Phase II Study Comparing Celecoxib Plus R-CHOP Versus R-CHOP Alone for Newly Diagnosed Advanced CD5-Positive Diffuse Large B-Cell Lymphoma Randomized, Open-Label, Multicenter Trial

What this Trial Is About

Researchers are evaluating the effectiveness of adding celecoxib to the standard R-CHOP chemotherapy regimen compared to R-CHOP alone for treating newly diagnosed advanced CD5-positive diffuse large B-cell lymphoma CD5 DLBCL. This phase II, multicenter, randomized, double-blind study aims to determine the complete response rate CRR as the primary outcome to assess treatment efficacy. Participants are randomly assigned to receive either celecoxib combined with R-CHOP or R-CHOP alone. The R-CHOP regimen includes rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone administered in cycles every 21 days. Celecoxib is given orally twice daily from three days before to two days after each cycle. Treatment continues through six cycles. During the study, participants undergo tumor assessments at the end of cycles 2, 4, and 6 to measure response. Researchers monitor overall survival, event-free survival, progression-free survival, duration of response, and time to progression for up to two years. Safety is assessed by tracking adverse events during treatment and 30 days after the last dose. Follow-up visits occur approximately every four weeks for survival monitoring until study completion, lasting until May 2029.

Celecoxib Plus R-CHOP vs R-CHOP in Newly Diagnosed Advanced CD5+ DLBCL