Phase IbII Trial of XNW5004 with CHOP or CHOEP Chemotherapy for Adults with Newly Diagnosed Peripheral T-Cell Lymphoma

What this Trial Is About

Researchers are evaluating the use of XNW5004 tablets combined with CHOP or CHOEP chemotherapy regimens for adults newly diagnosed with peripheral T-cell lymphoma PTCL, a type of non-Hodgkin lymphoma. This study is a Phase IbII trial aiming to determine the safety, tolerability, and recommended dose of XNW5004 in combination with these standard treatments, as well as to assess the treatments effectiveness over time. Participants will receive XNW5004 tablets at varying doses alongside either the CHOP or CHOEP regimen administered for six cycles. The study includes a dose escalation phase to find the optimal dosing for XNW5004 with each chemotherapy combination. After completing combination therapy and if the disease does not progress, participants will continue maintenance therapy with XNW5004 at 1200 mg twice daily. Throughout the study, participants will undergo regular assessments including monitoring for treatment-emergent adverse events, blood tests to measure drug levels, and evaluations of disease response such as objective response rate, disease control rate, and survival outcomes. The primary safety and effectiveness outcomes are tracked for up to three years, while pharmacokinetic and pharmacodynamic measures are monitored for about one year. The total study duration extends until September 2028.

Clinical Study of XNW5004 Combined With CHOP/CHOEP in the Treatment of Untreated Peripheral T-Cell Lymphoma