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

Launched by RUIJIN HOSPITAL · Mar 28, 2025

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Eligibility criteria

• 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.-
• Exclusion Criteria:
• • Contraindications to any of the drugs included in the treatment regimen.
• • History of active liver disease, including viral or other hepatitis or liver cirrhosis (Hepatitis B is defined as HBV-DNA exceeding the upper limit of normal; active Hepatitis C is defined as seropositive for HCV antibodies, but patients with HCV-RNA negative results can be included).
• • Human immunodeficiency virus (HIV) infection.
• • Congestive heart failure classified as greater than NYHA Class II by the New York Heart Association; history of acute myocardial infarction, unstable angina, stroke, or transient ischemic attack within the past six months.
• • Congenital long QT syndrome or QTc \> 480 ms (Note: QTc must be calculated using Friederica's formula: QTcF = QT / (RR)\^0.33).
• • Pregnant or breastfeeding women, or those planning to become pregnant during the study.
• • History of confirmed neurological or psychiatric disorders, or a history of substance abuse or drug addiction.