This study is a prospective, open-label, multicenter study in previously untreated participants with CD20-positive DLBCL. Orelabrutinib combined with standard immunochemotherapy with or without autologous hematopoietic stem cell transplantation (auto-HSCT) for newly diagnosed diffuse large B-cell lymphoma (DLBCL). The primary objective is to explore the 1-year progression-free survival (PFS) of orelabrutinib combined with standard immunochemotherapy with or without auto-HSCT in newly diagnosed DLBCL.
Signed informed consent;
Age 18-80 years at the time of signing informed consent, and willingness to comply with the study protocol procedures;
Pathologically confirmed CD20-positive DLBCL;
Hemoglobin ≥90 g/L within 7 days prior to enrollment without packed red blood cell transfusion;
Presence of uncontrolled cardiovascular or cerebrovascular disease, coagulation disorders, autoimmune diseases, severe infectious diseases, etc.;
Coagulation function: INR > 1.5× the upper limit of normal (ULN); PT and APTT > 1.5× ULN;
Liver function: ALT or AST > 2× ULN; ALP and bilirubin > 1.5× ULN;
Renal function: Creatinine > 1.5× ULN; creatinine clearance < 60 mL/min (estimated by the Cockcroft-Gault formula);