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.

Large B cell lymphoma is recognized as a heterogeneous disease those relapse may occur in up to 30-40% of the patients. Therefore, relapsed/refractory diffuse large B cell lymphoma (R/R DLBCL) represent a big clinical challenge. We conducted an academic open label multicenter phase 2 trial (R2-GDP-GOTEL) testing the synergism of combination of LEN and rituximab (R2) plus gemcitabine, cisplatin, dexamethasone (R2-GDP schedule) in R/R DLBCL pts, not suitable for autologous stem cell transplantation (ASCT). Results suggest that LEN in combination with R-GDP (R2-GDP schedule) is an immunomodulatory treatment option with manageable toxicity and promising clinical activity, with high proportion of complete responses and favorable survival outcomes in pts with R/R DLBCL who are ineligible for ASCT. Additionally, we propose to evolution of MDSC and Treg in peripheral blood as an alternative for monitoring immune profiling that is clearly related to clinical outcomes in terms of overall survival and complete responses.