PIX306 was a phase 3, randomised, single-blind, multicentre trial conducted in adult patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) grade 3 who relapsed after ≥1 rituximab-containing regimen and were not eligible for a stem cell transplant. Patients were randomised 1:1 to pixantrone 50 mg/m2 or gemcitabine 1000 mg/m2 on days 1, 8 and 15 of a 28-day cycle, combined with rituximab 375 mg/m2 on day 1, for up to six cycles. Patients were followed for up to 96 weeks. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), complete response (CR) rate, overall response rate (ORR) and safety. Overall, 312 patients were randomised (median age 73·0 years). The study did not meet its primary endpoint. Median PFS [95% confidence interval (CI)] was 7·3 months (5·2-8·4) with pixantrone + rituximab (PIX + R) and 6·3 months (4·4-8·1) with gemcitabine + rituximab [GEM + R; hazard ratio (HR): 0·85; 95% CI 0·64-1·14; P = 0·28]. Median OS was 13·3 (10·1-19·8) months with PIX + R and 19·6 (12·4-31·9) months with GEM + R (HR: 1·13; 95% CI 0·83-1·53). ORR was 61·9% and 43·9% respectively and CR rate 35·5% and 21·7%. The incidence of adverse events, including cardiac events, was not statistically significant different between PIX + R and GEM + R.

中文翻译：

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对于不适合干细胞移植的复发性侵袭性B细胞非霍奇金淋巴瘤复发患者，皮克蒽醌加利妥昔单抗与吉西他滨加利妥昔单抗：3期随机多中心试验（PIX306）。

PIX306是一项针对成人弥漫性大B细胞淋巴瘤（DLBCL）或滤泡性淋巴瘤（FL）3级的成人患者进行的3期随机，单盲，多中心试验，这些患者在接受≥1利妥昔单抗治疗后复发干细胞移植。在28天周期的第1、8和15天，患者按1：1比例接受pixantrone 50 mg / m2或吉西他滨1000 mg / m2，并在第1天与rituximab 375 mg / m2联合，最多进行6个周期。对患者进行了长达96周的随访。主要终点是无进展生存期（PFS）。次要终点包括总体生存率（OS），完全缓解率（CR），总体缓解率（ORR）和安全性。总共312例患者被随机分组​​（中位年龄73·0岁）。该研究未达到其主要终点。pixantrone + rituximab（PIX + R）的中位PFS [95％置信区间（CI）]为7·3个月（5·2-8·4），吉西他滨为6·3个月（4·4-8·1） +利妥昔单抗[GEM + R; 危险比（HR）：0·85；95％CI 0·64-1·14；P = 0·28]。使用PIX + R的OS中位数为13·3（10·1-19·8）个月，使用GEM + R的OS中位数为19·6（12·4-31·9）个月（HR：1·13; 95％CI 0· 83-1·53）。ORR分别为61·9％和43·9％，CR率分别为35·5％和21·7％。PIX + R和GEM + R之间的不良事件（包括心脏事件）的发生率在统计学上无显着差异。ORR分别为61·9％和43·9％，CR率分别为35·5％和21·7％。PIX + R和GEM + R之间的不良事件（包括心脏事件）的发生率在统计学上无显着差异。ORR分别为61·9％和43·9％，CR率分别为35·5％和21·7％。PIX + R和GEM + R之间的不良事件（包括心脏事件）的发生率在统计学上无显着差异。