Originally published as JCO Early Release 10.1200/JCO.2008.17.0001 on July 14 2008

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Phase II Multicenter Study of Bendamustine Plus Rituximab in Patients With Relapsed Indolent B-Cell and Mantle Cell Non-Hodgkin's Lymphoma

K. Sue Robinson, Michael E. Williams, Richard H. van der Jagt, Philip Cohen, Jordan A. Herst, Anil Tulpule, Lee S. Schwartzberg, Bernard Lemieux, Bruce D. Cheson

From the QE II Health Sciences Centre, Halifax, Nova Scotia; Ottawa General Hospital, Ottawa; Northeastern Ontario Regional Cancer Centre, Sudbury, Ontario; Hospital Notre-Dame Du Chum, Montreal, Quebec, Canada; University of Virginia Health System, Charlottesville, VA; Georgetown University Hospital, Washington, DC; University of Southern California/Norris Cancer Hospital, Los Angeles, CA; and West Cancer Clinic, Memphis, TN

Corresponding author: Bruce D. Cheson, MD, Georgetown University Hospital, 3800 Reservoir Rd, NW, Washington, DC 20007-2197; e-mail: bdc4{at}georgetown.edu

Purpose Bendamustine HCl is a bifunctional mechlorethamine derivative with clinical activity in the treatment of non-Hodgkin's lymphoma. This study evaluated bendamustine plus rituximab in 67 adults with relapsed, indolent B-cell or mantle cell lymphoma without documented resistance to prior rituximab.

Patients and Methods Patients received rituximab 375 mg/m² intravenously on day 1 and bendamustine 90 mg/m² intravenously on days 2 and 3 of each 28-day cycle for four to six cycles. An additional dose of rituximab was administered 1 week before the first cycle and 4 weeks after the last cycle. Sixty-six patients (median age, 60 years) received at least one dose of both drugs.

Results Overall response rate was 92% (41% complete response, 14% unconfirmed complete response, and 38% partial response). Median duration of response was 21 months (95% CI, 18 to 24 months). Median progression-free survival time was 23 months (95% CI, 20 to 26 months). Outcomes were similar for patients with indolent or mantle cell histologies. The combination was generally well tolerated; the primary toxicity was myelosuppression (grade 3 or 4 neutropenia, 36%; grade 3 or 4 thrombocytopenia, 9%).

Conclusion Bendamustine plus rituximab is an active combination in patients with relapsed indolent and mantle cell lymphoma.

published online ahead of print at www.jco.org on July 14, 2008.

Supported by Cephalon, Inc.

Preliminary results were presented at the 48th Annual Meeting of the American Society of Hematology, December 9-12, 2006, Orlando, FL.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical trial information can be found for the following: NCT00069758 [ClinicalTrials.gov] .

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