Methotrexate or Thiotepa Combined With R-CHOP and Orelabrutinib in CNSL Patients

Inclusion Criteria

• •Fully understand the study and voluntarily sign the informed consent form.
• •Age: 14-80 years.
• •Expected survival of more than 3 months, as determined by the investigator.
• •Pathologically or cytologically confirmed diffuse large B-cell lymphoma (DLBCL) of B-cell origin through pathology or flow cytometry.
• •Central nervous system (CNS) involvement, confirmed by at least one of the following:
• •1. Symptoms related to CNS involvement.
• •2. Abnormal findings on imaging.
• •3. Pathological evidence (positive cerebrospinal fluid cytology, positive brain lesion biopsy or positive cerebrospinal fluid ctDNA).
• •Any non-hematologic toxicity related to prior treatments must have resolved to Grade 1 or normal levels (per NCI CTCAE Version 5.0), except for alopecia.
• •Bone marrow and organ function must meet the following criteria (without blood transfusion, G-CSF administration, or pharmacological correction within 14 days prior to screening):
• •Bone marrow function:
• •1)Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L. 2)Platelet count ≥ 50 × 10⁹/L. 3)Hemoglobin ≥ 60 g/L.
• •Liver function:
• •1. Total bilirubin ≤ 1.5 × ULN (≤ 3.0 × ULN if liver metastasis is present).
• •2. AST and ALT ≤ 2.5 × ULN (≤ 5.0 × ULN if liver metastasis is present).
• •Coagulation function:
• •International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.
• •Renal function: Serum creatinine ≤ 1.5 × ULN or estimated creatinine clearance rate ≥ 30 mL/min (calculated using the Cockcroft-Gault formula): Male: Cr (mL/min) = (140 - age) × weight (kg) / \[72 × serum creatinine (mg/dL)\]. Female: Cr (mL/min) = (140 - age) × weight (kg) / \[85 × serum creatinine (mg/dL)\].
• •Women of childbearing potential (WOCBP) and men with reproductive potential must agree to use effective contraception during the study and for 3 months after discontinuing treatment.
• •Good compliance, with willingness to adhere to visit schedules, dosing regimens, laboratory tests, and other study procedures.-