A phase III open label randomized study to compare the efficacy of lenalidomide-rituximab vs bendamustine-rituximab in treatment naive follicular lymphoma.

e19552 Background: Bendamustine-rituximab (BR) is the preferred regimen for treatment naïve follicular lymphoma (FL).Lenalidomide-rituximab (LR), a chemotherapy-free protocol has shown good response rate in advanced FLin phase II trials. These regimens have never been compared head to head in a randomized controlled trial for treatment naïve FL. Methods: This phase III open label randomised controlled trial was conducted at our center from January 2016 to December 2017.Treatment naïve patients with age more than 18 years, ECOG PS ≤2, who were diagnosed with FL (Stage II–IV)were included in our study.Patients were randomised in 1:1 ratio to receive six cycles of BR(bendamustine 90 mg/m2 d1-2 and rituximab 375mg/m2 d1) every 4 weeks or LR (lenalidomide 20 mg d1-21 and rituximab 375 mg/m2) every 4 weeks.The primary endpoint was complete response rate (CRR)and secondary endpoints were overall response rate(ORR) and toxicity. The trial is registered with Clinical Trials Registry-India (CTRI/2016/05/006904). Results: We enrolled 23 patients, 11patients received BR and 12 patients received LR. At a median follow up of 15 months, theCRRwas 63.6 %( n = 7) and 16.6% ( n = 2) in BR and LR arm respectively (p = 0.03). The ORR was 81.8% (n = 9) and 83.3 %( n = 10) in BR and LR arm respectively (p = 1.0). BR was better tolerated than LR with lower rates of all grade of toxicities (54% vs 92%),anemia (0% vs 33.3%), skin toxicity (18% vs 33%), diarrhoea (18% vs 42%), vomiting(9% vs 25%)and nephrotoxicity (0% vs 17%). There was no significant difference in grade 3 or 4 toxicities between BR and LR arm (27% vs 25%). Conclusions: The ORR was similar in both the arms, however, CRR were significantly higher with BR arm. BR was better tolerated than LR. Clinical trial information: CTRI/2016/05/006904.