Chidamide Maintenance for MRD-Positive Double-Expressor DLBCL in First Complete Remission

Korábbi kezelés

• Prior organ transplantation.
• Major organ surgery within 6 weeks before screening.
• Drug abuse or chronic alcohol abuse that may interfere with study evaluation.
• Requirement for ongoing treatment with strong or moderate CYP3A inhibitors or inducers; patients exposed to these agents within 7 days before first study dose, or within fewer than 5 half-lives, are not eligible.

Más betegség

• Failure to achieve complete response after initial induction therapy.
• Uncontrolled coagulopathy or active bleeding.
• Active hepatitis B not meeting protocol-defined virologic criteria for enrollment; patients with positive HBsAg or positive HBcAb require HBV DNA testing and must meet protocol-specified thresholds.
• HIV infection.
• Ongoing antitumor therapy for lymphoma or another malignancy.
• Psychiatric illness or any condition resulting in inability to comply with the protocol.
• Inability to swallow capsules or clinically significant gastrointestinal disorders that may affect drug absorption, including malabsorption syndrome, bariatric surgery, inflammatory bowel disease, or partial/complete bowel obstruction.
• Any other uncontrolled medical condition that, in the investigator's judgment, may compromise safety, interfere with oral drug absorption or metabolism, or place the participant at excessive risk.

Laborértékek

• Uncontrolled cardiovascular or cerebrovascular disease, including left ventricular ejection fraction <50%, connective tissue disease, or severe active infection.
• Screening laboratory abnormalities not attributable to lymphoma, including: neutrophil count <1.5 x 10\^9/L; platelet count <80 x 10\^9/L (or <50 x 10\^9/L in patients with bone marrow involvement); total bilirubin >1.5 x upper limit of normal; ALT/AST >2.5 x upper limit of normal, or >5 x upper limit of normal in patients with hepatic involvement; serum creatinine >1.5 x upper limit of normal.

• Histologically confirmed diffuse large B-cell lymphoma, CD20-positive.
• Double-expressor lymphoma confirmed by pathology, defined as MYC expression >=40% and BCL2 expression >=50% by immunohistochemistry.
• Complete response after initial induction therapy.
• Age >=18 and <=80 years.
• ECOG performance status 0-2.
• No prior history of malignant tumor and no concurrent malignancy.
• International Prognostic Index (IPI) score >1.
• ctDNA MRD-positive at screening/enrollment.
• Life expectancy of at least 6 months, in the opinion of the investigator.
• Written informed consent provided before any study-specific procedure.