Lenalidomide in combination with rituximab, dexamethasone, high-dose ARA-C and cisplatinum as salvage therapy in refractory or relapsed aggressive B-cell non-hodgkin-lymphoma - an open-label, multicentre phase I/II study (DSHNHL-R6).

Treatment of relapsed or refractory aggressive B-cell lymphoma (aNHL) is still an unmet medical need. Platinum-containing salvage immunotherapies achieve remission rates of 40-60%. The phase I/II DSHNHL-R6 trial sought to investigate feasibility, safety and efficacy of R-DHAP plus lenalidomide in patients with first or subsequent relapse of aNHL. 33 patients were enrolled in the trial and could be analyzed (ITT). Lenalidomide dose was stepwise increased if no dose-limiting toxicities were observed. Maximum tolerated dose (MTD) for lenalidomide in combination with R-DHAP was 15 mg administered on days 1-7 of each cycle. The overall response rates (ORR; defined as complete, unconfirmed complete or partial remission; using the revised response criteria by CT) and complete response rates (CR) rates were 60.6% and 27.3% for the ITT-population and 81.3% and 50.0% in the patients treated as per protocol (PP). With a median follow-up of 13.9 months, the median OS was 21.2 months and PFS for the ITT and PP-population were 10.7 and 18.9 months respectively. No treatment related deaths were observed. Haematologic adverse events (77% grade 3-4) were common. Combining Lenalidomide with R-DHAP is an effective salvage therapy for patients with aNHL. Prolonged use of lenalidomide lead to more toxicities. (registered at www.clinicaltrialsregister.eu ; EudraCT number: 2009-010824-25; Start Date: 2010-04-12).