[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641023":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":33,"centralContacts":66,"locations":75,"responsibleParty":92,"collaborators":33,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":98,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":33,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":33,"overallStatus":116,"whyStopped":33,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Genotype-guided targeted agents or glofitamab in combination with Pola-R-CHP","EXPERIMENTAL","Participants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg\u002Fkg) intravenously (IV) on Day 2, rituximab 375 milligrams per square meter (mg\u002Fm²) IV on Day 1, cyclophosphamide 750 mg\u002Fm² IV on Day 2, doxorubicin 50 mg\u002Fm² IV on Day 2, and prednisone 100 milligrams per day (mg\u002Fday) orally (PO) on Days 2-6 of the first 21-day cycle. For the remaining five cycles, participants will receive standard Pola-R-CHP in combination with one of the following: zanubrutinib 160 mg BID PO on Days 1-21, lenalidomide 25 mg\u002Fday PO on Days 2-11, decitabine 10 mg\u002Fm²\u002Fday IV on Days -5 to -1, or glofitamab administered IV 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 8 of Cycles 3-6. Each treatment cycle is 21 days.",[13,14,15,16,17,18,19,20,21],"Drug: Polatuzumab Vedotin","Drug: rituximab","Drug: Cyclophosphamide","Drug: Doxorubicin","Drug: Prednisone","Drug: Zanubrutinib","Drug: Lenalidomide","Drug: Decitabine","Drug: Glofitamab",{"label":23,"type":24,"description":25,"interventionNames":26},"Pola-R-CHP","ACTIVE_COMPARATOR","Participants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg\u002Fkg) intravenously (IV) on Day2, rituximab 375 milligrams per square meter (mg\u002Fm²) IV on Day 1, cyclophosphamide 750 mg\u002Fm² IV on Day 2, doxorubicin 50 mg\u002Fm² IV on Day 2, and prednisone 100 milligrams per day (mg\u002Fday) orally (PO) on Days 2-6 of every 21-day cycle for 6 cycles.",[13,14,15,16,17],[28,34,38,42,46,50,54,58,62],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Polatuzumab Vedotin","Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.",[9,23],null,{"type":29,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"rituximab","Rituximab IV infusion will be administered as per the schedule specified in the respective arm.",[9,23],{"type":29,"name":39,"description":40,"armGroupLabels":41,"otherNames":33},"Cyclophosphamide","Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.",[9,23],{"type":29,"name":43,"description":44,"armGroupLabels":45,"otherNames":33},"Doxorubicin","Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.",[9,23],{"type":29,"name":47,"description":48,"armGroupLabels":49,"otherNames":33},"Prednisone","Prednisone PO will be administered as per the schedule specified in the respective arm.",[9,23],{"type":29,"name":51,"description":52,"armGroupLabels":53,"otherNames":33},"Zanubrutinib","Zanubrutinib PO will be administered as per the schedule specified in the respective arm.",[9],{"type":29,"name":55,"description":56,"armGroupLabels":57,"otherNames":33},"Lenalidomide","Lenalidomide PO will be administered as per the schedule specified in the respective arm.",[9],{"type":29,"name":59,"description":60,"armGroupLabels":61,"otherNames":33},"Decitabine","Decitabine IV infusion will be administered as per the schedule specified in the respective arm.",[9],{"type":29,"name":63,"description":64,"armGroupLabels":65,"otherNames":33},"Glofitamab","Glofitamab IV infusion will be administered as per the schedule specified in the respective arm.",[9],[67,72],{"name":68,"role":69,"phone":70,"phoneExt":33,"email":71},"Weili Zhao","CONTACT","+862164370045 Ext. 610707","zwl_trial@163.com",{"name":73,"role":69,"phone":70,"phoneExt":33,"email":74},"Pengpeng Xu","pengpeng_xu@126.com",[76],{"facility":77,"status":33,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Ruijin Hospital, Shanghai Jiao Tong University School of Medicine","Shanghai","Shanghai Municipality","200020","China","CN",{"type":84,"coordinates":85},"Point",[86,87],121.45806,31.22222,{"lat":87,"lon":86},[90],{"name":68,"role":69,"phone":91,"phoneExt":33,"email":71},"64370045",{"type":93,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Zhao Weili","Professor and Director, Shanghai Institute of Hematology","100641023","phase-2-ai-driven-treatment-strategy-vs-pola-r-chp-in-untreated-lbcl-100641023",false,"NCT07594899","AI-Driven Treatment Strategy vs Pola-R-CHP in Untreated LBCL","A Study to Evaluate the Efficacy and Safety of an AI-Driven Treatment Strategy Versus Pola-R-CHP in Patients With Previously Untreated Large B-Cell Lymphoma","GUIDANCE-10","Inclusion Criteria:\n\n* Age 18-75 years with comprehensive geriatric assessment stratified as fit\n* Previously untreated participants with CD20-positive LBCL (without central nervous system involvement)\n* ECOG Performance Status of 0, 1, or 2\n* After 1 cycle of Pola-R-CHP, classified as intermediate-risk or high-risk by AI-based multimodal stratification\n* Life expectancy ≥ 3 months\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* 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\n* Prior solid organ transplantation or SCT\n* Significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 6 months prior to the start of Cycle 1, unstable arrhythmias, or unstable angina\n* History or presence of an abnormal ECG that is clinically significant in the investigator's opinion\n* Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma):\n\n  * Absolute neutrophil count \\\u003C1.0 × 10⁹\u002FL.\n  * Platelet count \\\u003C75 × 10⁹\u002FL\n  * Serum AST and ALT ≥ 2.5 x ULN\n  * Total bilirubin ≥ 1.5 x ULN\n  * Serum creatinine clearance \\\u003C 30 mL\u002Fmin (using Cockcroft-Gault formula)\n* Any active infection within 7 days prior to Cycle 1 Day 1 that would impact participant safety\n* Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \\[HBsAg\\] serology)：Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HbsAg) may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening. Such participants must be willing to undergo HBV DNA testing every month and appropriate antiviral therapy as indicated\n* Positive test results for hepatitis C (hepatitis C virus \\[HCV\\] antibody serology testing)：Participants positive for HCV antibody are eligible only if PCR is negative for HCV RNA\n* Participants with a history of progressive multifocal leukoencephalopathy\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 12 months after final dose of treatment\n* Participants with uncontrolled coagulation disorders, connective tissue diseases, severe infectious diseases\n* Other concurrent and uncontrolled medical conditions that, in the opinion of the investigator, would affect the patient's participation in the study","ALL","18 Years","75 Years",{"count":108,"type":109},178,"ESTIMATED","INTERVENTIONAL",[112],"PHASE2","This is a prospective, open-label, multicenter, randomized controlled study in participants with previously untreated large B-cell lymphoma. 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 Pola-R-CHP. In the experimental arm, participants will receive either genotype-guided targeted agents in combination with Pola-R-CHP or Pola-R-CHP combined with glofitamab, according to their AI-defined risk group and molecular features. Participants in the control arm will receive Pola-R-CHP. The study will evaluate the efficacy and safety of the AI-guided treatment strategy compared with Pola-R-CHP.",[115],"Large B-Cell Lymphoma (LBCL)","NOT_YET_RECRUITING","2026-05-17",{"date":119,"type":120},"2026-05-19","ACTUAL",{"date":122,"type":109},"2026-05-06",{"date":124,"type":109},"2029-12-31",{"name":5,"class":6},1]