A Window Study of Acalabrutinib Plus Rituximab Followed By R-Dhaox (rituximab, dexamethasone, cytarabine, oxaliplatin) and Autologous Stem Cell Transplant (ASCT) in Fit Mantle Cell Lymphoma (MCL): The Australasian Leukaemia & Lymphoma Group (ALLG) NHL33 Wamm Trial

Background: MCL is a rare and incurable disease representing 5-10% of all non-Hodgkin lymphoma cases. Although intensive chemotherapy induction and up-front ASCT can induce durable remissions in fit patients, toxicity can be significant. R-DHAOx chemoimmunotherapy provides adequate outcomes and a favourable toxicity profile compared to some other induction regimens (Le Gouill S Blood 2017). The highly selective Bruton tyrosine kinase inhibitor (BTKi) acalabrutinib has minimal off-target activity and proven efficacy in relapsed MCL (Wang M Lancet 2018), however, direct combination of BTKi & chemoimmunotherapy is toxic. Thus, it is postulated that up-front use with an acalabrutinib ‘window’ before chemoimmunotherapy, followed by maintenance after intensive chemotherapy will prolong time to next treatment and reduce overall treatment toxicity (Kuruvilla J Hematol Oncol 2017).