RecruitingPhase 2NCT07007052

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

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


Sponsor

French Innovative Leukemia Organisation

Enrollment

33 participants

Start Date

Dec 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Tagraxofusp and a drug called Venetoclax for people with blastic plasmacytoid dendritic cell neoplasm (bpdcn). The study is currently recruiting participants at 34 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVenetoclax

Single interventional arm

DRUGTagraxofusp

Single interventional arm


Locations(34)

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

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

LILLE CHU - Hôpital Claude Huriez

Lille, France

Limoges CHU

Limoges, France

LYON HCL- Site Sud

Lyon, France

MARSEILLE - Institut Paoli-Calmettes

Marseille, France

METZ - CHR Metz-Thionville

Metz, France

Montpellier - Chu Saint Eloi

Montpellier, France

MULHOUSE GHRMSA - Hôpital E. Muller - Hématologie

Mulhouse, France

NANTES - Hôpital Hôtel Dieu - Hématologie Clinique

Nantes, France

Nimes CHU

Nîmes, France

APHP - Hôpital Saint-Louis - Hématologie adultes

Paris, France

APHP - HOPITAL COCHIN - Hématologie

Paris, France

AP-HP - Hôpital Necker

Paris, France

BORDEAUX - Hôpital Haut-Levêque

Pessac, France

POITIERS - Hôpital La Milétrie - Hématologie Clinique

Poitiers, France

REIMS - Hôpital Robert Debré - Hématologie Clinique

Reims, France

RENNES - CHU Pontchaillou - Hématologie Clinique

Rennes, France

ROUEN - Centre Henri Becquerel - Service Hématologie Clinique

Rouen, France

CHU SAINT-ETIENNE - iCHUSE

Saint-Etienne, France

Strasbourg - Institut de Cancerologie Strasbourg

Strasbourg, France

Toulouse - IUCT Oncopole - Service d'Hématologie

Toulouse, France

TOURS - Hôpital Bretonneau

Tours, France

NANCY - CHU de Brabois

Vandœuvre-lès-Nancy, France

VERSAILLES - Hôpital André Mignot

Versailles, France

Villejuif Igr - Gustave Roussy

Villejuif, France

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NCT07007052


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