Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)NCT07785154
A Registry-study of ELZONRIS in Participants With BPDCN
An observational study of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), run by Stemline Therapeutics, Inc. at 41 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
- What is being tested?
- Tagraxofusp
- How many people
- 80 participants
- Where
- 41 sitesin 4 countries
- Study dates
- 26 Jun 2024to Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
41 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
41 sites in 4 countries
Italy21 sites, 21 recruiting
- Recruiting
AON SS Antonio e Biagio e C Arrigo Alessandria SOC Ematologia
Alessandria
- Recruiting
AOU di Bologna - Policlinico S. Orsola-Malpighi - UOC Ematologia
Bologna
- Recruiting
CTC U.O di Ematologia con Trapianto di Midollo Osseo - Catania
Catania
- Recruiting
ASO S. Croce e Carle - Cuneo - SC Ematologia
Cuneo
- Recruiting
AOU Arcispedale Sant'Anna Cona (FE) - UOC Ematologia e Fisiopatologia della Coagulazione
Ferrara
- Recruiting
AOU Careggi - Firenze - SOD Ematologia
Florence
- Recruiting
IRCCS AOU San Martino - Genova - UO Clinica Ematologica
Genova
- Recruiting
UO Ematologia e Terapie Cellulari, IRCCS Ospedale Policlinico San Martino - Genoa
Genova
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Milano - Ematologia
Milan
- Recruiting
SC Ematologia - ASST Grande Ospedale Metropolitano Niguarda
Milan
- Recruiting
AOU Federico II - UOC Ematologia e Trapianti di Midollo
Naples
- Recruiting
AOU di Padova - UO Ematologia
Padova
- Recruiting
AO Ospedali Riuniti Villa Sofia Cervello Palermo - UO Ematologia con UTMO
Palermo
- Recruiting
Fondazione IRCCS Policlinico San Matteo Pavia UO Ematologia
Pavia
- Recruiting
AO di Perugia, Ospedale S. Maria della Misericordia - Ematologia E Trapianto Midollo Osseo
Perugia
- Recruiting
ASL Pescara - Presidio Ospedaliero "Spirito Santo" - UOC Ematologia Clinica
Pescara
- Recruiting
AOU Policlinico Tor Vergata - Roma - Ematologia
Roma
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Roma - Area Ematologica
Roma
- Recruiting
AOU 'San Giovanni di Dio e Ruggi d'Aragona' Salerno - UOC Ematologia
Salerno
- Recruiting
AOU Città della Salute e della Scienza - Ospedale S. G. Battista Molinette - Torino - SC Ematologia
Torino
- Recruiting
ASUI di Udine - Presidio Ospedaliero "Santa Maria della Misericordia" - Clinica Ematologica
Udine
Germany14 sites, 14 recruiting
- Recruiting
Universitätsklinikum Augsburg
Augsburg
- Recruiting
Hospital Bielefeld
Bielefeld
- Recruiting
Klinikum Chemnitz
Chemnitz
- Recruiting
University Clinic of Frankfurt
Frankfurt
- Recruiting
University clinic of Freiburg
Freiburg im Breisgau
- Recruiting
Universitätsmedizin Halle
Halle
- Recruiting
Asklepios Hamburg
Hamburg
- Recruiting
University Medical Center Hamburg - Eppendorf
Hamburg
- Recruiting
Community Hospital Kiel
Kiel
- Recruiting
Universitätsklinikum Leipzig Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie
Leipzig
- Recruiting
Universitätsklinikum Schleswig-Holstein
Lübeck
- Recruiting
Technical University of Munich
Munich
- Recruiting
Oldenburgh
Oldenburg
- Recruiting
Medizinische Klinik Universitat Tübingen
Tübingen
Austria4 sites, 4 recruiting
- Recruiting
Medical University Innsbruck
Innsbruck
- Recruiting
Ordensklinikum Linz Krankenhaus der Elisabethinen Linz
Linz
- Recruiting
Salzburg Cancer Research Institute (SCRI)
Salzburg
- Recruiting
Medizinische Universitat Wien, Department for Internal Medicine I, Division of Hematology and Haemostaseology
Vienna
Switzerland2 sites, 2 recruiting
- Recruiting
Insel Gruppe AG, Bern University Hospital
Bern
- Recruiting
Luzerner Kantonsspital
Lucerne
About this study
Official title: Post-Authorisation Registry of ELZONRIS (Tagraxofusp) in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
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.
