LEGEND: A randomised phase II study comparing lenalidomide plus rituximab, gemcitabine, and methylprednisolone (R-GEM-L) to rituximab, gemcitabine, methylprednisolone, and cisplatin (R-GEM-P) in second-line treatment of diffuse large B-cell lymphoma (DLBCL).

TPS8618 Background: Diffuse Large B-cell lymphoma (DLBCL) exhibits high sensitivity to first-line chemo-immunotherapy, however approximately one-third of patients (pts) will relapse. A number of salvage regimens including R-GEM-P (rituximab, gemcitabine, cisplatin and methylprednisolone), are used in the relapsed/refractory (RR) setting, with overall (OR) and complete (CR) response rates of 50-70% and 20-50% respectively. Pts eligible for post-salvage consolidation with autologous stem cell transplantation (ASCT) have an overall survival (OS) of 40% at 3 years, while ASCT-ineligible pts have a very poor prognosis. More efficacious salvage regimens are urgently needed for this patient group. Lenalidomide has shown activity in RR DLBCL (both as monotherapy and in combination with rituximab), and has been safely combined with gemcitabine in pancreatic cancer. In the LEGEND trial R-GEM-L (rituximab 375mg/m2 D1 and 15, gemcitabine 1000mg/m2 D1, 8 and 15, methylprednisolone 1000mg D1-5 and lenalidomide 25mg od ...