[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100400459":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":39,"centralContacts":44,"locations":50,"responsibleParty":261,"collaborators":30,"id":263,"slug":264,"hasResults":265,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":30,"eligibilityCriteria":269,"healthyVolunteers":265,"sex":270,"minAge":271,"maxAge":30,"enrollmentInfo":272,"targetDuration":30,"studyType":275,"phases":276,"briefSummary":279,"conditions":280,"keywords":283,"overallStatus":53,"whyStopped":30,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":297},{"fullName":5,"class":6},"Ascentage Pharma Group Inc.","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"APG-2575 single agent in Relapse\u002FRefractory CLL\u002FSLL","EXPERIMENTAL","APG-2575 orally once daily at 400mg, 600mg, 800mg dose levels respectively, every 28 days as a cycle.",[13],"Drug: APG-2575",{"label":15,"type":10,"description":16,"interventionNames":17},"APG-2575+Rituximab in Relapse\u002FRefractory CLL\u002FSLL","Stage 1:APG-2575 orally once daily starting from 200mg and will be increased in subsequent cohorts to 400mg, 600mg, 800mg. Rituximab 375mg\u002Fm2 ivgtt on C1D8 and 500mg\u002Fm2 ivgtt on C2-6D1. Every 28 days as a cycle.\n\nStage 2: APG-2575 MTD\u002FRP2D combined with rituximab. Every 28 days as a cycle.",[13,18],"Drug: Rituximab",{"label":20,"type":10,"description":21,"interventionNames":22},"APG-2575+ibrutinib in Relapse\u002FRefractory CLL\u002FSLL","Stage 1: APG-2575 orally once daily starting from 200mg and will be increased in subsequent cohorts to 400mg, 600mg, 800mg.Ibrutinib 420mg orally once daily during C1D8-28 and following cycles. Every 28 days as a cycle.\n\nStage 2: APG-2575 MTD\u002FRP2D combined with ibrutinib. Every 28 days as a cycle.",[13,23],"Drug: Ibrutinib",[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","APG-2575","APG-2575 orally once daily, every 28 days as a cycle.",[9,15,20],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Rituximab","Rituximab 375mg\u002Fm2 ivgtt on C1D8 and 500mg\u002Fm2 ivgtt on C2-6D1.",[15],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Ibrutinib","Ibrutinib 420mg orally once daily during C1D8-28 and following cycles.",[20],[40],{"name":41,"affiliation":42,"role":43},"Yifan Zhai, M.D., Ph.D.","yzhai@ascentage.com","STUDY_DIRECTOR",[45],{"name":46,"role":47,"phone":48,"phoneExt":30,"email":49},"Jianyong Li, M.D.","CONTACT","+86-25-83781120","lijianyonglm@medmail.com.cn",[51,67,79,95,107,119,131,138,150,162,173,181,194,206,220,229,241,253],{"facility":52,"status":53,"city":54,"state":55,"zip":30,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Peking University Third Hospital","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":59,"coordinates":60},"Point",[61,62],116.39723,39.9075,{"lat":62,"lon":61},[65],{"name":66,"role":47,"phone":30,"phoneExt":30,"email":30},"Hongmei Jing, M.D.",{"facility":68,"status":53,"city":69,"state":70,"zip":30,"country":56,"countryCode":57,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Chongqing Cancer Hospital","Chongqing","Chongqing Municipality",{"type":59,"coordinates":72},[73,74],106.55771,29.56026,{"lat":74,"lon":73},[77],{"name":78,"role":47,"phone":30,"phoneExt":30,"email":30},"Yi Gong, M.D., Ph.D.",{"facility":80,"status":53,"city":81,"state":82,"zip":30,"country":56,"countryCode":57,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Nanfang Hospital of Southern Medical University","Guangzhou","Guangdong",{"type":59,"coordinates":84},[85,86],113.25,23.11667,{"lat":86,"lon":85},[89,93],{"name":90,"role":47,"phone":91,"phoneExt":30,"email":92},"Chongyuan Xu Professor","+86+020-62786845","nfyygcp@126.com",{"name":94,"role":47,"phone":30,"phoneExt":30,"email":30},"Ru Feng Professor",{"facility":96,"status":53,"city":97,"state":98,"zip":30,"country":56,"countryCode":57,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Guangxi