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The HELIOS trial pr...
The HELIOS trial protocol: a phase III study of ibrutinib in combination with bendamustine and rituximab in relapsed/refractory chronic lymphocytic leukemia
- Artikel/kapitelEngelska2015
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LIBRIS-ID:oai:prod.swepub.kib.ki.se:130470007
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http://kipublications.ki.se/Default.aspx?queryparsed=id:130470007URI
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https://doi.org/10.2217/fon.14.119DOI
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Språk:engelska
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Sammanfattning på:engelska
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ABSTRACT Ibrutinib is an orally administered, covalent inhibitor of Bruton's tyrosine kinase with activity in B-cell malignancies based on Phase I/II studies. We describe the design and rationale for the Phase III HELIOS trial (trial registration: EudraCT No. 2012-000600-15; UTN No. U1111-1135-3745) investigating whether ibrutinib added to bendamustine and rituximab (BR) provides benefits over BR alone in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma. Eligible patients must have relapsed/refractory disease measurable on CT scan and meet ≥1 International Workshop on Chronic Lymphocytic Leukemia criterion for requiring treatment; patients with del(17p) are excluded. All patients receive BR (maximum six cycles) as background therapy and are randomized 1:1 to placebo or ibrutinib 420 mg/day. Treatment with ibrutinib or placebo will start concomitantly with BR and continue until disease progression or unacceptable toxicity. The primary end point is progression-free survival. Secondary end points include safety, objective response rate, overall survival, rate of minimal residual disease-negative remissions, and patient-reported outcomes. Tumor response will be assessed using the International Workshop on Chronic Lymphocytic Leukemia guidelines.
Biuppslag (personer, institutioner, konferenser, titlar ...)
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Kay, NE
(författare)
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Osterborg, AKarolinska Institutet
(författare)
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Chanan-Khan, AA
(författare)
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Mahler, M
(författare)
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Salman, M
(författare)
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Wan, Y
(författare)
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Sun, S
(författare)
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Zhuang, SH
(författare)
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Howes, A
(författare)
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Karolinska Institutet
(creator_code:org_t)
Sammanhörande titlar
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Ingår i:Future oncology (London, England): Future Medicine Ltd11:1, s. 51-591744-83011479-6694
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Hallek, M
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Kay, NE
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Osterborg, A
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Chanan-Khan, AA
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Mahler, M
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Salman, M
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visa fler...
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Wan, Y
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Sun, S
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Zhuang, SH
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Howes, A
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visa färre...
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Future oncology ...
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Karolinska Institutet