Orelabrutinib Combined With Pola-R-CHP Regimen for the Treatment of Untreated Non-GCB Diffuse Large B-Cell Lymphoma

Prior treatment

• Need for continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers.
• Other concurrent and uncontrolled medical conditions that the investigator believes will affect the patient's participation in the study.

Other illness

• Patients with psychiatric disorders or other known or suspected inability to fully comply with the study protocol.
• Known human immunodeficiency virus (HIV) infection, or active hepatitis B or C virus infection (positive result by polymerase chain reaction \[PCR\]). If the patient tests positive for HbsAg, HBV DNA testing is required. If HBV DNA \<10³ IU/ml, the patient may be enrolled. If the patient tests negative for HbsAg but positive for HBcAb (regardless of HBsAb status), HBV DNA testing is also required. If HBV DNA \<10³ IU/ml, the patient may be enrolled. If the patient tests positive for HCV antibody, HCV RNA is detected by PCR. If positive, the patient meets the exclusion criteria.
• Inability to swallow capsules or significant gastrointestinal disorders, such as malabsorption syndrome, bariatric surgery, inflammatory bowel disease, or partial or complete intestinal obstruction.

Lab values

• Laboratory values at screening (unless due to lymphoma):
  • Neutrophils \<1.5×10⁹/L;
  • Platelets \<75×10⁹/L;
  • ALT or AST more than 2 times the upper limit of normal, ALP and bilirubin more than 1.5 times the upper limit of normal;
  • Creatinine level more than 1.5 times the upper limit of normal.

Other

• Lymphoma involving the central nervous system or leptomeningeal metastasis.
• Transformed lymphoma, that is, transformed from other types of lymphoma, such as follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia, or small B-cell lymphoma.
• Primary mediastinal large B-cell lymphoma.
• Burkitt lymphoma.
• Pregnant or breastfeeding women.

• Age 18 to 80 years old.
• Diffuse large B-cell lymphoma (DLBCL) confirmed by tumor tissue pathology, with at least one measurable lesion.
• Non-GCB.
• No prior anti-tumor treatment.
• ECOG score of 0-2.
• Life expectancy of ≥6 months.
• Voluntary written informed consent.