[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620290":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":27,"locations":37,"responsibleParty":71,"collaborators":31,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":31,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":31,"enrollmentInfo":83,"targetDuration":31,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":39,"whyStopped":31,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Beijing Tongren Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Orelabrutinib-based treatments","EXPERIMENTAL","This is a single-arm study without a control group. All subjects will receive orelabrutinib treatment but will be stratified based on disease stage and clinical characteristics into the following two groups:\n\n1. Stage I MZL Patient Group (Monotherapy Group) Treatment regimen: Orelabrutinib monotherapy. Dosage and administration: Orelabrutinib 150mg, once daily (qd), taken continuously for 21 days per treatment cycle (d1-d21), for a total of 6 cycles (C1-C6).\n2. Stage II-IV MZL Patient Group (Combination Therapy Group) Treatment regimen: Orelabrutinib combined with a CD20 monoclonal antibody. Dosage and administration: Orelabrutinib 150mg, once daily (qd), taken continuously for 21 days per treatment cycle (d1-d21), for a total of 6 cycles (C1-C6). CD20 monoclonal antibody (either Rituximab 375mg\u002Fm², intravenous infusion, Day 1 of each cycle, C1-C6; or Obinutuzumab 1000mg, intravenous infusion, on Days 1, 8, and 15 of Cycle 1 \\[C1\\], and on Day 1 of Cycles 2-6 \\[C2-C6\\].",[13],"Drug: Orelabrutinib",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Orelabrutinib","1. Stage I MZL Patients:\n\n   Treatment with Orelabrutinib monotherapy. Induction Phase: During Cycles 1-6 (C1-C6), Orelabrutinib 150mg is administered orally once daily (qd) on Days 1-21 (d1-d21) of each cycle.\n2. Stage II-IV MZL Patients:\n\nTreatment with the Orelabrutinib plus CD20 monoclonal antibody regimen, divided into an induction phase and a maintenance phase.\n\nInduction Phase: During Cycles 1-6 (C1-C6), Orelabrutinib 150mg is administered orally once daily (150mg qd d1-d21\u002FC1-C6). Concurrently, a CD20 monoclonal antibody is used: either Rituximab 375mg\u002Fm² intravenously (iv) on Day 1 of each cycle (d1\u002FC1-C6); or Obinutuzumab, administered as 1000mg intravenously on Days 1, 8, and 15 of Cycle 1 (1000mg iv d1,d8,d15\u002FC1), followed by 1000mg intravenously on Day 1 of Cycles 2-6 (1000mg iv d1\u002FC2-C6).\n\nMaintenance Phase: If maintenance therapy is administered, during Cycles 7-30 (C7-C30), Orelabrutinib 150mg is administered orally once daily (qd) on Days 1-28 (d1-d28) of each cycle.",[9],[21,22],"Rituximab","Obinutuzumab",[24],{"name":25,"affiliation":5,"role":26},"Liang Wang, MD","PRINCIPAL_INVESTIGATOR",[28,33],{"name":25,"role":29,"phone":30,"phoneExt":31,"email":32},"CONTACT","+86 15013009093",null,"wangliangtrhos@126.com",{"name":34,"role":29,"phone":35,"phoneExt":31,"email":36},"Wei Zhang, MD","+86 13681473557","vv1223@vip.sina.com",[38,52,61],{"facility":5,"status":39,"city":40,"state":31,"zip":31,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Beijing","China","CN",{"type":44,"coordinates":45},"Point",[46,47],116.39723,39.9075,{"lat":47,"lon":46},[50],{"name":51,"role":29,"phone":30,"phoneExt":31,"email":32},"Liang Wang, PhD",{"facility":53,"status":54,"city":40,"state":31,"zip":31,"country":41,"countryCode":42,"cosmosGeoPoint":55,"geoPoint":57,"contacts":58},"Peking Union Medical College Hospital","NOT_YET_RECRUITING",{"type":44,"coordinates":56},[46,47],{"lat":47,"lon":46},[59],{"name":60,"role":29,"phone":35,"phoneExt":31,"email":36},"Wei Zhang, PhD",{"facility":62,"status":54,"city":40,"state":31,"zip":31,"country":41,"countryCode":42,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"The First Affiliated Hospital of China Medical University",{"type":44,"coordinates":64},[46,47],{"lat":47,"lon":46},[67],{"name":68,"role":29,"phone":69,"phoneExt":31,"email":70},"Xiaojing Yan, PhD","+86 13889128302","yanxiaojingpp@hotmail.com",{"type":26,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"LIANG