Langerbeins, Petra, Bahlo, Jasmin, Rhein, Christina, Cramer, Paula, Pflug, Natali, Fischer, Kirsten, Stilgenbauer, Stephan, Kreuzer, Karl Anton, Wendtner, Clemens-Martin, Eichhorst, Barbara and Hallek, Michael (2015). The CLL12 trial protocol: a placebo-controlled double-blind Phase III study of ibrutinib in the treatment of early-stage chronic lymphocytic leukemia patients with risk of early disease progression. Future Oncol., 11 (13). S. 1895 - 1904. LONDON: FUTURE MEDICINE LTD. ISSN 1744-8301

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Abstract

Observation (watch and wait) is the standard of care for patients with asymptomatic Binet stage A chronic lymphocytic leukemia (CLL). However, the clinical course of these patients is very heterogeneous with some patients requiring treatment rather soon and others not progressing for ages. The clinical staging does not reflect this high variability of the clinical course of CLL. Published data demonstrate that the comprehensive use of several risk factors dramatically improves the accuracy of prognostication independent of clinical stage. The treatment of CLL underwent considerable changes with the introduction of kinase-inhibitors, including ibrutinib, an orally administered, well-tolerated and potent inhibitor of Bruton's tyrosine kinase. This is the first prospective, multicenter, placebo-controlled, double-blind, Phase III study to compare efficacy and safety of ibrutinib to a watch-and-wait approach in Binet stage A CLL with risk of disease progression defined by the comprehensive CLL score.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Langerbeins, PetraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bahlo, JasminUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rhein, ChristinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cramer, PaulaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pflug, NataliUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fischer, KirstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stilgenbauer, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kreuzer, Karl AntonUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wendtner, Clemens-MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eichhorst, BarbaraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hallek, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-416312
DOI: 10.2217/FON.15.95
Journal or Publication Title: Future Oncol.
Volume: 11
Number: 13
Page Range: S. 1895 - 1904
Date: 2015
Publisher: FUTURE MEDICINE LTD
Place of Publication: LONDON
ISSN: 1744-8301
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
GENOMIC ABERRATIONS; SURVIVALMultiple languages
OncologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/41631

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