Hallek, Michael, Kay, Neil E., Osterborg, Anders, Chanan-Khan, Asher A., Mahler, Michelle, Salman, Mariya, Wan, Ying, Sun, Steven, Zhuang, Sen Hong and Howes, Angela (2015). The HELIOS trial protocol: a Phase III study of ibrutinib in combination with bendamustine and rituximab in relapsed/refractory chronic lymphocytic leukemia. Future Oncol., 11 (1). S. 51 - 60. LONDON: FUTURE MEDICINE LTD. ISSN 1744-8301
Full text not available from this repository.Abstract
Ibrutinib is an orally administered, covalent inhibitor of Bruton's tyrosine kinase with activity in B-cell malignancies based on PhaseI/II studies. We describe the design and rationale for the PhaseIII 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 420mg/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.
Item Type: | Journal Article | ||||||||||||||||||||||||||||||||||||||||||||
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URN: | urn:nbn:de:hbz:38-417717 | ||||||||||||||||||||||||||||||||||||||||||||
DOI: | 10.2217/fon.14.119 | ||||||||||||||||||||||||||||||||||||||||||||
Journal or Publication Title: | Future Oncol. | ||||||||||||||||||||||||||||||||||||||||||||
Volume: | 11 | ||||||||||||||||||||||||||||||||||||||||||||
Number: | 1 | ||||||||||||||||||||||||||||||||||||||||||||
Page Range: | S. 51 - 60 | ||||||||||||||||||||||||||||||||||||||||||||
Date: | 2015 | ||||||||||||||||||||||||||||||||||||||||||||
Publisher: | FUTURE MEDICINE LTD | ||||||||||||||||||||||||||||||||||||||||||||
Place of Publication: | LONDON | ||||||||||||||||||||||||||||||||||||||||||||
ISSN: | 1744-8301 | ||||||||||||||||||||||||||||||||||||||||||||
Language: | English | ||||||||||||||||||||||||||||||||||||||||||||
Faculty: | Unspecified | ||||||||||||||||||||||||||||||||||||||||||||
Divisions: | Unspecified | ||||||||||||||||||||||||||||||||||||||||||||
Subjects: | no entry | ||||||||||||||||||||||||||||||||||||||||||||
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URI: | http://kups.ub.uni-koeln.de/id/eprint/41771 |
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