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 Subjects who do not achieve CR/CMR or PR/PMR in Stage 2 will be withdrawn from the study.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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Induction Phase (Chemotherapy-free): Serplulimab 300mg IV day 2 + Chidamide 30mg PO twice weekly (days 1,4,8,11,14,18) + Rituximab 375mg/m² IV day 1 per 21-day cycle for 2 cycles Consolidation Phase (Chemotherapy): R-CHOP regimen (Rituximab 375mg/m² + Cyclophosphamide 750mg/m² + Doxorubicin 50mg/m² + Vincristine 1.4mg/m² \[max 2mg\] IV day 1 + Prednisone 100mg PO days 1-5) per 21-day cycle for 4-6 cycles based on interim response Maintenance Phase: Serplulimab 300mg IV day 1 + Chidamide 30mg PO twice weekly (days 1,4,8,11,14,18) per 30-day cycle for 6 months
Sun Yat-sen University Cancer Center
Guangzhou, China
Objective Response Rate
Objective Response Rate (ORR) as Assessed per the LYRIC (Lugano Classification Modified for Response Evaluation in Lymphoma) 2016 Criteria.
Time frame: From start of treatment until disease progression or end of study, whichever occurs first, at the end of Cycle 8(each cycle is 21 days)
Complete Remission rate
Complete Remission rate as Assessed per the LYRIC (Lugano Classification Modified for Response Evaluation in Lymphoma) 2016 Criteria.
Time frame: From start of treatment until disease progression or end of study, whichever occurs first, at the end of Cycle 8(each cycle is 21 days)
Partial Remission Rate
Partial Remission Rate as Assessed per the LYRIC (Lugano Classification Modified for Response Evaluation in Lymphoma) 2016 Criteria.
Time frame: From start of treatment until disease progression or end of study, whichever occurs first, at the end of Cycle 8(each cycle is 21 days)
Progression Free Survival
Progression-Free Survival (PFS) is defined as the time (in months) from the first dose of the study drug until the first documented disease progression or death from any cause (whichever occurs first).
Time frame: From start of treatment until disease progression or end of study, whichever occurs first, up to 3 years)
Duration of Response
Duration of Response (DoR) is defined as the time from the initial documented response (CR or PR, whichever is recorded first) until the first documented disease progression or death from any cause.
Time frame: From the initial documented response(CR or PR, whichever is recorded first) until disease progression or end of study, whichever occurs first, up to 3 years)
Even free survival
Event-free Survival (EFS) is defined as the time from randomization/enrollment until the occurrence of any event, including death, disease progression, change in treatment regimen due to inadequate response or toxicity, or the onset of fatal or intolerab
Time frame: From start of treatment until death, disease progression, change in treatment regimen or end of study, whichever occurs first, up to 3 years
Overall survival
Overall Survival (OS) is defined as the time from the first dose of the study drug until death from any cause.
Time frame: From start of treatment until death or end of study, whichever occurs first, up to 3 years
Adverse Event
Frequency and severity of adverse events (AEs).
Time frame: From start of treatment until disease progression or end of study, whichever occurs first, up to 3 years)
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