WANG","Chief Physician of Hematology Department","100620290","phase-4-application-of-orelabrutinib-with-or-without-cd20-monoclonal-antibody-in-previously-untreated-marginal-zone-lymphoma-100620290",false,"NCT07355699","Application of Orelabrutinib With or Without CD20 Monoclonal Antibody in Previously Untreated Marginal Zone Lymphoma","Application of Orelabrutinib With or Without CD20 Monoclonal Antibody in Previously Untreated Marginal Zone Lymphoma:A Phase II, Prospective, Multicenter, Single-Arm Clinical Study","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Pathologically confirmed marginal zone lymphoma;\n* Presence of evaluable lesions;\n* Meets indications for treatment: Fulfills the GELF criteria OR has disease-related clinical symptoms\u002Forgan function impairment;\n* Patients who are unsuitable for local radiotherapy, refuse local radiotherapy, or have disease progression after local therapy. Cases considered unsuitable for local radiotherapy include the following:\n\nGastric MALT MZL, Ann Arbor stage I, that is H. pylori-negative, or H. pylori-positive gastric MALT MZL (Ann Arbor stage I) with poor response to H. pylori eradication therapy;\n\nNon-gastric MALT and nodal MZL in Ann Arbor non-contiguous stage II or stages III-IV;\n\nSMZL;\n\nGastric MALT classified as Lugano II2, IIE, or IV stage;\n\nPatient intolerance to radiotherapy;\n\nOther MZL patients deemed unsuitable for local radiotherapy by the investigator.\n\n* ECOG score of 0-3;\n* Expected survival time ≥ 3 months;\n* Ability to provide signed informed consent.\n\nExclusion Criteria:\n\n* Currently diagnosed with another malignant tumor;\n* Central nervous system involvement by lymphoma or transformation to a higher grade;\n* Allergy to any of the investigational drugs;\n* Active infection or uncontrolled HBV infection, HIV\u002FAIDS, or other serious infectious diseases;\n* Pregnancy, lactating women, or subjects of childbearing potential unwilling to use contraception;\n* Other situations deemed by the investigator as unsuitable for participation in this trial.","ALL","18 Years",{"count":84,"type":85},88,"ESTIMATED","INTERVENTIONAL",[88],"PHASE4","This study focuses on treatment-naïve marginal zone lymphoma (MZL) patients and aims to investigate the efficacy and safety of orelabrutinib combined with or without CD20 monoclonal antibody.\n\nThis is a single-arm study without a control group. All subjects will receive orelabrutinib treatment but will be stratified based on disease stage and clinical characteristics into the following two groups:\n\n1. Stage I MZL Patient Group (Monotherapy Group) Treatment regimen: Orelabrutinib monotherapy. Dosage and administration: Orelabrutinib 150mg, once daily (qd), taken continuously for 21 days per treatment cycle (d1-d21), for a total of 6 cycles (C1-C6).\n\n   Target population: Patients with Ann Arbor Stage I gastric MALT MZL, including H. pylori-negative patients or those with unsatisfactory response after anti-H. pylori therapy, as well as other Stage I MZL patients unsuitable for local radiotherapy.\n\n   Sample size: 50 cases.\n2. Stage II-IV MZL Patient Group (Combination Therapy Group) Treatment regimen: Orelabrutinib combined with a CD20 monoclonal antibody. Dosage and administration: Orelabrutinib 150mg, once daily (qd), taken continuously for 21 days per treatment cycle (d1-d21), for a total of 6 cycles (C1-C6). CD20 monoclonal antibody (either Rituximab 375mg\u002Fm², intravenous infusion, Day 1 of each cycle, C1-C6; or Obinutuzumab 1000mg, intravenous infusion, on Days 1, 8, and 15 of Cycle 1 \\[C1\\], and on Day 1 of Cycles 2-6 \\[C2-C6\\]).\n\nTarget population: Patients with Ann Arbor Stage II-IV non-gastric MALT MZL, nodal MZL, splenic marginal zone lymphoma (SMZL), and other Stage II-IV MZL patients unsuitable for local radiotherapy.\n\nSample size: 38 cases.",[91],"Marginal Zone Lymphoma(MZL)",[93,17,94],"Marginal Zone Lymphoma","CD20 Monoclonal Antibody","2026-01-13",{"date":97,"type":98},"2026-01-21","ACTUAL",{"date":100,"type":98},"2025-11-25",{"date":102,"type":85},"2028-12-31",{"name":5,"class":6},3]