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Obinutuzumab (GA101) in relapsed/refractory chronic lymphocytic leukemia: final data from the phase 1/2 GAUGUIN study

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.
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https://hal-univ-rennes1.archives-ouvertes.fr/hal-01147035
Contributor : Laurent Jonchère <>
Submitted on : Wednesday, April 29, 2015 - 3:01:53 PM
Last modification on : Wednesday, August 19, 2020 - 11:17:04 AM

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Guillaume Cartron, Sophie de Guibert, Marie-Sarah Dilhuydy, Franck Morschhauser, Veronique Leblond, et al.. Obinutuzumab (GA101) in relapsed/refractory chronic lymphocytic leukemia: final data from the phase 1/2 GAUGUIN study. Blood, American Society of Hematology, 2014, 124 (14), pp.2196--2202. ⟨10.1182/blood-2014-07-586610⟩. ⟨hal-01147035⟩

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