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Wendtner, Clemens M., Hallek, Michael, Fraser, Graeme A. M., Michallet, Anne-Sophie, Hillmen, Peter, Durig, Jan, Kalaycio, Matt, Gribben, John G., Stilgenbauer, Stephan, Buhler, Andreas, Kipps, Thomas J., Purse, Brendan, Zhang, Jennie, De Bedout, Sabine, Mei, Jay and Chanan-Khan, Asher (2016). Safety and efficacy of different lenalidomide starting doses in patients with relapsed or refractory chronic lymphocytic leukemia: results of an international multicenter double-blinded randomized phase II trial*. Leuk. Lymphoma, 57 (6). S. 1291 - 1300. ABINGDON: TAYLOR & FRANCIS LTD. ISSN 1029-2403

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Abstract

The objective of this study was to evaluate the safety and efficacy of different lenalidomide starting doses in patients with relapsed/refractory chronic lymphocytic leukemia (CLL). CLL patients were randomized to receive lenalidomide at initial doses of 5, 10, or 15mg/d (N=103). Doses were escalated by 5mg every 28-d up to a maximum of 25mg/d; dose reductions in up to 5mg decrements were permitted. The most common grade3 adverse events (AEs) were neutropenia and thrombocytopenia. Ten patients died during therapy (four deaths considered as related to lenalidomide); 12 patients experienced second primary malignancies. The most common cause for treatment discontinuation was AEs. Overall response rates were similar across arms. Progression-free survival and overall survival rates were longer in patients who escalated treatment (to 15 or 20mg/d) versus those who did not. Lower starting doses allowed subsequent dose escalation of lenalidomide while maintaining an acceptable tolerability profile in patients with relapsed/refractory CLL.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Wendtner, Clemens M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hallek, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Fraser, Graeme A. M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Michallet, Anne-Sophie UNSPECIFIED UNSPECIFIED UNSPECIFIED Hillmen, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Durig, Jan UNSPECIFIED UNSPECIFIED UNSPECIFIED Kalaycio, Matt UNSPECIFIED UNSPECIFIED UNSPECIFIED Gribben, John G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Stilgenbauer, Stephan UNSPECIFIED UNSPECIFIED UNSPECIFIED Buhler, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Kipps, Thomas J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Purse, Brendan UNSPECIFIED UNSPECIFIED UNSPECIFIED Zhang, Jennie UNSPECIFIED UNSPECIFIED UNSPECIFIED De Bedout, Sabine UNSPECIFIED UNSPECIFIED UNSPECIFIED Mei, Jay UNSPECIFIED UNSPECIFIED UNSPECIFIED Chanan-Khan, Asher UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-275059
DOI:	10.3109/10428194.2015.1128540
Journal or Publication Title:	Leuk. Lymphoma
Volume:	57
Number:	6
Page Range:	S. 1291 - 1300
Date:	2016
Publisher:	TAYLOR & FRANCIS LTD
Place of Publication:	ABINGDON
ISSN:	1029-2403
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language SALVAGE THERAPY; CLL CELLS; RITUXIMAB; FLUDARABINE; BENDAMUSTINE; IDELALISIB Multiple languages Oncology; Hematology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/27505