Phase II Trial of CRP Regimen Chidamide, Rituximab, Polatuzumab Vedotin for Elderly Patients with Untreated Double-Positive Diffuse Large B-Cell Lymphoma

What this Trial Is About

Researchers are evaluating the CRP regimen, which includes Chidamide, Rituximab, and Polatuzumab Vedotin, in elderly patients who have previously untreated double-expressor diffuse large B-cell lymphoma DLBCL. This Phase II, single-arm, open-label, multicenter trial focuses on assessing the feasibility, efficacy, and safety of this combination treatment in this specific patient group. Participants receive a combination therapy of Chidamide, Rituximab, and Polatuzumab Vedotin for up to six cycles, each lasting 21 days. Chidamide is given using a step-dose escalation schedule, while Rituximab and Polatuzumab Vedotin are administered on Day 1 of each cycle. Patients who achieve partial or complete response after combination therapy may continue with Chidamide maintenance therapy for one year at a dose of 20 mg twice weekly, adjusted based on tolerance. During the study, participants will be carefully monitored through laboratory tests and imaging to evaluate treatment response and safety. The primary outcome measured is the complete response rate by the end of treatment. Secondary outcomes include overall response rate, progression-free survival, event-free survival, overall survival, treatment-related adverse events, and quality of life assessments over a follow-up period of up to two years. The total study duration extends through treatment and long-term follow-up to assess lasting effects and safety.

CRP Regimen in Treating Elderly Patients With Previously Untreated Double-Positive DLBCL