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

Leuk Lymphoma. 2021 Mar;62(3):590-597. doi: 10.1080/10428194.2020.1842400. Epub 2020 Nov 4.

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.

Publication types

  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Combined Chemotherapy Protocols* / adverse effects
  • B-Lymphocytes
  • Bendamustine Hydrochloride / therapeutic use
  • Carboplatin / adverse effects
  • Etoposide / adverse effects
  • Humans
  • Lymphoma, Non-Hodgkin* / drug therapy
  • Middle Aged
  • Neoplasm Recurrence, Local / drug therapy
  • Salvage Therapy

Substances

  • Antibodies, Monoclonal, Humanized
  • Etoposide
  • Bendamustine Hydrochloride
  • Carboplatin
  • ofatumumab