Efficacy and Safety of Lisaftoclax (APG-2575) Monotherapy in Patients With Indolent Lymphoma

Exclusion criteria

• . Prior treatment with any B-cell lymphoma 2 (BCL-2) inhibitor.
• . Patients with active infection (including active hepatitis B virus \[HBV\] or hepatitis C virus \[HCV\] infection, or human immunodeficiency virus \[HIV\] positivity) or any other serious uncontrolled medical condition (Patients who are hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) seropositive are eligible if their HBV DNA is below the lower limit of detection/quantification and they are willing to undergo monthly HBV reactivation monitoring. Patients who are HCV antibody positive are eligible if their HCV RNA is below the lower limit of detection/quantification).
• . Presence of other concurrent malignancies (except for those specified in the inclusion criteria) that may affect the interpretation of study results or treatment with the investigational drug, or patients with severe coagulation disorders, or severe impairment of cardiac, cerebral, pulmonary, hepatic, or renal function.
• . History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 12 months prior to the first dose of the study drug.
• . Administration of any live vaccine within 28 days prior to the first dose of the study drug.
• . Women of childbearing potential (WOCBP) or men with partners of childbearing potential who are unwilling to use highly effective contraception; pregnant or breastfeeding women.
• . Inability to swallow tablets, or presence of malabsorption syndrome, any disease significantly affecting gastrointestinal function, gastrectomy/small bowel resection, symptomatic inflammatory bowel disease or ulcerative colitis, or partial/complete bowel obstruction.
• . Known hypersensitivity to the active pharmaceutical ingredient, excipients of the study drug, or its analogs.