ClinicalTrials.gg
RecruitingNCT07785154Updated Aug 25, 2026

A Registry-study of ELZONRIS in Participants With BPDCN

An observational study in Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), sponsored by Stemline Therapeutics, Inc.. Recruiting at 41 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by Stemline Therapeutics, Inc. (part of Menarini Group) · Observational

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Keywords

  • BPDCN
  • Tagraxofusp
  • ELZONRIS
  • Registry Study
  • Post Authorization
  • Chemotherapy
03

In context

Blastic Plasmacytoid Dendritic Cell Neoplasm

45 studies on the registry are indexed under Blastic Plasmacytoid Dendritic Cell Neoplasm; 15 are open to participants now.

Browse Blastic Plasmacytoid Dendritic Cell Neoplasm studies →

Lead sponsor

Stemline Therapeutics, Inc. is the lead sponsor of 23 studies on the registry; 7 are open to participants now.

First submitted after Stemline Therapeutics, Inc. became part of Menarini Group.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Eligibility criteria

Key Inclusion Criteria:

  • 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, form (ICF) signature or has started treatment.

Key Exclusion Criteria:

  • 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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • Primary Cohort: Previously Untreated

    Adult participants with BPDCN prescribed tagraxofusp as a first-line treatment.

    Drug: Tagraxofusp

  • Exploratory Cohort: Relapsed/Refractory

    Adult participants with BPDCN prescribed tagraxofusp who are relapsed/refractory to prior treatment.

    Drug: Tagraxofusp

Interventions

  • No study medication will be provided by the sponsor during this study.

