Universität zu Köln

Goede, Valentin, Busch, Raymonde, Bahlo, Jasmin, Chataline, Viktoria, Kremers, Stephan, Mueller, Lothar, Reschke, Daniel, Schlag, Rudolf, Schmidt, Burkhard, Vehling-Kaiser, Ursula, Wedding, Ulrich, Stilgenbauer, Stefan and Hallek, Michael (2016). Low-dose fludarabine with or without darbepoetin alfa in patients with chronic lymphocytic leukemia and comorbidity: primary results of the CLL9 trial of the German CLL Study Group. Leuk. Lymphoma, 57 (3). S. 596 - 604. ABINGDON: TAYLOR & FRANCIS LTD. ISSN 1029-2403

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Abstract

This study was planned as a phase 3 trial to investigate low-dose fludarabine with or without darbepoetin alfa in older patients with previously untreated or treated chronic lymphocytic leukemia (CLL) and comorbidity. Due to slow recruitment, the study was terminated prematurely after accrual of 97 patients who, on average, were 74 years old and had a cumulative illness rating scale (CIRS) total score of 5. We report toxicity and efficacy of the study treatment. Grade 3-5 neutropenia and infection were observed in 25% and 10% of patients, respectively. Response was seen in 73% (5% complete remissions). Median event-free and overall survival was 12.2 and 44.8 months, respectively. No differences in outcome were found for patients treated with versus without darbepoetin alfa. In subjects with progressive/recurrent CLL during or after study treatment, overall survival was similar for patients receiving chemotherapy versus chemoimmunotherapy as salvage treatment.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Goede, Valentin UNSPECIFIED UNSPECIFIED UNSPECIFIED Busch, Raymonde UNSPECIFIED UNSPECIFIED UNSPECIFIED Bahlo, Jasmin UNSPECIFIED UNSPECIFIED UNSPECIFIED Chataline, Viktoria UNSPECIFIED UNSPECIFIED UNSPECIFIED Kremers, Stephan UNSPECIFIED UNSPECIFIED UNSPECIFIED Mueller, Lothar UNSPECIFIED UNSPECIFIED UNSPECIFIED Reschke, Daniel UNSPECIFIED UNSPECIFIED UNSPECIFIED Schlag, Rudolf UNSPECIFIED UNSPECIFIED UNSPECIFIED Schmidt, Burkhard UNSPECIFIED UNSPECIFIED UNSPECIFIED Vehling-Kaiser, Ursula UNSPECIFIED UNSPECIFIED UNSPECIFIED Wedding, Ulrich UNSPECIFIED UNSPECIFIED UNSPECIFIED Stilgenbauer, Stefan UNSPECIFIED UNSPECIFIED UNSPECIFIED Hallek, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-281733
DOI:	10.3109/10428194.2015.1079314
Journal or Publication Title:	Leuk. Lymphoma
Volume:	57
Number:	3
Page Range:	S. 596 - 604
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 ILLNESS RATING-SCALE; DOUBLE-BLIND; CANCER-PATIENTS; HEMATOLOGIC PARAMETERS; INTERNATIONAL-SOCIETY; CREATININE CLEARANCE; GERIATRIC ASSESSMENT; OPEN-LABEL; RITUXIMAB; CYCLOPHOSPHAMIDE Multiple languages Oncology; Hematology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/28173