Chidamide Plus R-CHOP Treatment for Newly Diagnosed Double-Expressor Diffuse Large B-Cell Lymphoma with Other Molecular Subtypes A Phase II Multicenter Study

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a treatment combining chidamide with R-CHOP chemotherapy in patients newly diagnosed with double-expressor diffuse large B-cell lymphoma DEL-DLBCL of the Other molecular subtype. This subtype has been linked to poorer survival outcomes, and previous trials suggested that chidamide plus R-CHOP might improve response rates and event-free survival in DEL patients. This study is a phase II trial aiming to confirm these findings specifically in patients with the Other molecular subtype of DEL-DLBCL. The treatment being studied is a combination of chidamide and R-CHOP, which includes rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone. Participants will receive this combined therapy as their initial treatment. The study involves up to six cycles of treatment, each lasting 21 days. This approach is designed to assess the complete response rate and other outcomes over the course of treatment. Participants will be closely monitored throughout the study, which includes evaluations through imaging tests like CT or MRI to measure tumor lesions. Researchers will track progression-free survival over two years as the main outcome. Additional assessments include overall survival and objective response rate up to six treatment cycles. Safety, liver and kidney function, and patient consent will be carefully observed. The total study duration and follow-up extend to at least two years to evaluate long-term treatment effects and patient outcomes.

Chidamide Plus R-CHOP in Newly Diagnosed Double-Expressor Diffuse Large B-Cell Lymphoma With Other Molecular Subtypes