    Also known as: ELZONRIS

06

What researchers measure

Primary outcomes

  1. Number of Participants Achieving Complete Response After 3 Months (+/- 1 month) of Treatment

    Time frame: Up to Month 4

  2. Number of Participants Experiencing Capillary Leak Syndrome

    Time frame: Up to Month 51

Secondary outcomes

  1. Number of Participants Who Receive Stem Cell Transplant (SCT)

    Time frame: Up to Month 66

  2. Progression-free Survival (PFS)

    Time frame: Up to Month 66

  3. Overall Survival (OS)

    Time frame: Up to Month 66

  4. Best Overall Response (BOR)

    Time frame: Up to Month 66

  5. Duration of Response (DOR)

    Time frame: Up to Month 66

  6. Number of Participants with Dose Interruptions and/or Requiring Administration of Intravenous Albumin Supplementation

    Time frame: Up to Month 66

  7. Number of Participants with Adverse Events of Special Interest (AESI)

    Time frame: Up to Month 66

  8. Number of Participants with Adverse Events (AEs)

    Time frame: Up to Month 66

  9. Number of Doses/Cycles of Tagraxofusp Administered

    Time frame: Up to Month 66

07

Study locations

41 of 41 sites recruiting
  • Medical University Innsbruck
    Innsbruck, Austria
    Recruiting
  • Ordensklinikum Linz Krankenhaus der Elisabethinen Linz
    Linz, Austria
    Recruiting
  • Salzburg Cancer Research Institute (SCRI)
    Salzburg, Austria
    Recruiting
  • Medizinische Universitat Wien, Department for Internal Medicine I, Division of Hematology and Haemostaseology
    Vienna, Austria
    Recruiting
  • Universitätsklinikum Augsburg
    Augsburg, Germany
    Recruiting
  • Hospital Bielefeld
    Bielefeld, Germany
    Recruiting
  • Klinikum Chemnitz
    Chemnitz, Germany
    Recruiting
  • University Clinic of Frankfurt
    Frankfurt, Germany
    Recruiting
  • University clinic of Freiburg
    Freiburg im Breisgau, Germany
    Recruiting
  • Universitätsmedizin Halle
    Halle, Germany
    Recruiting
  • Asklepios Hamburg
    Hamburg, Germany
    Recruiting
  • University Medical Center Hamburg - Eppendorf
    Hamburg, Germany
    Recruiting
  • Community Hospital Kiel
    Kiel, Germany
    Recruiting
  • Universitätsklinikum Leipzig Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie
    Leipzig, Germany
    Recruiting
  • Universitätsklinikum Schleswig-Holstein
    Lübeck, Germany
    Recruiting
  • Technical University of Munich
    Munich, Germany
    Recruiting
  • Oldenburgh
    Oldenburg, Germany
    Recruiting
  • Medizinische Klinik Universitat Tübingen
    Tübingen, Germany
    Recruiting
  • AON SS Antonio e Biagio e C Arrigo Alessandria SOC Ematologia
    Alessandria, Italy
    Recruiting
  • AOU di Bologna - Policlinico S. Orsola-Malpighi - UOC Ematologia
    Bologna, Italy
    Recruiting
  • CTC U.O di Ematologia con Trapianto di Midollo Osseo - Catania
    Catania, Italy
    Recruiting
  • ASO S. Croce e Carle - Cuneo - SC Ematologia
    Cuneo, Italy
    Recruiting
  • AOU Arcispedale Sant'Anna Cona (FE) - UOC Ematologia e Fisiopatologia della Coagulazione
    Ferrara, Italy
    Recruiting
  • AOU Careggi - Firenze - SOD Ematologia
    Florence, Italy
    Recruiting
  • IRCCS AOU San Martino - Genova - UO Clinica Ematologica
    Genova, Italy
    Recruiting
  • UO Ematologia e Terapie Cellulari, IRCCS Ospedale Policlinico San Martino - Genoa
    Genova, Italy
    Recruiting
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Milano - Ematologia
    Milan, Italy
    Recruiting
  • SC Ematologia - ASST Grande Ospedale Metropolitano Niguarda
    Milan, Italy
    Recruiting
  • AOU Federico II - UOC Ematologia e Trapianti di Midollo
    Naples, Italy
    Recruiting
  • AOU di Padova - UO Ematologia
    Padova, Italy
    Recruiting
  • AO Ospedali Riuniti Villa Sofia Cervello Palermo - UO Ematologia con UTMO
    Palermo, Italy
    Recruiting
  • Fondazione IRCCS Policlinico San Matteo Pavia UO Ematologia
    Pavia, Italy
    Recruiting
  • AO di Perugia, Ospedale S. Maria della Misericordia - Ematologia E Trapianto Midollo Osseo
    Perugia, Italy
    Recruiting
  • ASL Pescara - Presidio Ospedaliero "Spirito Santo" - UOC Ematologia Clinica
    Pescara, Italy
    Recruiting
  • AOU Policlinico Tor Vergata - Roma - Ematologia
    Roma, Italy
    Recruiting
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Roma - Area Ematologica
    Roma, Italy
    Recruiting
  • AOU 'San Giovanni di Dio e Ruggi d'Aragona' Salerno - UOC Ematologia
    Salerno, Italy
    Recruiting
  • AOU Città della Salute e della Scienza - Ospedale S. G. Battista Molinette - Torino - SC Ematologia
    Torino, Italy
    Recruiting
  • ASUI di Udine - Presidio Ospedaliero "Santa Maria della Misericordia" - Clinica Ematologica
    Udine, Italy
    Recruiting
  • Insel Gruppe AG, Bern University Hospital
    Bern, Switzerland
    Recruiting
  • Luzerner Kantonsspital
    Lucerne, Switzerland
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — No plan to share data.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07785154
Responsible party
Sponsor
First posted
Aug 25, 2026
Start date
Jun 26, 2024
Primary completion
Sep 2028 (estimated)
Completion
Jun 2030 (estimated)
Last update
Aug 25, 2026

Study contacts

Stemline Trials
Contact
clinicaltrials@menarinistemline.com
1-877-332-7967
Medical Director
study director · Stemline Therapeutics, Inc.
View the source record on ClinicalTrials.gov ↗

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