A Prospective, Exploratory Clinical Study of Genetic Subtype-matched Precision Targeted Therapy in Newly Diagnosed DLBCL With TP53 Mutation
To evaluate the efficacy and safety of Genetic subtype-matched targeted therapy in the treatment of treatment-naive diffuse large B-cell lymphoma with TP53 mutation.
• Patients aged 18 years and older, up to 70 years.
• Participants must be able to understand and willing to sign the written informed consent form.
• Eastern Cooperative Oncology Group performance status 0 to 3.
• Life expectancy ≥3 months (as determined by the investigator).
• Pathologically (histologically or cytologically) confirmed treatment-naive CD20-positive diffuse large B-cell lymphoma.
• Measurable disease defined by PET-CT as a short-axis diameter of at least ≥1.5 cm.
• Bone marrow and organ function meeting the following criteria (without blood transfusion, G-CSF, or medication correction within 14 days prior to screening):
• Bone marrow function: Absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥80×10⁹/L, hemoglobin ≥80 g/L.
• Liver function: Total serum bilirubin ≤1.5×ULN (≤3.0×ULN if liver metastases present); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN (≤5.0×ULN if liver metastases present).
• Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time ≤1.5×ULN.
• Renal function: Serum creatinine ≤1.5×ULN or estimated creatinine clearance ≥60 mL/min (for males: Cr (mL/min) = (140 - age) × body weight (kg) / \[72 × serum creatinine concentration (mg/dL)\]; for females: Cr (mL/min) = (140 - age) × body weight (kg) / \[85 × serum creatinine concentration (mg/dL)\]).
• Females of childbearing potential must agree to use highly effective contraceptive methods during the treatment period and for 5 weeks after the last dose of study drug. Sexually active males must agree to use highly effective contraception during the treatment period and for 3 months after the last dose.
• No difficulty swallowing oral tablets/capsules.
⁃ Good compliance and willingness to adhere to visit schedules, dosing schedules, laboratory tests, and other examination procedures.