A Registry-study of ELZONRIS in Participants With BPDCN
Post-Authorisation Registry of ELZONRIS (Tagraxofusp) in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
1 other identifier
observational
80
4 countries
41
Brief Summary
The main goal of this registry study is to investigate the effectiveness and safety of tagraxofusp in the treatment of adult participants with BPDCN in the real-world clinical practice setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2024
Longer than P75 for all trials
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 26, 2024
CompletedFirst Submitted
Initial submission to the registry
August 20, 2026
CompletedFirst Posted
Study publicly available on registry
August 25, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2030
August 25, 2026
August 1, 2026
4.2 years
August 20, 2026
August 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants Achieving Complete Response After 3 Months (+/- 1 month) of Treatment
Up to Month 4
Number of Participants Experiencing Capillary Leak Syndrome
Up to Month 51
Secondary Outcomes (9)
Number of Participants Who Receive Stem Cell Transplant (SCT)
Up to Month 66
Progression-free Survival (PFS)
Up to Month 66
Overall Survival (OS)
Up to Month 66
Best Overall Response (BOR)
Up to Month 66
Duration of Response (DOR)
Up to Month 66
- +4 more secondary outcomes
Study Arms (2)
Primary Cohort: Previously Untreated
Adult participants with BPDCN prescribed tagraxofusp as a first-line treatment.
Exploratory Cohort: Relapsed/Refractory
Adult participants with BPDCN prescribed tagraxofusp who are relapsed/refractory to prior treatment.
Interventions
No study medication will be provided by the sponsor during this study.
Eligibility Criteria
Adult participants with BPDCN who are to be treated (or have recently started treatment) with tagraxofusp as first-line therapy according to the European Union summary of product characteristics in standard clinical practice setting across Europe. Participants who are relapse/refractory to prior treatment will also be investigated.
You may qualify if:
- Diagnosed with BPDCN, confirmed by hematopathology and biomarkers (inclusive of CD123, CD4, and CD56).
- Planning to start treatment with tagraxofusp monotherapy for BPDCN at the time of, or within 6 months prior to, informed consent form (ICF) signature or has started treatment.
You may not qualify if:
- Currently (or planning to) participating in another study or registry where BPDCN treatment outcomes are reported.
- Participating in an interventional clinical trial at the time of ICF signature.
- Known allergic reactions to components of tagraxofusp.
- Note: Other protocol-specified criteria apply.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Medical University Innsbruck
Innsbruck, Austria
Ordensklinikum Linz Krankenhaus der Elisabethinen Linz
Linz, Austria
Salzburg Cancer Research Institute (SCRI)
Salzburg, Austria
Medizinische Universitat Wien, Department for Internal Medicine I, Division of Hematology and Haemostaseology
Vienna, Austria
Universitätsklinikum Augsburg
Augsburg, Germany
Hospital Bielefeld
Bielefeld, Germany
Klinikum Chemnitz
Chemnitz, Germany
University Clinic of Frankfurt
Frankfurt, Germany
University clinic of Freiburg
Freiburg im Breisgau, Germany
Universitätsmedizin Halle
Halle, Germany
Asklepios Hamburg
Hamburg, Germany
University Medical Center Hamburg - Eppendorf
Hamburg, Germany
Community Hospital Kiel
Kiel, Germany
Universitätsklinikum Leipzig Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie
Leipzig, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Germany
Technical University of Munich
Munich, Germany
Oldenburgh
Oldenburg, Germany
Medizinische Klinik Universitat Tübingen
Tübingen, Germany
AON SS Antonio e Biagio e C Arrigo Alessandria SOC Ematologia
Alessandria, Italy
AOU di Bologna - Policlinico S. Orsola-Malpighi - UOC Ematologia
Bologna, Italy
CTC U.O di Ematologia con Trapianto di Midollo Osseo - Catania
Catania, Italy
ASO S. Croce e Carle - Cuneo - SC Ematologia
Cuneo, Italy
AOU Arcispedale Sant'Anna Cona (FE) - UOC Ematologia e Fisiopatologia della Coagulazione
Ferrara, Italy
AOU Careggi - Firenze - SOD Ematologia
Florence, Italy
IRCCS AOU San Martino - Genova - UO Clinica Ematologica
Genova, Italy
UO Ematologia e Terapie Cellulari, IRCCS Ospedale Policlinico San Martino - Genoa
Genova, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Milano - Ematologia
Milan, Italy
SC Ematologia - ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
AOU Federico II - UOC Ematologia e Trapianti di Midollo
Naples, Italy
AOU di Padova - UO Ematologia
Padova, Italy
AO Ospedali Riuniti Villa Sofia Cervello Palermo - UO Ematologia con UTMO
Palermo, Italy
Fondazione IRCCS Policlinico San Matteo Pavia UO Ematologia
Pavia, Italy
AO di Perugia, Ospedale S. Maria della Misericordia - Ematologia E Trapianto Midollo Osseo
Perugia, Italy
ASL Pescara - Presidio Ospedaliero "Spirito Santo" - UOC Ematologia Clinica
Pescara, Italy
AOU Policlinico Tor Vergata - Roma - Ematologia
Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Roma - Area Ematologica
Roma, Italy
AOU 'San Giovanni di Dio e Ruggi d'Aragona' Salerno - UOC Ematologia
Salerno, Italy
AOU Città della Salute e della Scienza - Ospedale S. G. Battista Molinette - Torino - SC Ematologia
Torino, Italy
ASUI di Udine - Presidio Ospedaliero "Santa Maria della Misericordia" - Clinica Ematologica
Udine, Italy
Insel Gruppe AG, Bern University Hospital
Bern, Switzerland
Luzerner Kantonsspital
Lucerne, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Stemline Therapeutics, Inc.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2026
First Posted
August 25, 2026
Study Start
June 26, 2024
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
June 1, 2030
Last Updated
August 25, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share
No plan to share data.