[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613892":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":39,"centralContacts":40,"locations":46,"responsibleParty":66,"collaborators":68,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":39,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":39,"enrollmentInfo":94,"targetDuration":39,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":49,"whyStopped":39,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Orelabrutinib + Lisaftoclax + Rituximab and Orelabrutinib + Lisaftoclax Maintenance","EXPERIMENTAL","1. In induction phase, patients will receive rituximab 375 mg\u002Fm² IV on day 1\u002Fcycle; orelabrutinib 150 mg\u002Fday PO once daily; and lisaftoclax PO Cycle1(100mg day1, 200mg day2, 400mg day3, 600mg\u002Fday day4-28), Cycle2-6 600mg\u002Fday, every 28 day per cycle for 6 cycles.\n2. In maintenance phase, Patients with an objective response (complete or partial) after induction therapy will recieve orelabrutinib 150 mg\u002Fday PO once daily and lisaftoclax 600mg\u002Fday PO once daily, every 28 day per cycle for 24 cycles.",[13,14,15],"Drug: Orelabrutinib","Drug: Rituximab (R)","Drug: Lisaftoclax (APG-2575)",[17,24,29,34],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Orelabrutinib","150mg\u002Fday PO once daily",[9],[23],"Induction phase",{"type":18,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"Rituximab (R)","375 mg\u002Fm² IV on day 1\u002Fcycle",[9],[23],{"type":18,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Lisaftoclax (APG-2575)","Cycle1(100mg day1, 200mg day2, 400mg day3, 600mg\u002Fday day4-28), Cycle2-6 600mg\u002Fday, PO once daily.",[9],[23],{"type":18,"name":30,"description":35,"armGroupLabels":36,"otherNames":37},"600mg\u002Fday, PO once daily",[9],[38],"Maintenance phase",null,[41],{"name":42,"role":43,"phone":44,"phoneExt":39,"email":45},"Li Wang","CONTACT","+862164370045","wl11194@rjh.com.cn",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine","RECRUITING","Shanghai","Shanghai Municipality","200025","China","CN",{"type":56,"coordinates":57},"Point",[58,59],121.45806,31.22222,{"lat":59,"lon":58},[62],{"name":63,"role":43,"phone":64,"phoneExt":39,"email":65},"Weili Zhao M.D. and Ph.D","13512112076","zhao.weili@yahoo.com",{"type":67,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[69,71,73,75,77,79,81,83],{"name":70,"class":6},"Fujian Medical University Union Hospital",{"name":72,"class":6},"First Affiliated Hospital of Wenzhou Medical University",{"name":74,"class":6},"The First Affiliated Hospital of Anhui Medical University",{"name":76,"class":6},"The Third Xiangya Hospital of Central South University",{"name":78,"class":6},"Qilu Hospital of Shandong University",{"name":80,"class":6},"Shanghai Minhang Central Hospital",{"name":82,"class":6},"Huadong Hospital",{"name":84,"class":6},"Yangpu District Central Hospital Affiliated to Tongji University","100613892","phase-2-orelabrutinib-plus-lisaftoclax-and-rituximab-in-untreated-mantle-cell-lymphoma-with-high-risk-disease-100613892",false,"NCT07272499","Orelabrutinib Plus Lisaftoclax and Rituximab in Untreated Mantle Cell Lymphoma With High-Risk Disease","A Prospective, Multicenter, Open-Label Clinical Study of Orelabrutinib Plus Lisaftoclax and Rituximab in Treatment-Naive, High-Risk Mantle Cell Lymphoma (MCL)","Inclusion Criteria:\n\n* Diagnosed with MCL (mantle cell lymphoma) through flow cytometry or histopathology, and has not received prior treatment.\n* Age \\> 14 years of age, both genders are eligible.\n* Ann Arbor stage II-IV; for stage II subjects, those who require systemic therapy based on the investigator's judgment are eligible.\n* At least one measurable lesion.\n* Any one of the following high-risk factors is present: MIPI score of 6-11, Ki67 \\> 30%, TP53 mutation\u002Floss or p53 protein expression \\>50%, blastic or pleomorphic variation.\n* Laboratory tests (blood routine, liver and kidney function) meet the following requirements: a) Blood routine: White blood cell count ≥3.0×10\\^9\u002FL, absolute neutrophil count ≥1.5×10\\^9\u002FL, hemoglobin ≥90g\u002FL, platelet count ≥75×10\\^9\u002FL. b) Liver function: Transaminases ≤2.5 times the upper limit of normal, bilirubin ≤1.5 times the upper limit of normal. c) Serum creatinine 44-133 mmol\u002FL.\n* The investigator judges that the subject's life expectancy is greater than 12 weeks from the time of screening.\n* Willing and able to participate in all required assessments and procedures of the study protocol.\n\nExclusion Criteria:\n\n* Patients who have previously received treatment with BTK inhibitors.\n* Patients with severe complications or serious infections.\n* Patients with uncontrolled cardiovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.\n* Patients with active infections requiring systemic treatment, including bacterial, fungal, and viral infections.\n* HIV-infected individuals.\n* Patients with mental disorders or those who are known or suspected to be unable to fully comply with the study protocol.\n* Patients whom the investigator judges to have other conditions that make them unsuitable for participation in this study.","ALL","14 Years",{"count":95,"type":96},25,"ESTIMATED","INTERVENTIONAL",[99],"PHASE2","This multicenter, open-label, trial aims to evaluate the efficacy and safety of orelabrutinib plus lisaftoclax and rituximab in patients with high-risk mantle cell lymphoma (MCL). The primary objective is to assess the optimal complete response (CR) rate during the induction phase, with secondary objectives including progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and safety. Exploratory analysis will investigate the correlation between tumor biomarkers and treatment efficacy.",[102],"Mantle Cell Lymphoma (MCL)",[104],"Order2","2025-11-26",{"date":107,"type":108},"2025-12-09","ACTUAL",{"date":110,"type":108},"2025-09-10",{"date":112,"type":96},"2028-09-10",{"name":5,"class":6},1]