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Updated: Feb 10, 2026
Enumeration of Major Peripheral Blood Leukocyte Populations for Multicenter Clinical Trials Using a Whole Blood Phenotyping Assay
Published on: September 16, 2012
Penpulimab in combination with lenalidomide and R-GemOx regimen (R2-GemOx-PD1i) in relapsed or refractory diffuse
Jin-Hua Liang1, Tong-Yao Xing1, Wei-Ying Gu2
1Department of Hematology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, 210029, China.
Background:
This phase II clinical trial evaluated the R2-GemOx-PD1i regimen, a combination of penpulimab (a modified PD1 inhibitor) with lenalidomide and rituximab, gemcitabine, and oxaliplatin, in treating refractory or relapsed (R/R) diffuse large B-cell lymphoma (DLBCL).
Methods:
Patients received an induction treatment of up to six cycles of R2-GemOx-PD-1i at standard doses every 2 weeks, followed by pembrolizumab and lenalidomide as maintenance or autologous stem cell transplantation (ASCT) as consolidation. The primary objective was to evaluate the complete response rate (CRR) after the induction phase.
Results:
Fifty-four patients were included, including subgroups treated without intent for consolidation with ASCT (N = 38) and those utilizing R2-GemOx-PD1i as a bridge to ASCT (N = 16). The overall response rate (ORR) for all patients was 66.7%, with a CRR of 57.4%. The median progression-free survival (PFS) was 30.4 months, and the median overall survival (OS) was not reached for all patients. Patients receiving R2-GemOx-PD1i without intent for ASCT had ORR and CRR of 63.2% and 52.6%, respectively, with median PFS and OS of 21.2 months and not reached, respectively. Patients receiving R2-GemOx-PD1i as a bridge to ASCT had ORR and CRR of 75.0% and 68.8%, respectively, with median PFS and OS of both not reached, respectively. The most frequent treatment-related adverse events were neutropenia (36, 66.6%) and anemia (32, 59.2%). Hypothyroidism was the most common immune-related adverse event (20 [37.0%]).
Conclusion:
The R2-GemOx-PD1i regimen demonstrated encouraging antitumor activity with manageable toxicity in R/R DLBCL, providing some reassurance about its safety and tolerability.
Trial Registration:
ClinicalTrials.gov, NCT05186558 (Dec 23, 2021).
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