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Current Oncology
Volume 22
Issue 4
10.3747/co.22.2431
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Article

An Open-Label Expanded-Access Trial of Bendamustine in Patients with Rituximab-Refractory Indolent Non-Hodgkin Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia: BEND-ACT

by
C.T. Kouroukis
1,*,
M. Crump
2,
D. MacDonald
3,
J.F. Larouche
4,
D.A. Stewart
5,
J. Johnston
6,
S. Sauvageau
7,
E. Beausoleil
7,
P. Sage
7,
S.G. Dubois
7,
A. Christofides
8,
S. Di Clemente
8 and
L. Sehn
9
1
Department of Oncology, McMaster University, and Juravinski Cancer Centre and Hospital, Hamilton, ON, Canada
2
Department of Medical Oncology and Hematology, University of Toronto, Toronto, ON, Canada
3
Dalhousie University and QEII Health Sciences Centre, Halifax, NS, Canada
4
Hematology–Oncology, CHU de Québec, Hôpital Enfant- Jésus, Montreal, QC, Canada
5
Department of Oncology and Medicine, University of Calgary, and Tom Baker Cancer Centre, Calgary, AB, Canada
6
Department of Internal Medicine, University of Manitoba, and Cancer Care Manitoba, Winnipeg, MB, Canada
7
Lundbeck Canada Inc., Montreal, QC, Canada
8
New Evidence, Toronto, ON, Canada
9
University of British Columbia and BC Cancer Agency, Vancouver, BC, Canada
*
Author to whom correspondence should be addressed.
Curr. Oncol. 2015, 22(4), 260-271; https://doi.org/10.3747/co.22.2431
Submission received: 4 May 2015 / Revised: 6 June 2015 / Accepted: 8 July 2015 / Published: 1 August 2015

Abstract

Background: Bendamustine is a bifunctional alkylating agent with unique properties that distinguish it from other agents in its class. Bendamustine is used as monotherapy or in combination with other agents to treat patients with non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Methods: The prospective interventional open-label BEND-ACT trial evaluated bendamustine in patients with rituximab-refractory indolent NHL (iNHL) and previously untreated CLL. Study objectives were to assess the safety and tolerability of bendamustine monotherapy and to provide patients with access to bendamustine before Health Canada approval. The study aimed to enrol up to 100 patients. All patients with iNHL received an intravenous dose of bendamustine 120 mg/m2 over 60 minutes on days 1 and 2 for up to eight 21- or 28-day treatment cycles. All patients with CLL received an intravenous dose of bendamustine 100 mg/m2 over 30 minutes on days 1 and 2 for up to six 28-day treatment cycles. Results: Of 90 patients treated on study (16 with CLL and 74 with iNHL), 35 completed the study (4 with CLL and 31 with iNHL). The most common treatment-emergent adverse events (TEAES) were nausea (70%), fatigue (57%), vomiting (40%), and diarrhea (33%)—mostly grades 1 and 2. Ondansetron was the most common supportive medication used in the patients (63.5% of those with iNHL and 68.8% of those with CLL). Neutropenia (32%), anemia (23%), and thrombocytopenia (21%) were the most frequent hematologic TEAES, with neutropenia being the most common grade 3 or 4 TEAES leading to dose modification. Dose delays occurred in 28 patients (31.3%) because of grade 3 or 4 TEAES, with a higher incidence of dose delays being observed in iNHL patients on the 21-day treatment cycle than in those on the 28-day treatment cycle (50.0% vs. 24.1%). During the study, 33 patients (36.7%) experienced at least 1 serious adverse event, and 4 deaths were reported (all in patients with iNHL). Conclusions: The type and frequency of the TEAES reported accorded with observations in earlier clinical trials and post-marketing experiences, thus confirming the acceptable and manageable safety profile of bendamustine.
Keywords: clinical trials; indolent non-Hodgkin lymphoma; chronic lymphocytic leukemia; bendamustine; open-label; expanded-access; safety clinical trials; indolent non-Hodgkin lymphoma; chronic lymphocytic leukemia; bendamustine; open-label; expanded-access; safety

Share and Cite

MDPI and ACS Style

Kouroukis, C.T.; Crump, M.; MacDonald, D.; Larouche, J.F.; Stewart, D.A.; Johnston, J.; Sauvageau, S.; Beausoleil, E.; Sage, P.; Dubois, S.G.; et al. An Open-Label Expanded-Access Trial of Bendamustine in Patients with Rituximab-Refractory Indolent Non-Hodgkin Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia: BEND-ACT. Curr. Oncol. 2015, 22, 260-271. https://doi.org/10.3747/co.22.2431

AMA Style

Kouroukis CT, Crump M, MacDonald D, Larouche JF, Stewart DA, Johnston J, Sauvageau S, Beausoleil E, Sage P, Dubois SG, et al. An Open-Label Expanded-Access Trial of Bendamustine in Patients with Rituximab-Refractory Indolent Non-Hodgkin Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia: BEND-ACT. Current Oncology. 2015; 22(4):260-271. https://doi.org/10.3747/co.22.2431

Chicago/Turabian Style

Kouroukis, C.T., M. Crump, D. MacDonald, J.F. Larouche, D.A. Stewart, J. Johnston, S. Sauvageau, E. Beausoleil, P. Sage, S.G. Dubois, and et al. 2015. "An Open-Label Expanded-Access Trial of Bendamustine in Patients with Rituximab-Refractory Indolent Non-Hodgkin Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia: BEND-ACT" Current Oncology 22, no. 4: 260-271. https://doi.org/10.3747/co.22.2431

APA Style

Kouroukis, C. T., Crump, M., MacDonald, D., Larouche, J. F., Stewart, D. A., Johnston, J., Sauvageau, S., Beausoleil, E., Sage, P., Dubois, S. G., Christofides, A., Di Clemente, S., & Sehn, L. (2015). An Open-Label Expanded-Access Trial of Bendamustine in Patients with Rituximab-Refractory Indolent Non-Hodgkin Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia: BEND-ACT. Current Oncology, 22(4), 260-271. https://doi.org/10.3747/co.22.2431

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