Belada, D;
Georgiev, P;
Dakhil, S;
Inhorn, LF;
Andorsky, D;
Beck, JT;
Quick, D;
Pettengell, R;
Daly, R;
Dean, JP;
et al.
Belada, D; Georgiev, P; Dakhil, S; Inhorn, LF; Andorsky, D; Beck, JT; Quick, D; Pettengell, R; Daly, R; Dean, JP; Pavlyuk, M; Failloux, N; Hübel, K
(2016)
Pixantrone-rituximab versus gemcitabine-rituximab in relapsed/refractory aggressive non-Hodgkin lymphoma.
Future Oncology, 12 (15).
pp. 1759-1768.
ISSN 1744-8301
https://doi.org/10.2217/fon-2016-0137
SGUL Authors: Pettengell, Ruth
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Abstract
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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