A Prospective, Multicenter, Single-Arm, Open-Label Phase 2 Study of Chidamide Maintenance in Patients With Newly Diagnosed Double-Expressor Diffuse Large B-Cell Lymphoma Who Achieve Complete Response After Induction Therapy But Remain ctDNA MRD-Positive
This is a prospective, multicenter, single-arm, open-label phase 2 study designed to evaluate the efficacy and safety of chidamide maintenance in adults with newly diagnosed double-expressor diffuse large B-cell lymphoma (DLBCL) who achieve complete response after induction therapy but remain ctDNA minimal residual disease (MRD)-positive. Eligible participants will receive oral chidamide 20 mg on Days 1, 4, 8, and 11 of each 21-day cycle. ctDNA MRD will be assessed every 12 weeks. Treatment will continue until two consecutive MRD-negative assessments, disease progression, intolerable toxicity, withdrawal of consent, or completion of 2 years of maintenance. The primary objectives are to evaluate ctDNA MRD negativity and 2-year progression-free survival. Secondary objectives include event-free survival, overall survival, and safety.
• 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.