Phase II Study of Chidamide Plus R-CHOP Combined with Targeted Drugs for Newly Diagnosed Diffuse Large B-cell Lymphoma with MYC and BCL2 Double Expression

What this Trial Is About

This research aims to evaluate the effectiveness and safety of a treatment regimen called CR-CHOP combined with different targeted drugs based on specific molecular subtypes in patients newly diagnosed with diffuse large B-cell lymphoma DLBCL with double expression of MYC and BCL2. This is a prospective, open-label phase II clinical trial focusing on this particular lymphoma subtype to better understand treatment responses and outcomes. Participants first receive one course of CR-CHOP chemotherapy. After this initial cycle, their treatment is tailored for the remaining five cycles according to their genetic subtype one group receives CR-CHOP plus a PD1 inhibitor, another group receives CR-CHOP with Orelabrutinib, and a third group with TP53 mutation receives CR-CHOP plus Decitabine. Following chemotherapy, patients with complete or partial response continue their assigned treatment, while those with stable or progressive disease may be recommended for second-line salvage therapy. Patients achieving a complete response after all treatments are recommended to receive maintenance therapy with chidamide for two years or until unacceptable toxicity or disease progression. Throughout the study, patients undergo routine evaluations after each treatment cycle and a comprehensive assessment of treatment effectiveness after three cycles. The primary outcome is the complete response rate assessed 6-8 weeks after the last dose of the sixth cycle. Secondary outcomes include progression-free survival, overall survival, and overall response rate over two years. Safety and treatment adherence are monitored, and patients may be followed for up to two years to assess long-term outcomes and maintenance therapy effects.

CR-CHOP+X in Previously Untreated DEL