Zanubrutinib Plus GCVP (Obinutuzumab, Cyclophosphamide, Vindesine, Prednisolone) in Previously Untreated Follicular Lymphoma

This is a prospective, single-arm, multi-center, phase II clinical study aiming at evaluating the efficacy and safety of zanubrutinib with GCVP (obinutuzumab, cyclophosphamide, vindesine, prednisolone) in untreated follicular lymphoma (FL). It includes screening (14 days before the first dose), treatment, and follow-up phases. Screening: Recruitment subjects are grade 1-3a, stage III/IV or extensive stage II (unsuitable for radiotherapy) FL patients, with measurable lesions (short axis ≥1.5cm), meeting GELF criteria or having strong treatment desire. Treatment: Patients receive the ZGCVP regimen for 6 cycles (21-day/cycle). Imaging evaluation was conducted at the end of every 2 cycles. Enhanced Computed Tomography (CT) and ultrasound are performed after 2 cycles of the ZGCVP regimen, while interim Positron Emission Tomography (iPET) is performed after 4/6 cycles. Bone marrow examination is required for those with initial bone marrow involvement after achieving Imaging complete response. Efficacy assessment indicators include complete response rate (CR), objection response rate (ORR), duration of response (DOR), progression free survival (PFS), overall survival (OS) and disease transformation rate according to Lugano 2014 criteria. Safety assessment indicators inlude adverse events basing on CTCAE 5.0. Follow-up: Patients achieving CR at stage II underwent observation directly; those at stage III/IV receive obinutuzumab maintenance every 8 weeks for 2 years until disease progression or withdrawal. Patients with disease progression during treatment switch to second-line therapy.