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Multiparameter flow cytometry of peripheral blood mononuclear cells showed that \u226512 months of treatment resulted in alterations in the proportions of multiple immune subsets, most notably CD4+ and CD8+ effector and central memory T cells and natural killer cells, and normalization of T-cell cytokine production in response to T-cell receptor stimulation. Gene expression analysis identified upregulation of multiple myeloid genes (including S100 and cathepsin family members) and inflammatory pathways over 12 months. Four patients with deep responses stopped study drugs, resulting in restoration of normal immune subsets for all study parameters except myeloid gene\/pathway expression, suggesting long-term combination venetoclax and ibrutinib irreversibly affects this population. Our findings demonstrate that long-term combination therapy is associated with immune recovery in MCL, which may allow responses to subsequent immunotherapies and suggests that this targeted therapy results in beneficial impacts on immunological recovery. This trial was registered at www.clinicaltrials.gov as #NCT02471391.<\/jats:p>","DOI":"10.1182\/bloodadvances.2020002810","type":"journal-article","created":{"date-parts":[[2020,10,8]],"date-time":"2020-10-08T20:06:10Z","timestamp":1602187570000},"page":"4849-4859","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":20,"title":["Immune recovery in patients with mantle cell lymphoma receiving long-term ibrutinib and venetoclax combination therapy"],"prefix":"10.1182","volume":"4","author":[{"given":"Joanne E.","family":"Davis","sequence":"first","affiliation":[{"name":"ACRF Translational Research Laboratory, Royal Melbourne Hospital, Melbourne, VIC, Australia;"},{"name":"Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, VIC, Australia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8790-4675","authenticated-orcid":false,"given":"Sasanka 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