Tagraxofusp in BPDCN: Real-world Registry of Safety and Effectiveness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational registry studying adults with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) who are treated with tagraxofusp. The study collects data on real-world use, safety signals, and treatment outcomes in routine care settings. Participation does not involve changing standard treatment and aligns with the treating physician’s decisions. Data are gathered from multiple centers to reflect diverse practice patterns and patient experiences.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Study contacts

• Study coordinator: Stemline Trials
• Email: clinicaltrials@menarinistemline.com
• Phone: 1-877-332-7967

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BPDCN patients treated with chemotherapy: a look back at real-world use

  This study tests how chemotherapy has performed in adults with BPDCN and compares the results to a prospective registry for ELZONRIS.

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• Tagraxofusp and venetoclax in newly diagnosed BPDCN

  This trial tests whether combining tagraxofusp with venetoclax can produce higher complete remissions in adults with newly diagnosed BPDCN.

  Recruiting at 8 sites Phase 2 French Innovative Leukemia Organisation · Amiens and 33 other locations · NCT07007052

• International registry for Blastic Plasmacytoid Dendritic Cell Neoplasm

  This study is creating a global database for people with Blastic Plasmacytoid Dendritic Cell Neoplasm to gather information on their experiences and treatments to help improve care for this rare cancer.

  Recruiting at 22 sites Immune Oncology Research Institute · Miami, Florida and 21 other locations · NCT05430971

• CD123-targeted CAR-NK therapy for relapsed/refractory AML or BPDCN

  This study is testing a new treatment using special immune cells to see if it can help people with relapsed or hard-to-treat acute myeloid leukemia or blastic plasmacytoid dendritic cell neoplasm.

  Recruiting Phase 1 Chongqing Precision Biotech Co., Ltd · Wuhan, Hubei · NCT06690827

• Using cord blood transplant and chemotherapy to treat high-risk blood cancers

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  Recruiting Phase 2 Fred Hutchinson Cancer Center · Seattle, Washington · NCT06013423

• Treatment for Blastic Plasmacytoid Dendritic Cell Neoplasm using Venetoclax and SL-401

  This study is testing a combination of venetoclax, SL-401, and chemotherapy to see if it can help people with newly diagnosed blastic plasmacytoid dendritic cell neoplasm live longer and feel better.

  Recruiting Phase 2 M.D. Anderson Cancer Center · Houston, Texas · NCT04216524

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.