A Real-World Study of Pirtobrutinib in cBTKi-Resistant/Intolerant Mature B-Cell Lymphoma

• Age ≥18 years;
• Histopathological confirmation of mature B-cell lymphoma, primarily including CLL/SLL, MCL, FL, MZL, WM/LPL, etc.;
• Disease progression and/or intolerance after prior treatment with ≥1 cBTKi (including ibrutinib, ibrutinib, zanubrutinib, or acitinib);
• ECOG PS 0-2;
• Adequate liver and kidney function: the following criteria must be met simultaneously: 1) AST and ALT ≤ 3×ULN; 2) Total bilirubin ≤ 1.5×ULN; 3) Creatinine clearance rate ≥ 30 mL/min;
• Participants must be voluntary and capable of completing the study procedures and follow-up examinations;
• Informed consent must be obtained voluntarily prior to screening.

Exclusion Criteria:

• Patients with known allergic reactions to any component or excipient of piteutinib;
• Patients concurrently participating in other clinical studies;
• A history of clinically significant, uncontrolled cardiac,
• Cardiovascular disease, or myocardial infarction within 6 months prior to planned initiation of piteutinib therapy;
• Uncontrolled systemic bacterial, viral, fungal, or parasitic infections; current use of potent CYP3A4 inhibitors or inducers and/or potent P-gp inhibitors;
• Positive human immunodeficiency virus (HIV) testing;
• Active hepatitis B or C: 1) Patients with positive hepatitis B virus (HBV) DNA testing and controlled disease status may be enrolled with investigator approval. For HBV DNA-positive patients, concurrent antiviral therapy is required. 2) Patients with prior hepatitis C virus (HCV) infection history who have completed antiviral therapy with viral loads below the quantitative limit may be enrolled;
• Based on the investigator's assessment, participants may be unable to complete all study protocol requirements, including follow-up visits, and/or adhere to all study procedures;
• A history of other clinically significant diseases or comorbidities; and any safety risks or potential interference with study completion as evaluated by investigators.