Zanubrutinib in Combination With Obinutuzumab (ZO) for Newly Diagnosed Follicular Lymphoma

Exclusion Criteria12

• HBV-positive serology (concealed carriers: anti-HBeAg +, HbsAg-, anti-HBsAg +/-) Enrollment only if HBV-DNA test is negative;
• Normal major organ function: liver function serum bilirubin ≤ 2.0 × ULN , serum ALT and AST ≤ 2.5 × ULN, renal function: serum Cr ≤ 2.0 × ULN; (unless due to lymphoma);
• Informed consent (patients must sign an informed consent form for all studies).
• Medically significant CNS lymphoma or molluscum contagiosum or large cell transformation;
• HIV-positive patients and or HCV active infection (documented by HCV-RNA positive test);
• Patients should not have active or uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia Patients should not have transfusion-dependent thrombocytopenia or bleeding disorders Patients should not have autoimmune disorders associated with the study drug;
• Known bleeding disorders (e.g., vascular hemophilia or hemophilia) in combination with warfarin or other vitamin K antagonists require treatment with a potent cytochrome P450 (CYP) 3A inhibitor;
• Patients with acute coronary syndrome within 6 months prior to study entry must not have had a stroke or intracranial hemorrhage within the past 6 months Prior Surgery: no major surgery within 28 days prior to enrollment or minor surgery within 7 days prior to enrollment; examples of minor surgery include dental procedures, venous access device insertion, skin biopsies, or joint aspirations; procedures may be major or minor at the discretion of the treating physician;
• Severe COPD with combined hypoxemia;
• Active bacterial, fungal, and, or viral infections not controlled by systemic therapy;
• In addition to cured basal cell carcinoma of the skin or cervical cancer in situ or early prostate cancer that does not require systemic therapy, or early breast cancer that requires surgery alone. Other malignant tumors within the last 2 years or concurrently;
• Pregnancy and Lactation: Female patients must have a negative serum pregnancy test within 72 hours prior to initiation of regimen therapy and use effective contraception during regimen therapy and for at least 12 weeks after completion of the study.