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

被引:14
作者
Belada, David [1 ]
Georgiev, Pencho [2 ]
Dakhil, Shaker [3 ]
Inhorn, Lowell F. [4 ]
Andorsky, David [5 ]
Beck, J. Thaddeus [6 ]
Quick, Donald [7 ]
Pettengell, Ruth [8 ]
Daly, Robert [9 ]
Dean, James P. [9 ]
Pavlyuk, Mariya [10 ]
Failloux, Nelly [10 ]
Huebel, Kai [11 ]
机构
[1] Charles Univ Hosp & Fac Med, Dept Internal Med Hematol 4, Hradec Kralove, Czech Republic
[2] UMHAT Sveti Georgi, Clin Haematol Clin, Plovdiv, Bulgaria
[3] Canc Ctr Kansas, Wichita, KS USA
[4] Blue Ridge Canc Care, Roanoke, VA USA
[5] Rocky Mt Canc Ctr, Boulder, CO USA
[6] Highlands Oncol Grp, Fayetteville, AR USA
[7] Joe Arrington Canc Res & Treatment Ctr, Lubbock, TX USA
[8] St Georges Healthcare NHS Trust, London, England
[9] CTI Biopharma Corp, Seattle, WA USA
[10] Inst Rech Int Servier, Suresnes, France
[11] Univ Hosp Cologne, Cologne, Germany
关键词
aggressive non-Hodgkin lymphoma; DLBCL; gemcitabine; pixantrone; relapse; rituximab; B-CELL LYMPHOMA; MULTICENTER PHASE-II; SINGLE-AGENT; MALIGNANT-LYMPHOMA; ADULT PATIENTS; REGIMENS; TRIAL; DRUG; CHOP;
D O I
10.2217/fon-2016-0137
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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.
引用
收藏
页码:1759 / 1768
页数:10
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