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.

• Authors: Guillaume Cartron, Sophie de Guibert, Marie-Sarah Dilhuydy, Franck Morschhauser, Veronique Leblond, Jehan Dupuis, Beatrice Mahe, Reda Bouabdallah, Guiyuan Lei, Michael Wenger, Elisabeth Wassner-Fritsch, Michael Hallek
• Journal: Blood (Blood) Vol. 124 Issue 14 Pg. 2196-202 (Oct 02 2014) ISSN: 1528-0020 [Electronic] United States
• PMID: 25143487 (Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2014 by The American Society of Hematology.

Chemical References

• Antibodies, Monoclonal, Humanized
• Antineoplastic Agents
• obinutuzumab

Topics

• Adult
• Aged
• Aged, 80 and over
• Antibodies, Monoclonal, Humanized (therapeutic use)
• Antineoplastic Agents (therapeutic use)
• Drug Resistance, Neoplasm
• Female
• Humans
• Leukemia, Lymphocytic, Chronic, B-Cell (drug therapy)
• Male
• Middle Aged
• Recurrence
• Time Factors
• Treatment Outcome