Pixantrone-rituximab versus gemcitabine-rituximab in relapsed/refractory aggressive non-Hodgkin lymphoma
David Belada, Pencho Georgiev, Shaker Dakhil, Lowell F Inhorn, David Andorsky, J Thaddeus Beck, Donald Quick, Ruth Pettengell, Robert Daly, James P Dean, Mariya Pavlyuk, Nelly Failloux, Kai Hübel, David Belada, Pencho Georgiev, Shaker Dakhil, Lowell F Inhorn, David Andorsky, J Thaddeus Beck, Donald Quick, Ruth Pettengell, Robert Daly, James P Dean, Mariya Pavlyuk, Nelly Failloux, Kai Hübel
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.
Keywords: DLBCL; aggressive non-Hodgkin lymphoma; gemcitabine; pixantrone; relapse; rituximab.
Source: PubMed