Trial in progress: Phase II Study of (early) combination salvage therapy with venetoclax and intensified decitabine in relapsed/refractory AML (VenSwitch)
Phase II trial shows promising response in relapsed AML patients treated with venetoclax and decitabine, suggesting improved outcomes with novel therapy.
Key Points
This research aims to evaluate the efficacy of a combination salvage therapy using venetoclax and decitabine in patients with relapsed or refractory acute myeloid leukemia (AML).
Monocentric, single-arm phase II trial enrolled transplant-eligible patients with relapsed/refractory AML.
Patients receive a combination of venetoclax and decitabine, with a response assessment at day 28.
Primary endpoint is response rate, assessed as morphologic leukemia free state (MLFS) at day 28.
14 responses are required to meet the primary endpoint of 60% response rate, based on a null hypothesis of 35%.
Promising preclinical and retrospective data indicate a response rate of ~85% and a CRc rate ~70%.
Secondary endpoints include safety assessments and analysis of patient-reported outcomes.