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小木虫论坛-学术科研互动平台 » 生物医药区 » 新药研发 » 临床研究 » 求Ibrutinib 一个Ⅲ期临床试验和试验数据、结果
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kdl0721

金虫 (著名写手)
引用回帖:
10楼: Originally posted by xiaoerduomao at 2014-04-09 09:50:28
这个3期临床还没结束呢，按照你给的是ongoing，并不是completed
http://scimore.asia:1080/pharmallPluswebsite/database/tpharma/cortallis/ibrutinib001755.htm

谢谢，这个三期临床试验由于结果呈显著阳性已经被FDA审查机构统一结束了，数据还没有公布，可能要到2014年ASCO年会上。你这个是汤森路透的数据？
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11楼2014-04-09 11:13:19
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xiaoerduomao

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引用回帖:
11楼: Originally posted by kdl0721 at 2014-04-09 11:13:19
谢谢，这个三期临床试验由于结果呈显著阳性已经被FDA审查机构统一结束了，数据还没有公布，可能要到2014年ASCO年会上。你这个是汤森路透的数据？...

是的
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12楼2014-04-09 11:36:52
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dengchun14
13楼2014-04-09 11:43:16
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kdl0721

金虫 (著名写手)
看来都没有知道该临床试验具体数据的，只能等2014ASCO年会了。
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14楼2014-04-09 13:36:44
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kdl0721

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引用回帖:
12楼: Originally posted by xiaoerduomao at 2014-04-09 11:36:52
是的...

能给我发一份最新完整版的汤森路透报告吗？谢谢，金币都给你。
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15楼2014-04-09 13:39:23
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kdl0721

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版主，请关闭该求助帖子，我已得到结果，谢谢！
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16楼2014-06-06 10:38:12
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tsenghw

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【答案】应助回帖

N Engl J Med. 2014 Jul 17;371(3):213-23. doi: 10.1056/NEJMoa1400376. Epub 2014 May 31.
Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia.
Byrd JC, Brown JR, O'Brien S, Barrientos JC, Kay NE, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U, Devereux S, Barr PM, Furman RR, Kipps TJ, Cymbalista F, Pocock C, Thornton P, Caligaris-Cappio F, Robak T, Delgado J, Schuster SJ, Montillo M, Schuh A, de Vos S, Gill D, Bloor A, Dearden C, Moreno C, Jones JJ, Chu AD, Fardis M, McGreivy J, Clow F, James DF, Hillmen P; RESONATE Investigators.
Collaborators (67)

Abstract
BACKGROUND:
In patients with chronic lymphoid leukemia (CLL) or small lymphocytic lymphoma (SLL), a short duration of response to therapy or adverse cytogenetic abnormalities are associated with a poor outcome. We evaluated the efficacy of ibrutinib, a covalent inhibitor of Bruton's tyrosine kinase, in patients at risk for a poor outcome.

METHODS:
In this multicenter, open-label, phase 3 study, we randomly assigned 391 patients with relapsed or refractory CLL or SLL to receive daily ibrutinib or the anti-CD20 antibody ofatumumab. The primary end point was the duration of progression-free survival, with the duration of overall survival and the overall response rate as secondary end points.

RESULTS:
At a median follow-up of 9.4 months, ibrutinib significantly improved progression-free survival; the median duration was not reached in the ibrutinib group (with a rate of progression-free survival of 88% at 6 months), as compared with a median of 8.1 months in the ofatumumab group (hazard ratio for progression or death in the ibrutinib group, 0.22; P<0.001). Ibrutinib also significantly improved overall survival (hazard ratio for death, 0.43; P=0.005). At 12 months, the overall survival rate was 90% in the ibrutinib group and 81% in the ofatumumab group. The overall response rate was significantly higher in the ibrutinib group than in the ofatumumab group (42.6% vs. 4.1%, P<0.001). An additional 20% of ibrutinib-treated patients had a partial response with lymphocytosis. Similar effects were observed regardless of whether patients had a chromosome 17p13.1 deletion or resistance to purine analogues. The most frequent nonhematologic adverse events were diarrhea, fatigue, pyrexia, and nausea in the ibrutinib group and fatigue, infusion-related reactions, and cough in the ofatumumab group.

CONCLUSIONS:
Ibrutinib, as compared with ofatumumab, significantly improved progression-free survival, overall survival, and response rate among patients with previously treated CLL or SLL. (Funded by Pharmacyclics and Janssen; RESONATE ClinicalTrials.gov number, NCT01578707.).
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17楼2015-11-11 22:17:53
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