[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648076":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":46,"locations":52,"responsibleParty":67,"collaborators":29,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":29,"enrollmentInfo":81,"targetDuration":29,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":29,"overallStatus":90,"whyStopped":29,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Polatuzumab vedotin in combination with ZR2 or Pola-ZR-Glo regimen","EXPERIMENTAL","Participants will receive zanubrutinib 160 mg BID orally (PO) on Days 1-21, lenalidomide 25 mg\u002Fday PO on Days 2-11, and rituximab 375 mg\u002Fm² intravenously (IV) on Day 1 of the first cycle. For the remaining five cycles, participants will receive either Pola-ZR2 or Pola-ZR-Glo. In the Pola-ZR2 regimen, participants will receive ZR2 in combination with polatuzumab vedotin 1.8 mg\u002Fkg IV on Cycle 2 Day 2 and on Day 1 of Cycles 3-6. In the Pola-ZR-Glo regimen, participants will receive zanubrutinib 160 mg BID PO on Days 1-21 of Cycles 1-6, lenalidomide 25 mg\u002Fday orally on Days 2-11 of Cycles 1-6, polatuzumab vedotin 1.8 mg\u002Fkg intravenously on Cycle 2 Day 2 and on Day 1 of Cycles 3-6, and glofitamab intravenously with step-up dosing of 2.5 mg on Cycle 2 Day 8, 10 mg on Cycle 2 Day 15, and 30 mg on Day 1 of Cycles 3-12. For participants receiving the ZR2 or Pola-ZR2 regimen, lenalidomide maintenance will be continued for 18 weeks after six cycles of treatment. Each treatment cycle is 21 days.",[13,14,15,16,17],"Drug: Polatuzumab Vedotin","Drug: Rituximab (R)","Drug: Zanubrutinib","Drug: Lenalidomide","Drug: Glofitamab",{"label":19,"type":20,"description":21,"interventionNames":22},"ZR2","ACTIVE_COMPARATOR","Participants will receive zanubrutinib 160 mg BID orally (PO) on Days 1-21, lenalidomide 25 mg\u002Fday orally on Days 2-11, and rituximab 375 mg\u002Fm² intravenously (IV) on Day 1 of every 21-day cycle for 6 cycles.",[14,15,16],[24,30,34,38,42],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Polatuzumab Vedotin","Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.",[9],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Rituximab (R)","Rituximab IV infusion will be administered as per the schedule specified in the respective arm.",[9,19],{"type":25,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"Zanubrutinib","Zanubrutinib PO will be administered as per the schedule specified in the respective arm.",[9,19],{"type":25,"name":39,"description":40,"armGroupLabels":41,"otherNames":29},"Lenalidomide","Lenalidomide PO will be administered as per the schedule specified in the respective arm.",[9,19],{"type":25,"name":43,"description":44,"armGroupLabels":45,"otherNames":29},"Glofitamab","Glofitamab IV infusion will be administered as per the schedule specified in the respective arm.",[9],[47],{"name":48,"role":49,"phone":50,"phoneExt":29,"email":51},"Weili Zhao","CONTACT","+862164370045 Ext. 610707","zwl_trial@163.com",[53],{"facility":5,"status":29,"city":54,"state":29,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Shanghai","200020","China","CN",{"type":59,"coordinates":60},"Point",[61,62],121.45806,31.22222,{"lat":62,"lon":61},[65],{"name":48,"role":49,"phone":66,"phoneExt":29,"email":51},"64370045",{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Zhao Weili","Professor and Director, Shanghai Institute of Hematology","100648076","phase-2-ai-driven-treatment-strategy-vs-zr2-in-older-treatment-naive-patients-with-lbcl-100648076",false,"NCT07717177","AI-Driven Treatment Strategy vs ZR2 in Older Treatment-naive Patients With LBCL","A Study to Evaluate the Efficacy and Safety of an AI-Driven Treatment Strategy Versus ZR2 in Older Treatment-naive Patients With Large B-cell Lymphoma (LBCL)","PRAISE","Inclusion Criteria:\n\nPatients must satisfy all of the following criteria to be enrolled in the study:\n\n* Histologically-confirmed large B-cell lymphoma (without central nervous system involvement)\n* Aged ≥ 70 years old with comprehensive geriatric assessment stratified as unfit or frail, or those who decline immunochemotherapy.\n* After 1 cycle of ZR2, classified as intermediate-risk or high-risk by AI-based multimodal stratification\n* Eastern Cooperative Oncology Group Performance Status 0-2\n* At least 1 measurable site of disease (defined as lymph nodes with the long diameters longer than 1.5cm, or extra-nodal sites with the long diameters longer than 1.0cm; meanwhile, any lesion site with at least 2 measurable vertical diameters)\n* Life expectancy of at least 3 months determined by researchers\n* The patient or his or her legal representative must provide written informed consent prior to any special examination or procedure for the research.\n* Anti-lymphoma drugs have not been used before (except glucocorticoids)\n\nExclusion Criteria:\n\nPresence of any of the following criteria will exclude a patient from enrollment:\n\n* Uncontrolled blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases\n* Laboratory measures meet the following criteria at screening (unless caused by lymphoma):\n\nNeutrophils\\\u003C1.0×10\\^9\u002FL Platelets\\\u003C75×10\\^9\u002FL ALT or AST is 2.5 times higher than the upper limits of normal (ULN), serum bilirubin are 1.5 times higher than the ULN.\n\neGFR is lower than 30ml\u002Fmin\u002F1.73m\\^2 (according to Cockcroft-Gault Equation or MDRD Equation).\n\n* uncontrollable or significant cardiovascular diseases, including but not limited to: Left ventricular ejection fraction\\\u003C50% Cardiomyopathy, such as dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy QTc prolongation with clinical significance, QTc interval\\>470ms (females) or 480ms (males), type 2 second-degree atrioventricular block or third-degree atrioventricular block\n* Patients with HbsAg positive are required to have HBV DNA\\\u003C1.0×10\\^3 IU\u002Fml before entering the group. In addition, if the patient is HBsAg negative but HBcAb positive (regardless of HBsAb status), HBV DNA test is also required, and HBV DNA\\\u003C1.0×10\\^3 IU\u002Fml is required before entering the group\n* Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol\n* HIV-infected patients\n* History of stroke or intracranial hemorrhage within 6 months prior to start of therapy\n* Other medical conditions determined by the researchers that may affect the study","ALL","70 Years",{"count":82,"type":83},112,"ESTIMATED","INTERVENTIONAL",[86],"PHASE2","This is a prospective, open-label, multicenter, randomized controlled study in older treatment-naive patients with LBCL. Participants will be stratified into different risk groups using an AI-based multimodal model. Those classified as intermediate- or high-risk will be randomized in a 1:1 ratio to receive either an AI-guided treatment strategy or ZR2. In the experimental arm, participants will receive polatuzumab vedotin in combination with ZR2 or Pola-ZR-Glo regimen (polatuzumab vedotin, zanubrutinib, lenalidomide, and glofitamab), according to their AI-defined risk group. Participants in the control arm will receive ZR2. The study will evaluate the efficacy and safety of the AI-guided treatment strategy compared with ZR2.",[89],"Large B-Cell Lymphoma (LBCL)","NOT_YET_RECRUITING","2026-07-18",{"date":93,"type":94},"2026-07-21","ACTUAL",{"date":96,"type":83},"2026-06-30",{"date":98,"type":83},"2029-12-31",{"name":5,"class":6},1]