Universität zu Köln

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
Creators:	Creators Email ORCID ORCID Put Code Hallek, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Kay, Neil E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Osterborg, Anders UNSPECIFIED UNSPECIFIED UNSPECIFIED Chanan-Khan, Asher A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mahler, Michelle UNSPECIFIED UNSPECIFIED UNSPECIFIED Salman, Mariya UNSPECIFIED UNSPECIFIED UNSPECIFIED Wan, Ying UNSPECIFIED UNSPECIFIED UNSPECIFIED Sun, Steven UNSPECIFIED UNSPECIFIED UNSPECIFIED Zhuang, Sen Hong UNSPECIFIED UNSPECIFIED UNSPECIFIED Howes, Angela UNSPECIFIED UNSPECIFIED UNSPECIFIED
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
Uncontrolled Keywords:	Keywords Language B-CELL RECEPTOR; THERAPY; FLUDARABINE; ACTIVATION; BTK Multiple languages Oncology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/41771