Woman and Man
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Extract
The principal research question this trial aims to answer is does obinutuzumab given within 3-12 months following a good response to prior treatment for chronic lymphocytic leukaemia (CLL) improve the length of time that patients are progression free when compared to having no consolidation treatment. The phase II primary objective is to determine the rate of achieving MRD negativity and to assess the safety of obinutuzumab in a consolidation setting. The phase III primary objective is to compare consolidation therapy with obinutuzumab against no consolidation therapy with respect to progression-free survival in participants who responded to previous therapy with a complete or good partial remission with low levels of MRD.
Inclusion criteria
- Chronic Lymphocytic Leukaemia (CLL)