Pirtobrutinib+Pola-R-CHP for Newly Diagnosed Non-GCB DLBCL

Korábbi kezelés

• Concurrent malignancy requiring treatment or intervention;
• Major surgery within 4 weeks prior to treatment (excluding vascular access catheter placement or biopsy);
• Receipt of other investigational agents within 1 month prior to first dose;

Más betegség

• History of hypersensitivity to the study drug, drugs of the same class, or excipients;
• 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;
• 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;
• Active bleeding;
• 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;
• Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome;
• 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 <2500 copies/mL or 500 IU/mL) on antiviral therapy and cured hepatitis C patients (below the limit of detection) may be enrolled;
• Definitive history of neurological or psychiatric disorder, including epilepsy or dementia;

Egyéb

• Central nervous system involvement;
• Pregnant or lactating women;
• Any other factors that, in the investigator's opinion, may affect the evaluation of efficacy or safety in this study.

• Histologically confirmed Non-GCB DLBCL (per 2016 WHO diagnostic criteria);
• Whole-body PET/CT performed within 28 days prior to study enrollment demonstrating at least one measurable lesion (per 2014 Lugano criteria);
• Age 18-65 years, with expected survival >3 months;
• No prior anti-lymphoma treatment;
• Signed written informed consent and ability to comply with protocol-required visits and procedures;
• ECOG performance status 0-2;
• Adequate organ and bone marrow function, defined as follows:
  • Hematology: Absolute neutrophil count (ANC) ≥1×10⁹/L, platelet count (PLT) ≥50×10⁹/L, hemoglobin (HGB) ≥8.0 g/dL; no granulocyte colony-stimulating factor, platelet transfusion, or red blood cell transfusion within 7 days prior to testing;
  • Hepatic function: Total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN;
  • Renal function: Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCR) ≥50 mL/min;
  • Cardiac function: NYHA Class III or below; left ventricular ejection fraction ≥50% by echocardiography;
  • Coagulation: International normalized ratio (INR) ≤1.5×ULN, activated partial thromboplastin time (APTT) ≤ULN +10s, and prothrombin time (PT) ≤ULN +3s;
• 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.