[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590929":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":36,"locations":42,"responsibleParty":59,"collaborators":23,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":23,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":44,"whyStopped":23,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ZRMTX","EXPERIMENTAL","Zanubrutinib\u002FRituximab\u002FIV MTX \\& intravitreal MTX Experimental arm will be treated with rituximab plus zanubrutinib (ZR) regimen for 4 cycles, ZR plus iv MTX for 2 cytles and followed by zanubrutinib maintenance for 2 years ( or choose to stop zanubrutinib maintenance if reached CR with negative CSF cfDNA). Meanwhile, intravitreal methotrexate will be given as protocol during the 1st year of treatment.",[13,14,15,16],"Drug: Methotrexate","Drug: Rituximab (R)","Drug: Zanubrutinib","Drug: Methotrexate (MTX)",[18,24,28,32],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Methotrexate","400ug intravitreal injection every week for 4 doses in the induction phase, every 2 weeks for 2 doses as consolidation, then every month for 10 doses",[9],null,{"type":19,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Rituximab (R)","Rituximab 375mg\u002Fm2 intravenous infusion d1, every 21 days for 1 cycle. 6 cycles will be prescribed as protocol",[9],{"type":19,"name":29,"description":30,"armGroupLabels":31,"otherNames":23},"Zanubrutinib","160mg Bid, oral. 21-day cycle for 6 cycles in the induction phase and for 2 years in the maintenance phase",[9],{"type":19,"name":33,"description":34,"armGroupLabels":35,"otherNames":23},"Methotrexate (MTX)","Methotrexate 3.5g\u002Fm2 intravenous infusion d1, every 21 days for cycle 5 and 6 only.",[9],[37],{"name":38,"role":39,"phone":40,"phoneExt":23,"email":41},"Wei Zhang, M.M.","CONTACT","13681473557","vv1223@vip.sina.com",[43],{"facility":5,"status":44,"city":45,"state":46,"zip":23,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":50,"coordinates":51},"Point",[52,53],116.39723,39.9075,{"lat":53,"lon":52},[56,57],{"name":38,"role":39,"phone":40,"phoneExt":23,"email":41},{"name":38,"role":58,"phone":23,"phoneExt":23,"email":23},"PRINCIPAL_INVESTIGATOR",{"type":58,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Wei Zhang","Prof.","100590929","phase-2-zr-mtx-for-piol-phase-ii-trial-100590929",false,"NCT06973811","ZR-MTX for PIOL Phase II Trial","A Prospective, Phase II Clinical Trial Using the Combination of Zanubrutinib, Rituximab and High-dose Intravenous Methotrexate With Intravitreal Methotrexate Injection Therapy for the Treatment of Primary Intraocular Lymphoma","ZR-MTX","Inclusion Criteria:\n\n* • Newly-diagnosed primary vitreoretinal lymphoma\n\n  * ECOG≤2\n  * creatinine clearance rate (CCR) ≥ 60ml\u002Fh, according to Cockcroft-Gault\n  * Total bilirubin # 2 upper limits of normal, alanine aminotransferase#ALT# \\\u003C 3 upper limits of normal\n  * Sign the Informed consent\n  * Women of childbearing potential must understand that the study medication could have a potential teratogenic risk. They should undergo complete contraception during the study period.\n  * Male subjects must agree to use condoms throughout study drug therapy.\n\nExclusion Criteria:\n\n* • primary central nervous system lymphoma involved eyes and brain\n\n  * systemic B cell lymphoma involved eyes\n  * Pre-existing uncontrolled active infection\n  * Clinical evidence of grade 3 or 4 heart failure as defined by the New York Heart Association criteria\n  * Pregnancy or active lactation\n  * Co-existing tumors\n  * HIV or HBV or HCV infection","ALL","18 Years","75 Years",{"count":74,"type":75},47,"ESTIMATED","INTERVENTIONAL",[78],"PHASE2","This is a prospective single-arm phase II study, with the purpose of evaluating the efficiency of ZR-MTX regimen (Rituximab, Zanubrutinib and methotrexate) combined with intravitreal methotrexate, then followed by minimal residual disease directed Zanubrutinib maintenance in newly-diagnosed primary intraocular lymphoma. The primary endpoint of this study is progression-free survival (PFS).",[81],"Primary Intraocular Lymphoma",[83],"primary intraocular lymphoma","2026-08-04",{"date":86,"type":87},"2026-08-07","ACTUAL",{"date":89,"type":87},"2025-05-21",{"date":91,"type":75},"2029-10-30",{"name":5,"class":6},1]