Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07785154

A Registry-study of ELZONRIS in Participants With 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Blastic Plasmacytoid Dendritic Cell Neoplasm Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Histiocytic Disorders, Malignant Leukemia Lymphoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University Innsbruck, Innsbruck, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tagraxofusp

Drug

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

Other names: ELZONRIS

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

Study contacts

Contact information is provided by the study sponsor or research team.

Stemline Trials

CONTACT

[email protected]

1-877-332-7967

Sponsors and collaborators

Lead sponsor

Stemline Therapeutics, Inc.

Industry

Registry information

Official study title

Post-Authorisation Registry of ELZONRIS (Tagraxofusp) in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Important dates

Study start
2024
Primary completion
2028
Study completion
2030
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.