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
The Lancet Haematology Jul 22, 2019
Michallet AS, et al. - Given a link between 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 and improved progression-free survival in patients with chronic lymphocytic leukaemia, researchers analyzed previously untreated patients in this single-arm, phase 2 trial in France, to assess 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 these patients. The proportion of patients reaching a complete response with bone marrow minimal residual disease less than 0·01% on day 1 of month 16 evaluated by intention to treat was considered as the primary endpoint. Findings revealed the safety as well as the activity of obinutuzumab and ibrutinib induction therapy followed by a minimal residual disease driven strategy in patients with previously untreated chronic lymphocytic leukaemia. If a maintained response in longer follow-up, including evaluating the evolution of minimal residual disease, is obtained, then first-line treatment with this strategy could be an option in patients with chronic lymphocytic leukaemia, although randomised evidence is required.
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