- Being tested
- Tagraxofusp
- Keywords
- BPDCN, Tagraxofusp, ELZONRIS, Registry Study, Post Authorization, Chemotherapy
- Medical subject headings
- Blastic Plasmacytoid Dendritic Cell Neoplasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TagraxofuspDrug
Also called ELZONRIS
No study medication will be provided by the sponsor during this study.
| Study group | Role | What they receive |
|---|---|---|
| Primary Cohort: Previously Untreated | Adult participants with BPDCN prescribed tagraxofusp as a first-line treatment. Receives: Drug: Tagraxofusp | |
| Exploratory Cohort: Relapsed/Refractory | Adult participants with BPDCN prescribed tagraxofusp who are relapsed/refractory to prior treatment. Receives: Drug: Tagraxofusp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Achieving Complete Response After 3 Months (+/- 1 month) of Treatment
Measured: Up to Month 4
Number of Participants Experiencing Capillary Leak Syndrome
Measured: Up to Month 51
Secondary outcomes (9)
Number of Participants Who Receive Stem Cell Transplant (SCT)
Measured: Up to Month 66
Progression-free Survival (PFS)
Measured: Up to Month 66
Overall Survival (OS)
Measured: Up to Month 66
Best Overall Response (BOR)
Measured: Up to Month 66
Duration of Response (DOR)
Measured: Up to Month 66
Number of Participants with Dose Interruptions and/or Requiring Administration of Intravenous Albumin Supplementation
Measured: Up to Month 66
Number of Participants with Adverse Events of Special Interest (AESI)
Measured: Up to Month 66
Number of Participants with Adverse Events (AEs)
Measured: Up to Month 66
Number of Doses/Cycles of Tagraxofusp Administered
Measured: Up to Month 66
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start26 Jun 2024
- Primary completionSep 2028 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)Studies of the same condition, open and under way.
- More trials run by Stemline Therapeutics, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stemline Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Stemline Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785154
- Sponsor's protocol ID
- STML-401-0521
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Individual data sharing
- No: No plan to share data.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Authorisation Registry of ELZONRIS (Tagraxofusp) in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
- ClinicalTrials.gov ID
- NCT07785154
- Acronym / sponsor ID
- STML-401-0521
- Keywords
- BPDCN, Tagraxofusp, ELZONRIS, Registry Study, Post Authorization, Chemotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Stemline Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Cohort: Previously Untreated | – | Drug: TagraxofuspAdult participants with BPDCN prescribed tagraxofusp as a first-line treatment. |
| Exploratory Cohort: Relapsed/Refractory | – | Drug: TagraxofuspAdult participants with BPDCN prescribed tagraxofusp who are relapsed/refractory to prior treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TagraxofuspAlso: ELZONRISNo study medication will be provided by the sponsor during this study. | Drug | Exploratory Cohort: Relapsed/Refractory, Primary Cohort: Previously Untreated |
Primary outcome
Number of Participants Achieving Complete Response After 3 Months (+/- 1 month) of Treatment
Time frame: Up to Month 4
Number of Participants Experiencing Capillary Leak Syndrome
Time frame: Up to Month 51
9 secondary outcomes
Number of Participants Who Receive Stem Cell Transplant (SCT)
Time frame: Up to Month 66
Progression-free Survival (PFS)
Time frame: Up to Month 66
Overall Survival (OS)
Time frame: Up to Month 66
Best Overall Response (BOR)
Time frame: Up to Month 66
Duration of Response (DOR)
Time frame: Up to Month 66
Number of Participants with Dose Interruptions and/or Requiring Administration of Intravenous Albumin Supplementation
Time frame: Up to Month 66
Number of Participants with Adverse Events of Special Interest (AESI)
Time frame: Up to Month 66
Number of Participants with Adverse Events (AEs)
Time frame: Up to Month 66
Number of Doses/Cycles of Tagraxofusp Administered
Time frame: Up to Month 66
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No. No plan to share data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director study director
Stemline Therapeutics, Inc.
41 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), run by Stemline Therapeutics, Inc. at 41 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Italy, Germany, Austria, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stemline Trials (1-877-332-7967, clinicaltrials@menarinistemline.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Achieving Complete Response After 3 Months (+/- 1 month) of Treatment (time frame: Up to Month 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.