Medical University Affiliated Tumor Hospital","Nanning","Guangxi",{"type":59,"coordinates":100},[101,102],108.31667,22.81667,{"lat":102,"lon":101},[105],{"name":106,"role":47,"phone":30,"phoneExt":30,"email":30},"Hong Cen, Doctor",{"facility":108,"status":53,"city":109,"state":110,"zip":30,"country":56,"countryCode":57,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"The Affiliated Hospital of Guizhou Medical University","Guiyang","Guizhou",{"type":59,"coordinates":112},[113,114],106.71667,26.58333,{"lat":114,"lon":113},[117],{"name":118,"role":47,"phone":30,"phoneExt":30,"email":30},"Jishi Wang, Doctor",{"facility":120,"status":53,"city":121,"state":122,"zip":30,"country":56,"countryCode":57,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"The Fourth Hospital of Hebei Medical University","Shijiazhuang","Hebei",{"type":59,"coordinates":124},[125,126],114.47861,38.04139,{"lat":126,"lon":125},[129],{"name":130,"role":47,"phone":30,"phoneExt":30,"email":30},"Lihong Liu, M.D.",{"facility":132,"status":53,"city":133,"state":134,"zip":30,"country":56,"countryCode":57,"cosmosGeoPoint":30,"geoPoint":30,"contacts":135},"Henan Provincial Oncology Hospital","Zhenzhou","Henan",[136],{"name":137,"role":47,"phone":30,"phoneExt":30,"email":30},"Keshu Zhou, Doctor",{"facility":139,"status":53,"city":140,"state":141,"zip":30,"country":56,"countryCode":57,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Union Hospital medical college Huazhong University of Science and Technology","Wuhan","Hubei",{"type":59,"coordinates":143},[144,145],114.26667,30.58333,{"lat":145,"lon":144},[148],{"name":149,"role":47,"phone":30,"phoneExt":30,"email":30},"Guohui Cui, M.D.",{"facility":151,"status":53,"city":152,"state":153,"zip":30,"country":56,"countryCode":57,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Xiangya Hospital Central South University","Changsha","Hunan",{"type":59,"coordinates":155},[156,157],112.97087,28.19874,{"lat":157,"lon":156},[160],{"name":161,"role":47,"phone":30,"phoneExt":30,"email":30},"Xielan Zhao, M.D.",{"facility":163,"status":53,"city":164,"state":165,"zip":30,"country":56,"countryCode":57,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"The First Affiliated Hospital of Nanjing Medical University","Nanjing","Jiangsu",{"type":59,"coordinates":167},[168,169],118.77778,32.06167,{"lat":169,"lon":168},[172],{"name":46,"role":47,"phone":30,"phoneExt":30,"email":49},{"facility":174,"status":53,"city":164,"state":165,"zip":30,"country":56,"countryCode":57,"cosmosGeoPoint":175,"geoPoint":177,"contacts":178},"Zhongda Hospital Southeast University",{"type":59,"coordinates":176},[168,169],{"lat":169,"lon":168},[179],{"name":180,"role":47,"phone":30,"phoneExt":30,"email":30},"Xiaoping Zhang, M.D.",{"facility":182,"status":53,"city":183,"state":165,"zip":30,"country":56,"countryCode":57,"cosmosGeoPoint":184,"geoPoint":188,"contacts":189},"The First affiliated hospital of Soochow University","Suzhou",{"type":59,"coordinates":185},[186,187],120.59538,31.30408,{"lat":187,"lon":186},[190],{"name":191,"role":47,"phone":192,"phoneExt":30,"email":193},"Caixia Li, M.D.","+86-0512-67781856","suzhouhematology@163.com",{"facility":195,"status":53,"city":196,"state":197,"zip":30,"country":56,"countryCode":57,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"The First affiliated hospital of Nanchang University","Nanchang","Jiangxi",{"type":59,"coordinates":199},[200,201],115.85306,28.68396,{"lat":201,"lon":200},[204],{"name":205,"role":47,"phone":30,"phoneExt":30,"email":30},"Li Professor",{"facility":207,"status":53,"city":208,"state":209,"zip":30,"country":56,"countryCode":57,"cosmosGeoPoint":210,"geoPoint":214,"contacts":215},"Fudan University Shanghai Cancer Center","Shanghai","Shanghai Municipality",{"type":59,"coordinates":211},[212,213],121.45806,31.22222,{"lat":213,"lon":212},[216,218],{"name":217,"role":47,"phone":30,"phoneExt":30,"email":30},"Fangfang