PI3K Inhibitors for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas

Exclusion Criteria13

• Here is the translated text:
• Subjects who have previously used any PI3K inhibitors;
• Clinical conditions of dysphagia, malabsorption, or other chronic gastrointestinal diseases that may interfere with compliance and/or absorption of the study drug;
• Unable to discontinue medications that may prolong the QT interval (such as antiarrhythmic drugs) during the study period;
• Active viral, bacterial, or fungal infections requiring treatment (e.g., pneumonia);
• HBV or HCV infection (defined as HBsAg and/or HBcAb positive with HBV DNA copy number ≥ upper limit of normal reference value) or acute or chronic active hepatitis C (HCV) antibody positive;
• History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation, or history of allogeneic bone marrow or hematopoietic stem cell transplantation;
• Received autologous hematopoietic stem cell transplantation within 90 days before the first dose of study treatment;
• Presence of severe or uncontrolled cardiovascular disease;
• Presence of severe concomitant diseases that endanger patient safety or are deemed by the investigator to affect the completion of the study (e.g., uncontrolled hypertension, diabetes, thyroid disease);
• Pregnant or breastfeeding female patients, or baseline pregnancy test positive for women of childbearing potential;
• Diagnosed or treated for other malignancies within the past 5 years;
• Any other condition that the investigator deems unsuitable for participation in the study.