[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640126":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":53,"collaborators":19,"id":55,"slug":19,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":19,"enrollmentInfo":63,"targetDuration":19,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":19,"overallStatus":37,"whyStopped":19,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pola+ZRCHP","EXPERIMENTAL","Previously untreated DLBCL patients harboring MCD\u002FBN2\u002FN1 subtypes were treated with Pola-ZRCHP (Polatuzumab Vedotin in Combination With Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone，6 cycles, 21-day cycles), with Rituximab administered for 8 cycles. The regimen consisted of Polatuzumab vedotin (1.8 mg\u002Fkg IV, D1), Zanubrutinib (160 mg PO BID), and standard CHP (C 750 mg\u002Fm², H 50 mg\u002Fm² IV D1; P 100 mg PO D1-5). Following induction, patients achieving ≥Stable Disease (SD) per PET-CT entered the maintenance phase with Zanubrutinib (160 mg PO BID) and Tislelizumab (200 mg IV Q3W, up to 1 year), continuing until progression or unacceptable toxicity. Non-responders (\\\u003CSD) discontinued.",[13],"Drug: POLA-R-CHP+Zanubrutinib",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"DRUG","POLA-R-CHP+Zanubrutinib",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Wei Xu, PHD","Hematological Department, Jiangsu Province Hospital","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Jinhua Liang, MD","CONTACT","15952032421","1151525490@qq.com",{"name":32,"role":28,"phone":19,"phoneExt":19,"email":33},"Wei Xu, PhD","xuwei10000@hotmail.com",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Jiangsu Province Hospital","RECRUITING","Nanjing","Jiangsu","210000","China","CN",{"type":44,"coordinates":45},"Point",[46,47],118.77778,32.06167,{"lat":47,"lon":46},[50,51],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},{"name":52,"role":28,"phone":19,"phoneExt":19,"email":33},"Wei Xu",{"type":54,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100640126",false,"NCT07608978","Efficacy and Safety of Polatuzumab Vedotin in Combination With Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma of the MCD\u002FBN2\u002FN1 Subtypes","Pola-ZRCHP","Inclusion Criteria:\n\n* Age ≥18 years at the time of signing informed consent. Histologically confirmed Diffuse Large B-Cell Lymphoma (DLBCL) with MCD\u002FBN2\u002FN1 molecular subtypes defined by LymphGen classification.\n\nPreviously untreated (treatment-naïve). International Prognostic Index (IPI) score of 2-5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Life expectancy ≥6 months. At least one measurable lesion in two dimensions, defined as a maximum diameter \\>1.5 cm by CT or MRI.\n\nLeft Ventricular Ejection Fraction (LVEF) ≥50% as assessed by echocardiogram (ECHO).\n\nAdequate hematologic function (unless due to underlying disease, e.g., extensive bone marrow involvement, or splenomegaly secondary to splenic involvement deemed by the investigator to be caused by DLBCL; blood product transfusions are allowed), defined as follows:\n\nHemoglobin ≥9.0 g\u002FdL within 7 days prior to first treatment, without packed RBC transfusion.\n\nAbsolute Neutrophil Count (ANC) ≥1.0 × 10⁹\u002FL. Platelet count ≥75 × 10⁹\u002FL. Female participants of childbearing potential: Must agree to abstain from heterosexual intercourse or use contraception, and agree not to donate ova.\n\nMale participants: Must agree to abstain from heterosexual intercourse or use contraception, and agree not to donate sperm.\n\nExclusion Criteria:\n\nContraindication to any component of the Pola-ZRCHP regimen. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding onychomycosis) at screening, or any major infection occurring within 4 weeks prior to the first dose of study treatment (as judged by the investigator).\n\nSuspected or latent tuberculosis (confirmed by positive IFNγ release assay). Currently pregnant or breastfeeding, or planning a pregnancy during the study period or within 12 months after the last dose.\n\nHistory of confirmed Progressive Multifocal Leukoencephalopathy (PML). Current or history of Central Nervous System (CNS) lymphoma. Evidence of significant, uncontrolled concomitant disease that may affect compliance with the protocol or interpretation of results.\n\nSevere or extensive cardiovascular disease, such as New York Heart Association (NYHA) Class III or IV, or objective assessment of Class C or D cardiac disease; myocardial infarction within the past 6 months; unstable arrhythmias; or unstable angina.\n\nClinically significant liver disease, including active viral hepatitis or other hepatitis, current alcohol abuse, or cirrhosis.\n\nAny of the following abnormal laboratory values (unless these abnormalities are solely attributable to underlying lymphoma):\n\nINR or PT \\>1.5 × Upper Limit of Normal (ULN) in the absence of therapeutic anticoagulation.\n\nPTT or aPTT \\>1.5 × ULN in the absence of lupus anticoagulant. Serum AST and ALT ≥2.5 × ULN. Total bilirubin ≥1.5 × ULN. Estimated creatinine clearance \\\u003C40 mL\u002Fmin (using the Cockcroft-Gault formula). Positive HBV DNA test result. Positive Hepatitis C test result (Hepatitis C virus \\[HCV\\] antibody serology). Note:Patients with positive HCV antibody are eligible only if the PCR test for HCV RNA is negative.\n\nAny other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that gives reasonable suspicion of a disease or condition that contraindicates the use of the investigational drug(s).","ALL","18 Years",{"count":64,"type":65},35,"ESTIMATED","INTERVENTIONAL",[68],"PHASE2","This is a prospective, open-label, single-arm, single-center, Phase II clinical study designed to evaluate the efficacy and safety of Efficacy and Safety of Polatuzumab Vedotin in Combination With Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma of the MCD\u002FBN2\u002FN1 Subtypes.\n\nAfter successful screening, enrolled patients will receive 6 treatment cycles (21 days per cycle). Disease response will be assessed by CT\u002FPET-CT during treatment and after completion of induction. Patients who achieve CR\u002FPR\u002FSD will proceed to the maintenance phase; patients who do not achieve at least SD (i.e., fail to reach CR\u002FPR\u002FSD) during induction will discontinue the study. Patients with CR\u002FPR\u002FSD after induction will receive maintenance therapy with zanubrutinib plus tislelizumab until disease progression, unacceptable toxicity, or completion of 1 year of maintenance.\n\nEfficacy and safety assessments will be performed per protocol. Tumor response will be assessed by site investigators according to the 2014 Lugano criteria, including determination of response status, date of response, and date of progression\u002Frelapse.",[71],"Diffuse Large B-Cell Lymphoma (DLBCL)","2026-05-20",{"date":74,"type":75},"2026-05-27","ACTUAL",{"date":77,"type":65},"2026-06-01",{"date":79,"type":65},"2029-12-31",{"name":5,"class":6},1]