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Pixantrone-rituximab versus gemcitabine-rituximab in relapsed/refractory aggressive non-Hodgkin lymphoma

D. Belada, P. Georgiev, S. Dakhil, LF. Inhorn, D. Andorsky, JT. Beck, D. Quick, R. Pettengell, R. Daly, JP. Dean, M. Pavlyuk, N. Failloux, K. Hübel,

. 2016 ; 12 (15) : 1759-68. [pub] 20160420

Language English Country England, Great Britain

Document type Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial

Persistent link   https://www.medvik.cz/link/bmc17013939
E-resources Online Full text

NLK PubMed Central from 2015 to 1 year ago
ProQuest Central from 2005-02-01 to 2020-12-31
Health & Medicine (ProQuest) from 2005-02-01 to 2020-12-31

Links

PubMed 27093976
DOI 10.2217/fon-2016-0137
Knihovny.cz E-resources

UNLABELLED: We describe the rationale and design of the ongoing randomized, active-controlled, multicenter, Phase III study evaluating the efficacy of pixantrone and rituximab versus gemcitabine and rituximab in patients with diffuse large B-cell lymphoma or follicular grade 3 lymphoma, who are ineligible for high-dose chemotherapy and stem cell transplantation, and who failed front-line regimens containing rituximab. The administration schedule is pixantrone 50 mg/m(2) intravenously (iv.) or gemcitabine 1000 mg/m(2) iv. on days 1, 8 and 15, combined with rituximab 375 mg/m(2) iv. on day 1, up to six cycles. Pixantrone has a conditional European marketing approval for monotherapy in adults with multiple relapsed or refractory aggressive B-cell non-Hodgkin lymphoma. Our trial explores the efficacy of combining pixantrone with rituximab and completes postauthorization measures. TRIAL REGISTRATION NUMBER: NCT01321541.

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