Zanubrutinib, Obinutuzumab Combined With Lenalidomide (ZGR) for the Treatment of Untreated Follicular Lymphoma

Ki vehet részt

• 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)

Ki nem vehet részt

• Use of any investigational drugs, antibiotics, or participation in another interventional clinical trial within 4 weeks prior to enrollment
• Major surgery (excluding lymph node biopsy) within 14 days before enrollment or anticipated need for major surgery during the study
• Prior treatment with zanubrutinib, obinutuzumab, or lenalidomide
• Immunodeficiency or autoimmune disease history, or chronic systemic steroid therapy (>10 mg/day prednisone equivalent) or immunosuppressive therapy within 7 days before enrollment
• Severe hepatic dysfunction (including severe jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome), cachexia, or multi-organ failure with renal impairment
• NYHA Class III/IV heart failure
• HIV, active hepatitis B/C infection (HBV DNA ≥2000 IU/mL or HCV RNA detectable)
• Uncontrolled systemic infections
• Bleeding disorders or coagulation abnormalities, or thrombotic events within 3 months
• Severe hypersensitivity to the active ingredients or excipients of the study drugs
• Other conditions deemed unsuitable by the investigator
• Myocardial infarction within 6 months before enrollment, Malignant arrhythmias (including QTc ≥480 ms), Uncontrolled hypertension (Systolic blood pressure (SBP) ≥150 mmHg and diastolic blood pressure (DBP) ≥100 mmHg), Unstable angina; Active infections:
• Prior history of malignancy, unless the patient has been disease-free for ≥5 years and the treating physician deems the risk of recurrence low (exceptions: non-melanoma skin cancer, cured localized prostate cancer, carcinoma in situ of the cervix, or squamous intraepithelial lesions on PAP smear)
• Patients meeting any of the following criteria will be excluded from this study:
• Histologic evidence of central nervous system (CNS) lymphoma, leptomeningeal lymphoma, or transformation to high-grade lymphoma (e.g., diffuse large B-cell lymphoma, DLBCL)
• Grade 3B follicular lymphoma (FL) or transformed FL
• Ann Arbor Stage I FL
• Clinically significant cardiovascular abnormalities:
• Pregnancy, lactation, or unwillingness to use effective contraception in women of childbearing potential