A Prospective, Open-label, Single-arm Multicenter Clinical Study of Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) in the Treatment of Untreated Follicular Lymphoma
This study is planned to prospectively evaluates the efficacy and safety of the zanubrutinib, obinutuzumab, and lenalidomide (ZGR) combination regimen in treatment-naïve follicular lymphoma (FL) patients in a Chinese population.
• Gender: No restrictions; age ≥18 years.
• Diagnosis: Histologically confirmed CD20-positive follicular lymphoma (FL), Grade 1, 2, or 3A, per 2016 WHO classification. All patients must provide sufficient archived or fresh tumor tissue samples for immunohistochemical (IHC) analysis.
• Disease Stage \& Treatment Need:
• Stage III or IV disease, or Stage II with bulky disease, meeting at least one of the following criteria:
• a) Bulky disease: Lymph node or extranodal (excluding spleen) mass with maximum diameter ≥7 cm.
• b) Local symptoms or organ dysfunction due to progressive lymphadenopathy or extranodal tumor mass.
• c) B symptoms (fever, night sweats, or unintentional weight loss \>10% of body weight within ≤6 months).
• d) Symptomatic extranodal involvement (e.g., pleural/peritoneal effusion).
• e) Cytopenias due to bone marrow infiltration (hemoglobin \<10 g/dL, absolute neutrophil count \[ANC\] \<1.0×10⁹/L, platelets \<100×10⁹/L).
• f) Involvement of ≥3 lymph nodes, each ≥3 cm in diameter.
• g) Symptomatic splenomegaly.
• Prior Therapy: No prior systemic therapy for FL.
• ECOG Performance Status: ≤2.
• Measurable Disease: At least one measurable lesion (\>2 cm in longest diameter by CT/MRI).
• Life Expectancy: ≥6 months.
• Adequate Organ Function:
• a) ANC ≥1.0×10⁹/L (without growth factor support).
• b) Platelets ≥50×10⁹/L (untransfused within 7 days).
• c) Total bilirubin (TBIL) ≤1.5×ULN.
• d) ALT/AST ≤3×ULN.
• e) Creatinine clearance ≥30 mL/min (calculated by modified Cockcroft-Gault formula).
• Contraception: Men and women of childbearing potential must agree to use highly effective contraception during the study and for 4 weeks after treatment discontinuation.
• Informed Consent: Patients must voluntarily participate and sign informed consent forms (ICF).