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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Single interventional arm
Single interventional arm
AMIENS - CH Amiens Picardie Site Sud
Amiens, France
ANGERS - CHU - Maladies du sang
Angers, France
ARGENTEUIL - Centre hospitalier Victor Dupouy
Argenteuil, France
AVIGNON - Centre Hospitalier
Avignon, France
BESANCON - Hôpital Jean Minjoz - Hématologie
Besançon, France
CLAMART - Hôpital d'Instruction des Armées de Percy
Proportion of participants who achieve a cCR (CR or Cri or CRc) after 3 TAGVEN cycles
Evaluation will be done with a bone marrow aspirate, cytogenetics, metabolic imaging, study of MRD by NGS and flow-cytometry and SWAT SCORE
Time frame: From enrollment to the end of the third 28 days-cycle
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Clamart, France
Clermont-Ferrand - Chu Estaing
Clermont-Ferrand, France
Corbeil-Essonnes - Ch Sud Francilien
Corbeil-Essonnes, France
AP-HP- CRETEIL - CHU Henri Mondor
Créteil, France
Grenoble CHU - Hématologie Clinique
Grenoble, France
...and 24 more locations