A Multicenter, Prospective, Real-world Study of a Regimen Containing Tucidinostat for Primary Treatment of Diffuse Large B-cell Lymphoma

What this Trial Is About

Researchers are evaluating the clinical effectiveness and safety of tucidinostat in treating patients newly diagnosed with primary diffuse large B-cell lymphoma DLBCL. This observational, multicenter study involves 400 patients and aims to understand how tucidinostat works in real-world treatment settings. The study divides participants into two groups based on their fitness and ability to tolerate standard chemotherapy doses, focusing on those unfit due to age or comorbidities and those considered fit for conventional treatment. Participants receive treatment regimens that include tucidinostat combined with other therapies. The first group, considered unfit, may receive lower intensity treatment options such as C-R2 or C-R-mini-CHOP. The second group, considered fit, may be treated with conventional immunochemotherapy regimens like CR-CHOP or C-Pola-R-CHP. After induction therapy, patients who achieve complete response may enter consolidation therapy, which can include tucidinostat maintenance every three weeks for up to 24 weeks or autologous stem cell transplantation. During the study, participants will be monitored for treatment outcomes including two-year event-free survival as the primary measure. Secondary outcomes include complete response rate at the end of treatment, progression-free survival, and overall survival at two years. The study involves regular assessments to evaluate treatment effectiveness and safety, supporting a comprehensive understanding of tucidinostats role in managing DLBCL over the study period.

A Multicenter, Prospective, Real-world Study of a Regimen Containing Tucidinostat for Primary Treatment of DLBCL