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Can a targeted therapy tame a rare blood cancer in everyday practice?

NCT ID NCT07785154

Disease control Sponsor: Stemline Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This registry study is following adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and aggressive blood cancer, who are being treated with the drug tagraxofusp (ELZONRIS) in routine clinical care. The goal is to see how effective the treatment is at achieving complete remission and to monitor its safety, particularly the risk of capillary leak syndrome. By collecting real-world data, researchers hope to better understand how tagraxofusp performs outside of clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tagraxofusp (ELZONRIS), a targeted therapy for BPDCN
What this could lead to
If successful, this registry could confirm that tagraxofusp is a safe and effective treatment for BPDCN in real-world settings, potentially improving outcomes for patients with this rare cancer.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by patient differences and real-world variability, and tagraxofusp carries risks like capillary leak syndrome.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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, informed consent 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.

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Conditions

The condition(s) this trial relates to.

Blastic Plasmacytoid Dendritic Cell Neoplasm CD4+/CD56+ hematodermic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Blastic plasmacytoid dendritic cell neoplasm (BPDCN)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    41 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AO Ospedali Riuniti Villa Sofia Cervello Palermo - UO Ematologia con UTMO

    RECRUITING

    Palermo, Italy

  • AO di Perugia, Ospedale S. Maria della Misericordia - Ematologia E Trapianto Midollo Osseo

    RECRUITING

    Perugia, Italy

  • AON SS Antonio e Biagio e C Arrigo Alessandria SOC Ematologia

    RECRUITING

    Alessandria, Italy

  • AOU 'San Giovanni di Dio e Ruggi d'Aragona' Salerno - UOC Ematologia

    RECRUITING

    Salerno, Italy

  • AOU Arcispedale Sant'Anna Cona (FE) - UOC Ematologia e Fisiopatologia della Coagulazione

    RECRUITING

    Ferrara, Italy

  • AOU Careggi - Firenze - SOD Ematologia

    RECRUITING

    Florence, Italy

  • AOU Città della Salute e della Scienza - Ospedale S. G. Battista Molinette - Torino - SC Ematologia

    RECRUITING

    Torino, Italy

  • AOU Federico II - UOC Ematologia e Trapianti di Midollo

    RECRUITING

    Naples, Italy

  • AOU Policlinico Tor Vergata - Roma - Ematologia

    RECRUITING

    Roma, Italy

  • AOU di Bologna - Policlinico S. Orsola-Malpighi - UOC Ematologia

    RECRUITING

    Bologna, Italy

  • AOU di Padova - UO Ematologia

    RECRUITING

    Padova, Italy

  • ASL Pescara - Presidio Ospedaliero "Spirito Santo" - UOC Ematologia Clinica

    RECRUITING

    Pescara, Italy

  • ASO S. Croce e Carle - Cuneo - SC Ematologia

    RECRUITING

    Cuneo, Italy

  • ASUI di Udine - Presidio Ospedaliero "Santa Maria della Misericordia" - Clinica Ematologica

    RECRUITING

    Udine, Italy

  • Asklepios Hamburg

    RECRUITING

    Hamburg, Germany

  • CTC U.O di Ematologia con Trapianto di Midollo Osseo - Catania

    RECRUITING

    Catania, Italy

  • Community Hospital Kiel

    RECRUITING

    Kiel, Germany

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Milano - Ematologia

    RECRUITING

    Milan, Italy

  • Fondazione IRCCS Policlinico San Matteo Pavia UO Ematologia

    RECRUITING

    Pavia, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Roma - Area Ematologica

    RECRUITING

    Roma, Italy

  • Hospital Bielefeld

    RECRUITING

    Bielefeld, Germany

  • IRCCS AOU San Martino - Genova - UO Clinica Ematologica

    RECRUITING

    Genova, Italy

  • Insel Gruppe AG, Bern University Hospital

    RECRUITING

    Bern, Switzerland

  • Klinikum Chemnitz

    RECRUITING

    Chemnitz, Germany

  • Luzerner Kantonsspital

    RECRUITING

    Lucerne, Switzerland

  • Medical University Innsbruck

    RECRUITING

    Innsbruck, Austria

  • Medizinische Klinik Universitat Tübingen

    RECRUITING

    Tübingen, Germany

  • Medizinische Universitat Wien, Department for Internal Medicine I, Division of Hematology and Haemostaseology

    RECRUITING

    Vienna, Austria

  • Oldenburgh

    RECRUITING

    Oldenburg, Germany

  • Ordensklinikum Linz Krankenhaus der Elisabethinen Linz

    RECRUITING

    Linz, Austria

  • SC Ematologia - ASST Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, Italy

  • Salzburg Cancer Research Institute (SCRI)

    RECRUITING

    Salzburg, Austria

  • Technical University of Munich

    RECRUITING

    Munich, Germany

  • UO Ematologia e Terapie Cellulari, IRCCS Ospedale Policlinico San Martino - Genoa

    RECRUITING

    Genova, Italy

  • University Clinic of Frankfurt

    RECRUITING

    Frankfurt, Germany

  • University Medical Center Hamburg - Eppendorf

    RECRUITING

    Hamburg, Germany

  • University clinic of Freiburg

    RECRUITING

    Freiburg im Breisgau, Germany

  • Universitätsklinikum Augsburg

    RECRUITING

    Augsburg, Germany

  • Universitätsklinikum Leipzig Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie

    RECRUITING

    Leipzig, Germany

  • Universitätsklinikum Schleswig-Holstein

    RECRUITING

    Lübeck, Germany

  • Universitätsmedizin Halle

    RECRUITING

    Halle, Germany

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