TY - JOUR
T1 - Phase I/II study of bendamustine in combination with ofatumumab, carboplatin, etoposide (BOCE) for relapsed or refractory aggressive B-cell non-Hodgkin lymphoma
AU - Pan, Jonathan
AU - Ghimire, Sushil
AU - Alpdogan, S. Onder
AU - Chapman, Andrew
AU - Carabasi, Matthew
AU - DiMeglio, Martina
AU - Gong, Jerald
AU - Martinez-Outschoorn, Ubaldo
AU - Rose, Lewis
AU - Ramirez, Michael
AU - Wagner, John L.
AU - Weiss, Mark
AU - Flomenberg, Neal
AU - Pro, Barbara
AU - Porcu, Pierluigi
AU - Filicko-OHara, Joanne
AU - Gaballa, Sameh
N1 - Funding Information:
This was an open-label single-center phase I/II study combining escalating doses of bendamustine with fixed doses of ofatumumab, carboplatin, and etoposide in patients with RR B-cell NHL. The primary objectives were to assess the safety and tolerability of this outpatient regimen and determine the overall response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), duration of response (DoR), and proportion of patients who proceeded to SCT. The study was conducted in accordance with the Declaration of Helsinki and the protocol was approved by the institutional review board at Thomas Jefferson University Hospital. All participants signed informed written consent to be part of the trial. The trial was registered at clinicaltrials.gov (NCT01458366). Funding for the trial was provided by GlaxoSmithKline and Novartis, who supplied ofatumumab.
Funding Information:
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.
Funding Information:
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.
Publisher Copyright:
© 2020 Informa UK Limited, trading as Taylor & Francis Group.
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
KW - Relapsed/Refractory NHL
KW - bendamustine
KW - ofatumumab
UR - http://www.scopus.com/inward/record.url?scp=85095837265&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85095837265&partnerID=8YFLogxK
U2 - 10.1080/10428194.2020.1842400
DO - 10.1080/10428194.2020.1842400
M3 - Article
C2 - 33146052
AN - SCOPUS:85095837265
VL - 62
SP - 590
EP - 597
JO - Leukemia and Lymphoma
JF - Leukemia and Lymphoma
SN - 1042-8194
IS - 3
ER -