LV, Master",{"name":219,"role":47,"phone":30,"phoneExt":30,"email":30},"Dongmei Ji, Doctor",{"facility":221,"status":222,"city":208,"state":209,"zip":30,"country":56,"countryCode":57,"cosmosGeoPoint":223,"geoPoint":225,"contacts":226},"Fudan University Zhongshan Hospital","NOT_YET_RECRUITING",{"type":59,"coordinates":224},[212,213],{"lat":213,"lon":212},[227],{"name":228,"role":47,"phone":30,"phoneExt":30,"email":30},"Peng Liu, M.D.",{"facility":230,"status":53,"city":231,"state":232,"zip":30,"country":56,"countryCode":57,"cosmosGeoPoint":233,"geoPoint":237,"contacts":238},"Blood Diseases Hospital Chinese Academy of Medical Sciences","Tianjin","Tianjin Municipality",{"type":59,"coordinates":234},[235,236],117.17667,39.14222,{"lat":236,"lon":235},[239],{"name":240,"role":47,"phone":30,"phoneExt":30,"email":30},"Shuhua Yi, Doctor",{"facility":242,"status":53,"city":243,"state":244,"zip":30,"country":56,"countryCode":57,"cosmosGeoPoint":245,"geoPoint":249,"contacts":250},"The First Bethune Hospital of Jilin University","Hangzhou","Zhejiang",{"type":59,"coordinates":246},[247,248],120.16142,30.29365,{"lat":248,"lon":247},[251],{"name":252,"role":47,"phone":30,"phoneExt":30,"email":30},"Jie Jin, Doctor",{"facility":254,"status":53,"city":243,"state":244,"zip":30,"country":56,"countryCode":57,"cosmosGeoPoint":255,"geoPoint":257,"contacts":258},"The Second Affiliated Hospital, Zhejiang University School of Medicine",{"type":59,"coordinates":256},[247,248],{"lat":248,"lon":247},[259],{"name":260,"role":47,"phone":30,"phoneExt":30,"email":30},"Wenbin Qian, Doctor",{"type":262,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100400459","phase-1-study-of-apg2575-single-agent-and-combination-therapy-in-patients-with-relapsedrefractory-cllsll-100400459",false,"NCT04494503","Study of APG2575 Single Agent and Combination Therapy in Patients With Relapsed\u002FRefractory CLL\u002FSLL","A Phase Ib\u002FII Study of the Safety, Pharmacokinetic, Pharmacodynamic and Efficacy of APG-2575 Single Agent and in Combination With Other Therapeutic Agents in Patients With Relapsed\u002FRefractory CLL\u002FSLL","Inclusion Criteria:\n\nSubjects who meet each of the following inclusion criteria are eligible to participate in this study:\n\n1. Age ≥18 years old.\n2. Diagnosis as relapsed\u002Frefractory chronic lymphocytic leukemia\u002F small lymphocytic lymphoma according to the IWCLL NCI-WG guidelines revised in 2008.\n3. Through radiological assessment, subjects with a lymph node length ≥ 10 cm require prior approval from the sponsor before enrollment.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -1.\n5. QTcF interval ≤450ms in males, and ≤470ms in females.\n6. Adequate bone marrow function independent of growth factor and transfusion.\n7. Adequate renal and liver function.\n8. Willingness by males, female patients of child bearing potential, and their partners to use contraception by effective methods throughout the treatment period and for at least three months following the last dose of study drug.\n9. Pregnancy test results of serum samples obtained within 14 days before the first study drug administration in fertile female subjects were negative; If the serum pregnancy test results obtained are\\> 7 days from the first administration, urine sample obtained before the first study dose of study drug must be negative.\n10. Male subjects must avoid sperm donation throughout the treatment period and for at least three months following the last dose of study drug.\n11. Ability to understand and willingness to sign a written informed consent form approved by EC committee (the consent form must be signed by the patient prior to any screening or study-specific procedures).\n12. 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. Prior history of allogeneic hematopoietic stem cell transplantation, adoptive cell immunotherapy within 24 months or autologous hematopoietic stem cell transplantation within 12 months.