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EBMT 2022 | VIALE-T: VEN+AZA after alloHSCT in AML

Charles Craddock, CBE, FRCP(UK), FRCPath, DPhil, University of Birmingham, Birmingham, UK, outlines the rationale of the Phase III VIALE-T clinical trial evaluating venetoclax plus azacitidine following allogeneic hematopoietic stem cell transplantation (alloHSCT) in patients with acute myeloid leukemia (AML) (NCT04161885). The aim of this trial is to assess whether it is possible to develop a suitable maintenance strategy for all patients with AML who have received an allotransplant. According to Prof. Craddock, optimizing post-transplant interventions is the best strategy to improve the outcomes of patients with AML. This interview took place at the 48th Annual Meeting of the European Group for Blood and Marrow Transplantation (EBMT) 2022, which was held virtually.

Transcript (edited for clarity)

Thank you very much for this opportunity to highlight the important maintenance post-transplant trial that is examining the clinical activity of a combination of azacitidine and venetoclax in patients that are grafted for acute myeloid leukemia. Maintenance therapies are now an area of intense clinical interest as a strategy to improve outcomes in patients that are grafted for AML and clearly there is now randomized data that post-transplant sorafenib maintenance is associated with improved survival...

Thank you very much for this opportunity to highlight the important maintenance post-transplant trial that is examining the clinical activity of a combination of azacitidine and venetoclax in patients that are grafted for acute myeloid leukemia. Maintenance therapies are now an area of intense clinical interest as a strategy to improve outcomes in patients that are grafted for AML and clearly there is now randomized data that post-transplant sorafenib maintenance is associated with improved survival. The question now turns as to whether we can develop suitable maintenance options for all patients transplanted for AML. So, the VIALE-T study has already delivered the Phase I/II component. There’s an MTD established and it’s now opening up in centers across Europe and globally as a randomized study with an endpoint of event-free survival. I think this is a very exciting initiative and certainly my sense is that focusing on optimizing post-transplant interventions, whether that’s a rapid taper of cyclosporine, potentially the judicious use of prophylactic donor lymphocyte infusion or pharmacological interventions is the most likely way that we’re going to be improving outcomes in this high-risk patient population.

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