.","ALL","18 Years",{"count":254,"type":255},682,"ESTIMATED","INTERVENTIONAL",[258,259],"PHASE1","PHASE2","The purpose of this study is to assess the safety, pharmacokinetic profile of Lisaftoclax (APG-2575) single agent and in combination with HHT\u002FAZA in patients with relapsed\u002Frefractory AML and related myeloid malignancies.",[262,263],"Relapsed\u002FRefractory Acute Myeloid Leukaemia","Myeloid Malignancy",[265,266,263,49],"Acute Myeloid Leukaemia (AML)","Bcl-2 Inhibitor","2026-04-27",{"date":269,"type":270},"2026-04-29","ACTUAL",{"date":272,"type":270},"2020-09-28",{"date":274,"type":255},"2029-09",{"name":5,"class":6},12]