Phase I/II study of bendamustine in combination with ofatumumab, carboplatin, etoposide (BOCE) for relapsed or refractory aggressive B-cell non-Hodgkin lymphoma

Abstract

We developed an outpatient salvage chemotherapy regimen using bendamustine, ofatumumab, carboplatin and etoposide (BOCE) to treat relapsed/refractory non-Hodgkin lymphoma (RR NHL) in a single-center phase I/II study. Primary objectives were safety, tolerability and overall response rate (ORR). Thirty-five RR NHL patients (57% de novo large cell [DLBCL] or grade 3B follicular [FL], 26% transformed DLBCL, 9% grade 3A FL, 3% mantle cell; median age = 62, median prior therapies = 1) were treated. Median follow-up was 24.1 months. ORR was 69% (CR = 49%, PR = 20% [ORR = 70%, CR = 50%, PR = 20% in the de novo DLBCL/grade 3B FL subgroup]). Median progression-free survival was 5.1 months and overall-survival 26.2 months. Twelve patients subsequently underwent stem cell transplantation. The most common non-hematologic grade 3–4 toxicities were neutropenic fever and hypophosphatemia. There were no treatment-related deaths. In conclusion, BOCE is a safe and effective outpatient salvage regimen for patients with RR NHL and serves as an effective bridge to stem cell transplantation.

Keywords:

• Relapsed/Refractory NHL
• bendamustine
• ofatumumab

Acknowledgments

A special thank you to the patients and their families who participated in the study. We would also like to acknowledge the Sidney Kimmel Cancer Center and Thomas Jefferson University Hospital for their support in this study. We would also like to thank GlaxoSmithKline and Novartis for providing trial funding. This work is dedicated to Dr. Elena Gitelson, a colleague and friend, who developed the original study prior to her untimely death.

Disclosure statement

Sameh Gaballa receives research funding from Genentech and Celgene and consults with Epizyme, Janssen, Celgene, and Pharmacyclics. Barbara Pro consults with Kyowa Hakka Kirin, Seattle Genetics, Takeda, and Celgene. Pierluigi Porcu receives research funding from Viracta, Innate Pharma, BeiGene, Incyte, Daiichi, Kyowa, ADCT, and consults with Spectrum.