Serplulimab, Chidamide, and Rituximab Followed by Sequential R-CHOP for Newly Diagnosed Elderly MYC/BCL2 Double-Expressor DLBCL
Summary
NIH ClinicalTrials.gov registered a Phase 2 clinical trial (NCT07538180) evaluating a three-stage treatment protocol for newly diagnosed elderly patients with MYC/BCL2 double-expressor DLBCL. The protocol consists of chemotherapy-free SCR therapy (Serplulimab, Chidamide, Rituximab), followed by R-CHOP chemotherapy, then maintenance therapy. The trial enrolls elderly patients and allows R-miniCHOP for frail patients over 75 years.
What changed
This document registers a Phase 2 clinical trial with ClinicalTrials.gov describing a three-stage treatment protocol for elderly patients with newly diagnosed MYC/BCL2 double-expressor DLBCL. The trial uses serplulimab, chidamide, and rituximab in a chemotherapy-free first stage, followed by R-CHOP or R-miniCHOP in the second stage, with maintenance therapy in stage three.
Healthcare institutions and oncology researchers may encounter this trial as a reference for emerging DLBCL treatment approaches. Sponsors considering similar lymphoma trials should ensure registration compliance with ClinicalTrials.gov requirements. The trial represents an investigational protocol and does not establish standard-of-care guidance.
Archived snapshot
Apr 20, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Serplulimab, Chidamide, and Rituximab Followed by Sequential R-CHOP for Newly Diagnosed Elderly MYC/BCL2 Double-Expressor DLBCL
Phase 2 NCT07538180 Kind: PHASE2 Apr 20, 2026
Abstract
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 serp...
Conditions: Newly Diagnosed MYC/BCL2 Double-expressor DLBCL
Interventions: SCR Regimen Sequential with R-CHOP and Maintenance Therapy
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