This study intends to conduct a prospective, multicenter, open-label, randomized controlled clinical trial to systematically evaluate the efficacy and safety of the orelabrutinib plus obinutuzumab and lenalidomide (RO2) regimen versus the obinutuzumab-combined chemotherapy (O-chemo) regimen in patients with previously untreated follicular lymphoma. The primary observation is whether the RO2 regimen can maintain or improve therapeutic efficacy while significantly reducing hematological toxicities and other related adverse reactions, so as to provide a novel therapeutic option for improving the prognosis and quality of life of patients with follicular lymphoma (FL).
Subjects with histopathologically confirmed follicular lymphoma (FL) Grade 1-3A;
Subjects who have never received prior anti-lymphoma therapy;
Age ≥ 18 years old;
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
Uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, etc.
Absolute neutrophil count < 1.5 × 10⁹/L
Platelet count < 80 × 10⁹/L; if bone marrow involvement is present, platelet count < 50 × 10⁹/L
Alanine transaminase (ALT) or aspartate transaminase (AST) > 2 × upper limit of normal (ULN); alkaline phosphatase (AKP) or bilirubin > 1.5 × ULN