LAUSR

ity or death. The overall response rate (ORR)was 64.3% including 23.8% CR, 4.7% unconfirmed CR (uCR) and 38% PR. The median overall survival (OS) and progression free survival (PFS) were 15 (95% CI = 8.645– 21.355) and 10 (CI 95% = 5.520–14.480) months, respectively. On the basis of these results and giving the lack of MTN‐CHT trials in lymphoma patients, the elderly commission of the FIL released in November 2016 the DEVEC trial (EUDRACT 2016‐003703‐62). Methods/Design: This is an open label, non‐randomized, multicentre, phase II study, to evaluate the efficacy and safety of DEVEC oral schedule (fig1) in large B‐cell (LBCL) and Burkitt lymphoma (BL) diagnosed in elderly unfit and frail patients who are R/R after previous treatment, and in super‐frail patients at disease onset. Patients will be enrolled according to Bryant & Day two‐stage optimal design.Co‐ Primary Objectives: 1) To explore the activity of the DEVEC induction + maintenance schedule; 2) To explore the safety of the DEVEC induction + maintenance schedule. Secondary Objectives: To evaluate the ORR (CR, Cru, PR) and the Clinical Benefit evaluated at the end of induction (EOI) cycles. OS, PFS, EFS, DFS, to assess QoL. Treatment Schedule: A) Induction phase: six courses (q 28 days) of PDN + ETO + VRN + CTX, ±RTX. Patients in PR and SD after 2 cycles will continue with additional 4 courses. At the end of the induction phase patients in ≥PR will continue treatment with B) Maintenance phase: six courses of PDN + VRN + CTX. (q28 days). Primary Endpoints: The primary efficacy endpoint is defined in terms of CRR (CR + Cru rate). The primary safety endpoint is defined as incidence, nature, and severity of adverse events.