Zanubrutinib Combined With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in the Treatment of Newly Diagnosed Diffuse Large B-cell Lymphoma With p53 Protein Expression
This study aim to evaluate the efficacy and safety of zanubrutinib combined with R-CHOP in the treatment of DLBCL patients with p53 protein expression.
• Age ≥18 years, ≤ 75 years, both sexes;
• Diff use large B-cell lymphoma diagnosed by histopathology without previous systemic DLBCL treatment;
• ECOG score: 0-2;
• Predicted survival ≥3 months;
• Patients with positive p53 expression detected by immunohistochemistry (≥50% );
• The patients had certain conditions of organ function reserve, and the laboratory tests within 1 week before enrollment met the following conditions:
⁃ Blood routine: neutrophil count (NEUT) ≥1.5×10\^9/L, platelet count (PLT)
⁃ ≥75×10\^9/L, hemoglobin (HGB) ≥80 g/L; G-CSF was not used in the past 7 days (the researchers judged that the lymphoma-induced cytopenia could be included).
⁃ Liver function: Total bilirubin (TBIL) ≤1.5× upper limit of the normal range (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; If liver metastases were present, TBIL≤3×ULN, ALT and AST≤5×ULN; Renal function: serum creatinine (Cr) ≤2.0×ULN or creatinine clearance (CCr) ≥60ml/min;
⁃ Cardiac function: LVEF≥50%, ECG did not indicate any acute myocardial infarction, arrhythmia, or atrioventricular conduction block above grade I;
⁃ Thyroid function: thyroid stimulating hormone (TSH) was within the normal range. If TSH is abnormal, free triiodothyronine (FT3) and free thyroxine (FT4) should be within the normal range or abnormal without clinical significance.
• According to the Lugano2014 assessment criteria, patients must have measurable lesions, defined as the longest diameter of at least one nodule \> 1.5cm, or the longest diameter of at least one nodule \> 1cm, and at least two vertical diameters that can be accurately measured.
• Patients volunteered to participate in the trial, understood the study procedure, and were able to sign in-person informed consent.