Umbralisib in combination with ibrutinib in patients with relapsed or refractory chronic lymphocytic leukaemia or mantle cell lymphoma: a multicentre phase 1–1b study

Publication date: Available online 14 December 2018Source: The Lancet HaematologyAuthor(s): Matthew S Davids, Haesook T Kim, Alyssa Nicotra, Alexandra Savell, Karen Francoeur, Jeffrey M Hellman, Josie Bazemore, Hari P Miskin, Peter Sportelli, Laura Stampleman, Rodrigo Maegawa, Jens Rueter, Adam M Boruchov, Jon E Arnason, Caron A Jacobson, Eric D Jacobsen, David C Fisher, Jennifer R Brown, Blood Cancer Research Partnership of the Leukemia and Lymphoma SocietySummaryBackgroundPatients with relapsed or refractory high-risk chronic lymphocytic leukaemia or mantle cell lymphoma often do not derive durable benefit from ibrutinib monotherapy. We hypothesised that dual B-cell receptor pathway blockade would be tolerable and efficacious. We investigated a next-generation phosphoinositide-3-kinase-δ inhibitor (PI3K-δi), umbralisib, plus a Bruton tyrosine kinase inhibitor (BTKi), ibrutinib, in relapsed or refractory chronic lymphocytic leukaemia and mantle cell lymphoma.MethodsWe did an investigator-initiated, multicentre, phase 1–1b study of patients from five sites in the USA (academic and community sites). Patients were 18 years and older with relapsed or refractory chronic lymphocytic leukaemia or mantle cell lymphoma, with an Eastern Cooperative Oncology Group performance status of 2 or less, and were given umbralisib orally once daily (400 mg, 600 mg, or 800 mg) and ibrutinib orally once daily (420 mg for chronic lymphocytic leukaemia or 560 mg for mantle cell lymphoma) until ...
Source: The Lancet Haematology - Category: Hematology Source Type: research