R-CMOP in Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma

This is an open, multicenter, prospective phase I/II clinical study to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome injection in combination with cyclophosphamide, vincristine, prednisone, and rituximab (R-CMOP) in patients with newly diagnosed diffuse large B-cell lymphoma. The study is divided into two parts. The first part uses a 3+3 dose-escalation design, in which mitoxantrone hydrochloride liposome injection in the R-CMOP regimen will be administered at three different doses: 16 mg/m², 18 mg/m², and 20 mg/m², to determine the recommended Phase 2 dose (RP2D). The second part follows a single-arm design to evaluate the efficacy and safety of the R-CMOP regimen, with mitoxantrone hydrochloride liposome injection administered at the RP2D. Each cycle consists of 21 days. A maximum of 6 cycles of therapy are planned.