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【资讯翻译】A phase 1/1b study of rituximab, bendamustine, and ibrutini...

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发表于 2015-1-9 10:44:03 | 显示全部楼层 |阅读模式
A phase 1/1b study of rituximab, bendamustine, and ibrutinib in patients with untreated and relapsed/refractory non-Hodgkin lymphoma

Ibrutinib has single agent activity of 22% to 68% in relapsed B-cell non-Hodgkin lymphoma(NHL). This study evaluated the safety and efficacy of ibrutinib combined with rituximab (R) and bendamustine. Patients received R (375 mg/m2) on day 1, bendamustine (90 mg/m2) on days 1 and 2, and ibrutinib (280 or 560 mg) on days 1 to 28 every 28 days for 6 cycles followed by ibrutinib alone until progression. Forty-eight patients enrolled, including 12 patients with follicular lymphoma (FL), 16 with diffuse large B-cell lymphoma (DLCL), and 17 with mantle cell lymphoma (MCL). No dose-limiting toxicities were observed. Patients received a median of 8 cycles, with 26 completing 6 cycles and continuing ibrutinib alone in cycles 7 to 34. The overall response (OR) rate was 72%, with 52% complete responses (CRs). By histology, the OR rate was 94% (76% CR) in MCL, 37% (31% CR) in DLCL, and 90% (50% CR) in FL. Grade 3 to 4 toxicities included lymphopenia (77%), neutropenia (33%), thrombocytopenia (19%), and rash (25%). Median progression-free survival has not been reached (95% CI, 8.7 months to not reached). The recommended phase 2 dose of ibrutinib in combination with R-bendamustine in patients with NHL is 560 mg. The combination has promising efficacy, particularly in MCL and FL.


信源地址:http://www.bloodjournal.org/content/125/2/242

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发表于 2015-1-9 18:53:53 | 显示全部楼层
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发表于 2015-1-11 10:28:21 | 显示全部楼层
利妥昔单抗,苯达莫司汀以及依鲁替尼在未治愈,复发以及顽固性霍杰金淋巴瘤病人中的临床1/1b研究

依鲁替尼的单药活性在非霍杰金淋巴瘤淋巴瘤(NHL)中为22%~68%。该项研究评估了依鲁替尼联合利妥昔单抗以及苯达莫司汀治疗的安全性和有效性。病人在第一天服用利妥昔单抗(375mg/m(2)),在第一天和第二天服用苯达莫司汀(90 mg/m(2)),在第一天到第28天每天服用依鲁替尼,总共六个疗程后单独使用依鲁替尼直至好转。总共48位病人参与该项临床研究,这其中包括12位滤泡性淋巴瘤(FL)患者,16位弥漫性大B细胞淋巴瘤(DLCL)患者,以及17位套细胞淋巴瘤(MCL)患者。在研究过程中未发现剂量限制性毒性。所有病人平均接受了8个疗程的治疗,26个病人完成了6个疗程后继续单独使用依鲁替尼7到34个疗程。总体反应率为72%,其中完全反应率为52%。通过病理学观察,治疗反应率完全反应率在MCL中分别为94%和76%;在DLCL中分别为37%和31%;在FL中分别为90%和50%。3到4级毒性包括淋巴细胞减少(77%),嗜中性白细胞减少(33%),血小板减少(19%)以及皮疹(25%)。平均无进展生存期尚未达到(95% CI,8.7个月到未达到)。推荐的二期临床依鲁替尼联合苯达莫司汀治疗非霍杰金淋巴瘤的剂量为560mg。该项研究证明这项治疗方案在治疗MCL和FL中具有很好的有效性。

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 楼主| 发表于 2015-1-12 09:57:01 | 显示全部楼层
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