Phase II Study of Tagraxofusp and Venetoclax Combination for Adults with Newly Diagnosed Blastic Plasmacytoid Dendritic Cell Neoplasm

What this Trial Is About

Researchers are evaluating the combination of tagraxofusp and venetoclax in adults newly diagnosed with blastic plasmacytoid dendritic cell neoplasm BPDCN. This Phase II study aims to assess how well patients respond to this treatment combination, especially focusing on the rate of complete remission after three months. The study seeks to determine if this combination improves outcomes compared to previous treatments. Participants receive a ramp-up phase of venetoclax over three days, followed by daily venetoclax at 400 mg during 28-day cycles. Tagraxofusp is given as an intravenous infusion for three consecutive days each cycle at a dose of 12 micrograms per kilogram. Patients will undergo at least three cycles, with evaluations after these to decide if further cycles up to 24 or alternative treatments like allograft are appropriate. Throughout the study, participants will be monitored for treatment response primarily after the third cycle. Assessments include clinical evaluations and laboratory tests to measure remission status. Safety and organ functions such as kidney, liver, and heart will also be checked regularly. The total duration depends on response and treatment continuation, with follow-up visits scheduled accordingly.

Phase II Study Evaluating the Efficacy and Safety of the Combination of Tagraxofusp and Venetoclax in Treatment-naive Blastic Plasmacytoid Dendritic Cell Neoplasm Patients