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
4th Department of Internal Medicine - Hematology, Charles University Hospital & Faculty of Medicine, Hradec Králové, Czech Republic.
UMHAT "Sveti Georgi", Plovdiv, Clinical Haematology Clinic, Plovdiv, Bulgaria.
Future Oncol. 2016 Aug;12(15):1759-68. doi: 10.2217/fon-2016-0137. Epub 2016 Apr 20.
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.
NCT01321541.
我们描述了一项正在进行的随机、活性对照、多中心III期研究的基本原理和设计，该研究旨在评估匹杉琼与利妥昔单抗联合用药对比吉西他滨与利妥昔单抗联合用药，用于治疗弥漫性大B细胞淋巴瘤或3级滤泡性淋巴瘤患者的疗效。这些患者不符合高剂量化疗和干细胞移植条件，且一线含利妥昔单抗的治疗方案失败。给药方案为：第1、8和15天静脉注射匹杉琼50mg/m²或吉西他滨1000mg/m²，并在第1天静脉注射利妥昔单抗375mg/m²，最多六个周期。匹杉琼在欧洲有条件获批用于单药治疗多次复发或难治性侵袭性B细胞非霍奇金淋巴瘤的成人患者。我们的试验探索了匹杉琼与利妥昔单抗联合用药的疗效，并完成上市后措施。
NCT01321541。
