Phase II Study of Chidamide with R-mini CHOP Followed by Chidamide Plus CD20 Maintenance in Elderly Patients with Newly Diagnosed MYCBCL2 Double-Expressor Diffuse Large B-Cell Lymphoma

What this Trial Is About

This research aims to evaluate the effectiveness and safety of chidamide combined with the R-mini CHOP regimen in elderly patients newly diagnosed with MYCBCL2 double-expressor diffuse large B-cell lymphoma DLBCL. The study focuses on the 2-year progression-free survival rate and also looks at response rates, duration of response, overall survival, and safety. Researchers will explore how biomarkers and circulating tumor DNA relate to treatment outcomes. Participants will receive chidamide orally at 20 mg twice a week for 14 days in each 21-day cycle alongside the R-mini CHOP chemotherapy regimen given every 3 weeks during the induction phase. Following this, a maintenance phase includes chidamide at the same dosing schedule combined with rituximab administered intravenously once every 12 weeks, continuing in 21-day cycles. The study is designed as a single-arm, open-label phase II trial. During the study, participants will undergo regular clinical evaluations, laboratory tests, and imaging scans such as PET-CT to monitor treatment response and safety over 24 months. Researchers will record objective response rates, complete response rates, and adverse events throughout. The study also involves biomarker and genomic analyses to assess correlations with treatment efficacy. Participants overall survival and conversion rates from partial or stable disease to better responses will be closely followed.

Chidamide Combination With R-mini CHOP Followed by Chidamide+CD20 Maintenance in Elderly Newly Diagnosed MYC/BCL2+ DLBCL