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

The goal of this clinical trial is to study the efficacy of the tagraxofusp + venetoclax combination in treatment-naive blastic plasmacytoid dendritic cell neoplasm adult patients. The main question is to verify the response in patients after 3 cycles of tagraxofusp+venetolax and to demonstrate if the combination of tagraxofusp + venetoclax increases the rate of complete remission, assessed after 3 months of treatment. Patients will receive a ramp-up phase of venetoclax during 3 days and at least 3 cycles of venetoclax. After, the investigators will evaluate the response, and depending on the response observed, patients may receive additional cycles of treatment for a maximum of 24 cycles, or receive an allograft or discontinue the treatment in the case of therapeutic failure.

NCT Number	NCT07007052
Lead Sponsor	French Innovative Leukemia Organisation Collaborators: Stemline Therapeutics, Inc., AbbVie
Conditions	Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Enrollment	33 participants
Start Date	2025-12-11
Primary Completion	2028-12-10 (estimated)
Study Completion	2031-10-02 (estimated)
Updated on ClinicalTrials.gov	2026-07-01