Obinutuzumab and ibrutinib induction therapy followed by a minimal residual disease-driven strategy in patients with chronic lymphocytic leukaemia (ICLL07 FILO): a single-arm, multicentre, phase 2 trial
Publication date: Available online 16 July 2019Source: The Lancet HaematologyAuthor(s): Anne-Sophie Michallet, Marie-Sarah Dilhuydy, Fabien Subtil, Valerie Rouille, Beatrice Mahe, Kamel Laribi, Bruno Villemagne, Gilles Salles, Olivier Tournilhac, Alain Delmer, Christelle Portois, Brigitte Pegourie, Veronique Leblond, Cecile Tomowiak, Sophie de Guibert, Frederique Orsini, Anne Banos, Philippe Carassou, Guillaume Cartron, Luc Mathieu ForneckerSummaryBackgroundIn patients with chronic lymphocytic leukaemia, achievement of a complete response with minimal residual disease of less than 0·01% (ie, <1 chronic lymphocytic leukaemia cell per 10 000 leukocytes) in bone marrow has been associated with improved progression-free survival. We aimed to explore the activity of induction therapy for 9 months with obinutuzumab and ibrutinib, followed up with a minimal residual disease-driven therapeutic strategy for 6 additional months, in previously untreated patients.MethodsWe did a single-arm, phase 2 trial in 27 university hospitals, general hospitals, and specialist cancer centres in France. Eligible patients were at least 18 years old and previously untreated, and had immunophenotypically confirmed B-cell chronic lymphocytic leukaemia; an Eastern Cooperative Oncology Group (ECOG) performance status score of less than 2; a Binet stage C according to IWCLL 2008 criteria or Binet stage A and B with active disease; no 17p deletion or absence of p53 mutation; and were considered medica...
Source: The Lancet Haematology - Category: Hematology Source Type: research
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