1
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: not found

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

      Read this article at

      ScienceOpenPublisherPubMed
      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          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.

          Related collections

          Author and article information

          Journal
          Blood
          Blood
          1528-0020
          0006-4971
          Oct 2 2014
          : 124
          : 14
          Affiliations
          [1 ] Département d'Hématologie, Unités Mixtes de Recherche-Centre National de la Recherche Scientifique 5235, Centre Hospitalier Universitaire de Montpellier, Montpellier, France;
          [2 ] Service d'Hematologie Clinique, Unité d'Investigation Clinique, Institut National de la Santé et de la Recherche Médicale 1414, Centre Hospitalier Universitaire Pontchaillou, Rennes, France;
          [3 ] Service d'Hématologie Clinique et Thérapie Cellulaire, Hôpital du Haut-Lévèque, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France;
          [4 ] Service d'Hématologie, Centre Hospitalier Universitaire de Lille, Lille, France;
          [5 ] Service d'Hématologie, Groupe Hospitalier Pitié-Salpêtrière, Paris, France;
          [6 ] Unité Hémopathies Lymphoïdes, Centre Hospitalier Universitaire Henri Mondor, Creteil, France;
          [7 ] Département d'Hématologie, Centre Hospitalier Universitaire Nantes, Nantes, France;
          [8 ] Centre de Lutte Contre le Cancer Paoli-Calmettes, Marseille, France;
          [9 ] Pharma Development Biostatistics, Roche Products, Welwyn Garden City, United Kingdom;
          [10 ] Department of Medical Oncology and.
          [11 ] Pharma Development Oncology, F. Hoffmann-La Roche, Basel, Switzerland; and.
          [12 ] First Department of Internal Medicine, University of Cologne, Cologne, Germany.
          Article
          blood-2014-07-586610
          10.1182/blood-2014-07-586610
          25143487
          8671af9b-1184-48ec-b110-5c3cbdbd9909
          © 2014 by The American Society of Hematology.
          History

          Comments

          Comment on this article