Study of Chidamide as Maintenance Therapy for Patients with HBV-Infected Diffuse Large B-Cell Lymphoma After Initial R-CHOP Treatment A Phase 3 Clinical Trial Evaluating Safety and Effectiveness

What this Trial Is About

Researchers are evaluating the effectiveness and safety of chidamide as a maintenance treatment for patients with diffuse large B-cell lymphoma DLBCL who also have hepatitis B virus HBV infection. These patients must have responded to initial treatment with R-CHOP chemotherapy. The goal is to provide clinical evidence for using chidamide in this specific patient group. This is a phase III, open-label, multicenter trial led by Ou Bai, MDPhD. Participants are randomly assigned to one of two groups the experimental group receiving chidamide or the control group receiving observation. Chidamide is given at 20 mg twice weekly on specified days within a 4-week cycle. All participants receive standardized antiviral drugs, such as Entecavir 0.5 mg daily, to manage HBV infection. The treatment cycles and antiviral therapy continue as part of the maintenance phase after initial chemotherapy. During the study, participants undergo regular assessments including imaging scans and lab tests to monitor disease progression and overall health. The main measure of success is progression-free survival at 2 years. Researchers also evaluate overall survival, safety, and biomarkers. Participants are monitored for side effects and treatment response over the trial period, which lasts until September 2030.

Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP