Study of Orelabrutinib Combined with R-CHOP as First Treatment for CD5-Positive Diffuse Large B-Cell Lymphoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining orelabrutinib with the standard R-CHOP chemotherapy regimen as a first treatment for patients with CD5-positive diffuse large B-cell lymphoma DLBCL. This phase II, multicenter trial focuses on patients who have not received prior treatment. The study aims to understand if adding orelabrutinib improves patient outcomes compared to historical data. Participants will receive up to 8 cycles of treatment over several months. The first cycle uses R-CHOP alone, with orelabrutinib tablets 150 mg daily added starting from the second cycle. After 6 cycles of combination therapy, patients receive 2 more cycles of rituximab plus orelabrutinib. If a complete remission is achieved after these 8 cycles, patients will continue taking orelabrutinib as maintenance therapy. During the study, researchers will monitor participants closely with assessments to track disease progression, response to treatment, and side effects. They will measure outcomes such as event-free survival over 2 years, complete response rate, disease-free survival, and overall survival. Safety will be evaluated by recording adverse events throughout the study. The total participation period may last around 2 years, including follow-up to assess long-term effects.

Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients（Rocket Trial）