Results of a Phase II trial of gemcitabine, mitoxantrone, and rituximab in relapsed or refractory mantle cell lymphoma
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Background: Gemcitabine (G) has shown activity in mantle cell lymphoma (MCL) as a single agent. The combination of mitoxantrone (M) and rituximab (R) is also active in MCL. The primary objective of this study was to determine the efficacy of G+M+R in relapsed or refractory MCL. Patients and Methods: Sixteen patients were enrolled between April 2005 and January 2007, 88% had Stage IV MCL, Median patient age was 74 years. Patients received gemcitabine 900 mg/m2 IV (30–60 min infusion) on Days 1 and 8, mitoxantrone 10 mg/m2 IV (5–10 min infusion) on day 1, and rituximab 375 mg/m2 IV on Day 1 (max 400 mg/hour) of the 21-day cycle. Patients received a median of 6 cycles (range, 1–8). Results: Best responses were CR 20% (95%CI, 0, 40.2), PR 27% (95%CI, 4.3, 49.1), SD 40% (95%CI, 15.2, 64.8), and PD 13% (95%CI, 0, 30.5). Median survival and PFS have not been reached with a median follow-up of 10.7 months. The most common Grade 3–4 toxicities were neutropenia (100%), thrombocytopenia (67%), leukopenia (53%), and anemia (33%). The study was closed early due to slow accrual owing to an alternative treatment which became available at the time. Conclusion: The combination of G+M+R in MCL was well-tolerated with manageable toxicity using growth factors to minimize neutropenia; further studies are warranted.
KeywordsMulticenter Community-based Lymphoma Phase II
We thank the patients who participated in this clinical trial, US Oncology physicians, the site coordinators, and data reviewers Denise Elmore-Lockheed, AA, Crystal Grant, BS, Tracy Locke, BS, Jessica Donato, MPH, for help with the statistical analysis, and Kristi A. Boehm, MS, and Maren K. Levin, MS, for editing and writing assistance. Research support was provided by Eli Lilly and Company, Indianapolis IN, USA.
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