Universität zu Köln

Cartron, Guillaume ORCID: 0000-0003-0659-9635, de Guibert, Sophie, Dilhuydy, Marie-Sarah, Morschhauser, Franck, Leblond, Veronique, Dupuis, Jehan, Mahe, Beatrice, Bouabdallah, Reda, Lei, Guiyuan, Wenger, Michael, Wassner-Fritsch, Elisabeth and Hallek, Michael (2014). Obinutuzumab (GA101) in relapsed/refractory chronic lymphocytic leukemia: final data from the phase 1/2 GAUGUIN study. Blood, 124 (14). S. 2196 - 2203. WASHINGTON: AMER SOC HEMATOLOGY. ISSN 1528-0020

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Abstract

GAUGUIN evaluated the safety and efficacy of obinutuzumab (GA101) monotherapy in patients with relapsed/refractory chronic lymphocytic leukemia (CLL). In phase 1 (dose escalation), 13 patients received obinutuzumab 400 to 1200 mg (days 1 and 8 of cycle 1; day 1 of cycles 2-8). In phase 2, 20 patients received a fixed dose of 1000 mg (days 1, 8, and 15 of cycle 1; day 1 of cycles 2-8). Infusion-related reactions occurred in nearly all patients, but few were grade 3/4. Grade 3/4 neutropenia occurred in 7 patients in phase 1 (but was not dose-related) and in 4 patients in phase 2. Overall end-of-treatment response (all partial responses) was 62% (phase 1) and 15% (phase 2); best overall response was 62% and 30%, respectively. Phase 2 median progression-free survival was 10.7 months and median duration of response was 8.9 months. In summary, obinutuzumab monotherapy is active in patients with heavily pretreated relapsed/refractory CLL. GAUGUIN was registered at www.clinicaltrials.gov as #NCT00517530.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Cartron, Guillaume UNSPECIFIED orcid.org/0000-0003-0659-9635 UNSPECIFIED de Guibert, Sophie UNSPECIFIED UNSPECIFIED UNSPECIFIED Dilhuydy, Marie-Sarah UNSPECIFIED UNSPECIFIED UNSPECIFIED Morschhauser, Franck UNSPECIFIED UNSPECIFIED UNSPECIFIED Leblond, Veronique UNSPECIFIED UNSPECIFIED UNSPECIFIED Dupuis, Jehan UNSPECIFIED UNSPECIFIED UNSPECIFIED Mahe, Beatrice UNSPECIFIED UNSPECIFIED UNSPECIFIED Bouabdallah, Reda UNSPECIFIED UNSPECIFIED UNSPECIFIED Lei, Guiyuan UNSPECIFIED UNSPECIFIED UNSPECIFIED Wenger, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Wassner-Fritsch, Elisabeth UNSPECIFIED UNSPECIFIED UNSPECIFIED Hallek, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-425978
DOI:	10.1182/blood-2014-07-586610
Journal or Publication Title:	Blood
Volume:	124
Number:	14
Page Range:	S. 2196 - 2203
Date:	2014
Publisher:	AMER SOC HEMATOLOGY
Place of Publication:	WASHINGTON
ISSN:	1528-0020
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language B-CELL LYMPHOMA; MONOCLONAL-ANTIBODIES; COMPLEMENT ACTIVATION; ANTI-CD20 ANTIBODY; II GAUGUIN; HUMAN CD20; RITUXIMAB; TRIAL; FLUDARABINE; MAINTENANCE Multiple languages Hematology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/42597