RT Journal Article T1 Lenalidomide plus R-GDP (R2-GDP) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: Final Results of the R2-GDP-GOTEL Trial and Immune Biomarker Subanalysis. A1 Palazon-Carrion, Natalia A1 Martin-Garcia-Sancho, Alejandro A1 Nogales-Fernandez, Esteban A1 Jimenez-Cortegana, Carlos A1 Carnicero-Gonzalez, Fernando A1 Rios-Herranz, Eduardo A1 de-la Cruz-Vicente, Fatima A1 Rodriguez-Garcia, Guillermo A1 Fernandez-Alvarez, Ruben A1 Martinez-Banaclocha, Natividad A1 Guma-Padro, Josep A1 Gomez-Codina, Jose A1 Salar-Silvestre, Antonio A1 Rodriguez-Abreu, Delvys A1 Galvez-Carvajal, Laura A1 Labrador, Jorge A1 Guirado-Risueño, Maria A1 Garcia-Dominguez, Daniel J A1 Hontecillas-Prieto, Lourdes A1 Espejo-Garcia, Pablo A1 Fernandez-Roman, Isabel A1 Provencio-Pulla, Mariano A1 Sanchez-Beato, Margarita A1 Navarro, Marta A1 Marylene, Lejeune A1 Alvaro-Naranjo, Tomas A1 Casanova-Espinosa, Maria A1 Sanchez-Margalet, Victor A1 Rueda-Dominguez, Antonio A1 de-la-Cruz-Merino, Luis K1 Recurrence K1 Drug Resistance, Neoplasm K1 Drug Therapy, Combination K1 Progression-Free Survival K1 Overall Survival K1 Tumor Biomarkers K1 Adverse Events AB New therapeutic options are needed in relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). Lenalidomide-based schedules can reverse rituximab refractoriness in lymphoma. In the phase II R2-GDP trial, 78 patients unsuitable for autologous stem cell transplant received treatment with the following schedule: lenalidomide 10 mg Days (D)1-14, rituximab 375 mg/m2 D1, cisplatin 60 mg/m2 D1, gemcitabine 750 mg/m2 D1 and D8, and dexamethasone 20 mg D1-3, up to 6 cycles (induction phase), followed by lenalidomide 10 mg (or last lenalidomide dose received) D1-21 every 28 days (maintenance phase). Primary endpoint was overall response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), safety, and monitorization of key circulating immune biomarkers (EU Clinical Trials Register number: EudraCT 2014-001620-29). After a median follow-up of 37 months, ORR was 60.2% [37.1% complete responses (CR) and 23.1% partial responses (PR)]. Median OS was 12 months (47 vs. 6 months in CR vs. no CR); median PFS was 9 months (34 vs. 5 months in CR vs. no CR). In the primary refractory population, ORR was 45.5% (21.2% CR and 24.3% PR). Most common grade 3-4 adverse events were thrombocytopenia (60.2%), neutropenia (60.2%), anemia (26.9%), infections (15.3%), and febrile neutropenia (14.1%). Complete responses were associated with a sharp decrease in circulating myeloid-derived suppressor cells and regulatory T cells. R2-GDP schedule is feasible and highly active in R/R DLBCL, including the primary refractory population. Immune biomarkers showed differences in responders versus progressors. PB American Association for Cancer Research YR 2022 FD 2022-09-01 LK http://hdl.handle.net/10668/20187 UL http://hdl.handle.net/10668/20187 LA en NO Palazón-Carrión N, Martín García-Sancho A, Nogales-Fernández E, Jiménez-Cortegana C, Carnicero-González F, Ríos-Herranz E, et al. Lenalidomide plus R-GDP (R2-GDP) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: Final Results of the R2-GDP-GOTEL Trial and Immune Biomarker Subanalysis. Clin Cancer Res. 2022 Sep 1;28(17):3658-3668. DS RISalud RD Oct 18, 2025