\n2. Monoclonal antibody therapy against CLL was adopted within 4 weeks prior to the first dose of the study drug.\n3. Receive any of the following treatments within 14 days or 5x half-life before the first dose of study drug, or clinically significant adverse reactions \u002F toxicities due to previous treatments have not recovered to ≤ Grade 1: Anti-tumor therapies include chemotherapy, radiotherapy, anti-tumor steroid treatment, anti-tumor Chinese medicine treatment; investigational treatment, including targeted small molecule drugs.\n4. Use the following drugs within 14 days before the first dose of study drug: moderately potent CYP3A inhibitors such as fluconazole, ketoconazole and clarithromycin; moderately potent CYP3A inducers such as rifampin, carbamazepine, phenytoin And St. John's wort.\n5. Failure to recover adequately, at the discretion of the investigator, from prior surgical procedures. Patients who have had major surgery within 28 days from study entry, and patients who have had minor surgery within 14 days of study entry.\n6. Received Bcl-2 inhibitor treatment.\n7. Invasive NHL transformation or central nervous system (CNS) involvement. has occurred.\n8. Cardiovascular disease of grade ≥2 (New York Heart Association Class).\n9. A significant history of renal, neurological, psychiatric, pulmonary, endocrine, metabolic, immune, cardiovascular or liver disease. The investigator believes that participating in this study will have an adverse effect on him \u002F her. For subjects requiring intervention for any of the above diseases in the past 6 months, the investigator and the sponsor must discuss.\n10. Warfarin or other anticoagulants is required.\n11. Known to be allergic to study drug ingredients or their analogues.\n12. Pregnancy or lactation, or pregnancy is expected during the study period or within 3 months after the last administration of treatment.\n13. Within 3 years before entering the study, the subject had a history of active malignant tumors other than CLL \u002F SLL, except that:\n\n    * Fully treated cervical carcinoma in situ;\n    * Completely resected basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;\n    * confinement and resection of previously cured malignancies (or other treatment).\n14. Has malabsorption syndrome or other conditions that are not suitable for enteral administration.\n15. Uncontrolled other clinically significant symptoms, including but not limited to: uncontrolled systemic infections (viruses, bacteria, or fungi), including but not limited to known hepatitis B virus (HBV) surface antigens and DNA positive(HBV-DNA≥2000copies\u002FmL or ≥500IU\u002FmL); Hepatitis C virus (HCV) antibody positive or RNA positive; human immunodeficiency virus (HIV) antibody positive; Febrile neutropenia occured within 1 week before administration.\n16. Primary active autoimmune diseases and connective tissue diseases, such as active and uncontrolled primary autoimmune hemocytopenia, including autoimmune hemolytic anemia (AIHA) and primary immune thrombocytopenia (ITP).\n17. Any other condition or circumstance that would, at the discretion of the investigator, make the patient unsuitable for participation in the study.","ALL","18 Years",{"count":273,"type":274},123,"ESTIMATED","INTERVENTIONAL",[277,278],"PHASE1","PHASE2","The purpose of this study is to assess the safety, pharmacokinetic, pharmacodynamic and efficacy of APG-2575 single agent and in combination with other therapeutic agents in patients with relapsed\u002Frefractory CLL\u002FSLL.",[281,282],"Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma",[27,284,285,286,287],"rituximab","ibrutinib","chronic lymphocytic leukemia(CLL)","small lymphocytic lymphoma(SLL)","2025-04-15",{"date":290,"type":291},"2025-04-16","ACTUAL",{"date":293,"type":291},"2020-08-31",{"date":295,"type":274},"2025-12",{"name":5,"class":6},18]