Pixantrone–rituximab versus gemcitabine–rituximab in relapsed/refractory aggressive non-Hodgkin lymphoma. (August 2016)

• Record Type: Journal Article
• Authors: Belada, David; Georgiev, Pencho; Dakhil, Shaker; Inhorn, Lowell F; Andorsky, David; Beck, J Thaddeus; Quick, Donald; Pettengell, Ruth; Daly, Robert; Dean, James P; Pavlyuk, Mariya; Failloux, Nelly; Hübel, Kai
• Is Part Of: Future oncology. Volume 12:Number 15(2016)
• Page Start: 1759
• Page End: 1768
• Publication Date: 2016-08
• Subjects: aggressive non-Hodgkin lymphoma -- DLBCL -- gemcitabine -- pixantrone -- relapse -- rituximab; Oncology -- Periodicals; 616.99405
• DOI: 10.2217/fon-2016-0137
• Languages: English
• ISSNs: 1479-6694

Abstract

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.