Serplulimab, Chidamide, and Rituximab Followed by Sequential R-CHOP for Newly Diagnosed Elderly MYC/BCL2 Double-Expressor DLBCL

Summary

This study is a phase II clinical trial and is divided into three stages. Stage 1: Chemotherapy-free phase. All subjects will receive "Serplulimab, Chidamide, and Rituximab (SCR) therapy". After 2 treatment cycles, efficacy will be evaluated. Subjects who achieve CR or CMR will continue to receive 2 additional cycles of SCR therapy. Patients who do not achieve CR or CMR will proceed to Stage 2 treatment. The SCR regimen consists of rituximab 375mg/m² IV on day 1, serplulimab 300mg IV on day 2, and chidamide 30mg PO twice weekly (on days 1, 4, 8, 11, 14, and 18), repeated every 21 days. Stage 2: Chemotherapy Phase. Subjects who achieved CR or CMR in Stage 1 will receive 4 cycles of R-CHOP therapy, while those who did not achieve CR or CMR will receive 6 cycles of R-CHOP therapy. Patients at high risk for central nervous system (CNS) involvement will receive consensus-recommended CNS prophylactic therapy (e.g., high-dose methotrexate). The R-CHOP regimen is administered at the following dosages: rituximab 375mg/m², cyclophosphamide 750mg/m², doxorubicin 50mg/m², all administered intravenously on day 1; vincristine 1.4mg/m² (max 2mg) intravenously on day 1; and prednisone 100mg orally on days 1-5. The treatment cycle is repeated every 21 days. For patients over 75 years of age or those considered frail, the R-miniCHOP regimen may be utilized. Stage 3: Maintenance Therapy. Subjects who achieve CR/CMR or PR/PMR in Stage 2 will proceed to the maintenance phase, receiving serplulimab in combination with chidamide for 6 months. Subjects who do not achieve CR/CMR or PR/PMR in Stage 2 will be withdrawn from the study. During the maintenance phase, the regimen consists of serplulimab 300mg administered intravenously on day 1 and chidamide 30mg administered orally twice per week (specifically on days 1, 4, 8, 11, 14, and 18) of a 30-day cycle.

Timeline

Start

2025-10-30

Primary completion

2027-12-31

Completion

2028-12-31

Drugs

Indications