EHA 2019 | CLL12: ibrutinib
Othman Al-Sawaf, MD, University Hospital of Cologne, Cologne, Germany, explains the CLL12 trial (NCT02863718) which presented as a late-breaking abstract at the 24th Congress of the European Hematology Association (EHA) 2019, held in Amsterdam, Netherlands. Dr Al-Sawaf describes the randomized, placebo-controlled, double-blind phase III study, and how it compared the efficacy and safety of oral ibrutinib in previously untreated chronic lymphocytic leukemia (CLL).
Transcript (edited for clarity):
This is the CLL12 trial, that will be presented as a late-breaking abstract. It’s EHA and this is a randomized, placebo control trial in which patients with high-risk CLL, based on a particular risk score that was established by the Drummond a study group several years ago. Patients with high risk characteristics, like deletion 17p like p53 mutations, were randomized to either receive a placebo or ibrutinib.
These patients then were followed up to compare the event-free survival, and the first interim analysis of this study showed a significantly longer event-free survival of patients who started with ibrutinib, rather than than placebo. Indicating that ibrutinib extends the time until next treatment, when started in patients who would otherwise we usually just followed up.
So this is the main criteria of CLL12, these are not patients that require treatment as they don’t have any symptoms, or any derangement of their blood count but these are patients usually a standard of care would be watch and wait. But in this case patients were randomized to receive treatments although they do not have any symptoms to see whether we can extend the time to a next or actually time to first treatment by an initiating ibrutinib therapy.
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