[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650180":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":26,"responsibleParty":41,"collaborators":20,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":20,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":20,"studyType":58,"phases":59,"briefSummary":11,"conditions":61,"keywords":20,"overallStatus":64,"whyStopped":20,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Changzhou No.2 People's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pirtobrutinib+Pola-R-CHP for newly diagnosed non GCB DLBCL","EXPERIMENTAL","This is a single-arm, open-label, multicenter clinical study evaluating the efficacy and safety of pirtobrutinib combined with Pola-R-CHP in previously untreated Non-GCB DLBCL. PET\u002FCT assessment will be performed after 3 cycles of combination therapy. Patients achieving CR\u002FPR will continue treatment for another 3 cycles, while those with PD\u002FSD will be discontinued from the study. Patients achieving CR\u002FPR after 6 cycles of treatment will undergo follow-up with PET\u002FCT or contrast-enhanced CT every 3 months during the first year and every 6 months thereafter, until disease progression, death, withdrawal of informed consent, or study completion, whichever occurs first.",[13],"Drug: Pirtobrutinib+Pola-R-CHP",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Pirtobrutinib+Pola-R-CHP","Pirtobrutinib 200 mg once daily Polatuzumab vedotin 1.8 mg\u002Fkg intravenously on Day 1 Rituximab 375 mg\u002Fm² on Day 1 Cyclophosphamide 750 mg\u002Fm² on Day 1 Doxorubicin 50 mg\u002Fm² on Day 1 Prednisone 100 mg on Days 1 to 5 Each cycle lasts 21 days. PET\u002FCT evaluation is conducted after 3 treatment cycles. Subjects who attain CR or PR will receive an additional 3 cycles of therapy. Subjects with PD or SD will be withdrawn from the study. Subjects who do not achieve CR or PR upon completion of 6 cycles will be withdrawn from the study.",[9],null,[22],{"name":23,"role":24,"phone":20,"phoneExt":20,"email":25},"Jianyong Li, PhD","CONTACT","lijianyonglm@126.com",[27],{"facility":28,"status":20,"city":29,"state":30,"zip":20,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Jiangsu Province Hospital The First Affiliated Hospital with Nanjing Medical University","Nanjing","Jiangsu","China","CN",{"type":34,"coordinates":35},"Point",[36,37],118.77778,32.06167,{"lat":37,"lon":36},[40],{"name":23,"role":24,"phone":20,"phoneExt":20,"email":25},{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Lu Xuzhang","Director, Department of Hematology, Principal Investigator","100650180","phase-2-pirtobrutinibpola-r-chp-for-newly-diagnosed-non-gcb-dlbcl-100650180",false,"NCT07744724","Pirtobrutinib+Pola-R-CHP for Newly Diagnosed Non-GCB DLBCL","A Prospective, Multicenter Clinical Study of Pirtobrutinib Combined With Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone (Pola-R-CHP) for Newly Diagnosed Non-GCB Diffuse Large B-Cell Lymphoma (DLBCL)","Inclusion Criteria:\n\n1. Histologically confirmed Non-GCB DLBCL (per 2016 WHO diagnostic criteria);\n2. Whole-body PET\u002FCT performed within 28 days prior to study enrollment demonstrating at least one measurable lesion (per 2014 Lugano criteria);\n3. Age 18-65 years, with expected survival \\>3 months;\n4. No prior anti-lymphoma treatment;\n5. Signed written informed consent and ability to comply with protocol-required visits and procedures;\n6. ECOG performance status 0-2;\n7. Adequate organ and bone marrow function, defined as follows:\n\n   * Hematology: Absolute neutrophil count (ANC) ≥1×10⁹\u002FL, platelet count (PLT) ≥50×10⁹\u002FL, hemoglobin (HGB) ≥8.0 g\u002FdL; no granulocyte colony-stimulating factor, platelet transfusion, or red blood cell transfusion within 7 days prior to testing;\n   * Hepatic function: Total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN;\n   * Renal function: Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCR) ≥50 mL\u002Fmin;\n   * Cardiac function: NYHA Class III or below; left ventricular ejection fraction ≥50% by echocardiography;\n   * Coagulation: International normalized ratio (INR) ≤1.5×ULN, activated partial thromboplastin time (APTT) ≤ULN +10s, and prothrombin time (PT) ≤ULN +3s;\n8. Women of childbearing potential or male subjects with partners of childbearing potential must use effective contraception throughout the treatment period and for 90 days after the last dose.\n\nExclusion Criteria:\n\n1. Central nervous system involvement;\n2. History of hypersensitivity to the study drug, drugs of the same class, or excipients;\n3. Concurrent malignancy requiring treatment or intervention;\n4. Major surgery within 4 weeks prior to treatment (excluding vascular access catheter placement or biopsy);\n5. Presence of any life-threatening disease, medical condition, or organ system dysfunction that, in the investigator's opinion, may affect patient safety or compliance with study procedures;\n6. Uncontrolled cardiac symptoms or disease, including: i. NYHA Class II or higher heart failure; ii. Unstable angina; iii. Myocardial infarction within 1 year; iv. Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;\n7. Active bleeding;\n8. Active, uncontrolled systemic bacterial, viral, fungal, or parasitic infection (excluding onychomycosis), or other clinically significant active disease process that, in the investigator's opinion, renders the patient unsuitable for clinical trial participation;\n9. Known history of human immunodeficiency virus (HIV) infection and\u002For acquired immunodeficiency syndrome;\n10. Exclusion of patients with active chronic hepatitis B or active hepatitis C. Patients with positive hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C virus antibody at screening must undergo further HBV-DNA and HCV-RNA testing. Patients with stable hepatitis B (HBV-DNA \\\u003C2500 copies\u002FmL or 500 IU\u002FmL) on antiviral therapy and cured hepatitis C patients (below the limit of detection) may be enrolled;\n11. Definitive history of neurological or psychiatric disorder, including epilepsy or dementia;\n12. Pregnant or lactating women;\n13. Receipt of other investigational agents within 1 month prior to first dose;\n14. Any other factors that, in the investigator's opinion, may affect the evaluation of efficacy or safety in this study.","ALL","18 Years","65 Years",{"count":56,"type":57},48,"ESTIMATED","INTERVENTIONAL",[60],"PHASE2",[62,63],"DLBCL - Diffuse Large B Cell Lymphoma","Pirtobrutinib","NOT_YET_RECRUITING","2026-08-04",{"date":67,"type":68},"2026-08-06","ACTUAL",{"date":70,"type":57},"2026-07-31",{"date":72,"type":57},"2030-07-31",{"name":5,"class":6},1]