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Results of a Phase II trial of gemcitabine, mitoxantrone, and rituximab in relapsed or refractory mantle cell lymphoma.

Abstract：

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/m(2) IV (30-60 min infusion) on Days 1 and 8, mitoxantrone 10 mg/m(2) IV (5-10 min infusion) on day 1, and rituximab 375 mg/m(2) 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.

journal_name

Invest New Drugs

journal_title

Investigational new drugs

authors

Garbo LE,Flynn PJ,MacRae MA,Rauch MA,Wang Y,Kolibaba KS

doi

10.1007/s10637-008-9191-7

subject

Has Abstract

pub_date

2009-10-01 00:00:00

pages

476-81

issue

5

eissn

0167-6997

issn

1573-0646

journal_volume

27

pub_type

杂志文章,多中心研究

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