Phase II Study Evaluating the Efficacy and Safety of the Combination of Tagraxofusp and Venetoclax in Treatment-naive Blastic Plasmacytoid Dendritic Cell Neoplasm Patients
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzona diagnoza BPDCN, brak wcześniejszego leczenia.
- •Pacjent musi mieć ukończone 18 lat.
- •Możliwość zrozumienia zasad badania i podpisania zgody.
- •Możliwość uczestniczenia w wizytach kontrolnych.
- •Ogólny stan zdrowia pozwalający na leczenie (w skali ECOG poniżej 3).
- •Prawidłowa praca nerek.
- •Prawidłowa praca serca.
✗ Disqualifies
- •Udział w innym badaniu z eksperymentalnym lekiem w ciągu ostatnich 30 dni.
- •Wcześniejsze leczenie lekami tagraxofusp lub wenetoklaks.
- •Wcześniejsze leczenie raka BPDCN jakimikolwiek lekami (poza krótkotrwałym stosowaniem jednego leku przed rozpoczęciem badania).
- •Ciąża lub karmienie piersią.
- •Znana alergia na badane leki lub ich składniki.
- •Aktywna, niekontrolowana infekcja.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 1, 2026
- Sex
- No restrictions
Therapies / drugs in trial
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
Trial contact
Jean-Pierre Marolleau, Professor
Mathilde HUNAULT, Dr
Benjamin PAPOULAR, Doctor
Safia CHEBREK, Dr
Eric DECONINCK, Professor
Justine SIAVELLIS, Dr
Aurelie RAVINET, Dr
Célia SALANOUBAT, Dr
Mathieu LECLER, Dr
Martin CARRE, Dr
Céline Berthon, Dr
Pascal Turlure, Dr
Mael Heiblig, Pr
Valerio MAISANO, Dr
Houria DEBARRI, MD
Sarah BONNET, Dr
Mario OJEDA-URIBE, Dr
Alice GARNIER, Dr
Samy CHRAIBI, Dr
Lionel ADES, Dr
Justine DECROOCQ, Dr
Felipe SUAREZ
Pierre-Yves DUMAS, Pr
Maria-Pilar GALLEGO-HERNANZ, Dr
Chantal HIMBERLIN, Dr
Jean-Baptiste MEAR, Dr
Emilie LEMASLE, Dr
Emmanuelle TAVERNIER, Dr
Célestine Pierre SIMAND, Dr
Christian RECHER, Prof
Alban VILLATE, MD
Caroline BONMATI, Dr
Fatiha MERABET, Dr
David GHEZ, Dr
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.