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NCT Number: NCT07785180

A Non-interventional Study of Participants With BPDCN Treated With Chemotherapy

The main goal of this study is to investigate the effectiveness and safety of chemotherapy agents in the treatment of participants with BPDCN and to provide comparator arm data to the prospective ELZONRIS registry study (STML-401-0521).

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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

Aarhus University Hospital, Aarhus, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Alive, deceased, or unreachable participants (as permitted by local regulation), aged ≥18 years at the start of first-line treatment for BPDCN, and treated with chemotherapy regimens (at a minimum) as first-line treatment for BPDCN from May 2016
  • Diagnosed with BPDCN, based on clinical, laboratory, and imaging (where performed per institutional practice) assessments, with a demonstration of a specific immunophenotype (either by immunohistochemistry or flow cytometry), particularly CD4, CD56, and CD123
  • Participants (or their legally authorized representatives) who have signed the informed consent and privacy form, where required as per local regulation

Exclusion criteria

  • Participant has received an investigational agent as first-line therapy for BPDCN
  • Participant has received first-line therapy for BPDCN in an interventional clinical trial

Treatment and study plan

Chemotherapy

Drug

Several chemotherapy regimens can be considered (acute myeloid leukemia-like, acute lymphocytic leukemia-like, lymphoma-like). The choice of the regimen, as well as dosing and schedules, are based on the institution's and the health care provider's preferences.

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

Primary outcomes

  1. Objective Response Rate

    Time frame: Baseline through Month 18

  2. Composite Compete Response

    Time frame: Baseline through Month 18

  3. Number of Participants Bridged to Stem Cell Transplant

    Time frame: Baseline through Month 18

  4. Duration of Response

    Time frame: Baseline through Month 18

  5. Real-world Progression-free Survival

    Time frame: Baseline through Month 18

  6. Overall Survival

    Time frame: Baseline through Month 18

  7. Number of Participants with Treatment-emergent Adverse Events

    Time frame: Baseline through Month 18

  8. Number of Participants Requiring Transfusions

    Time frame: Baseline through Month 18

  9. Duration of Treatments Received and Hospitalization

    Time frame: Baseline through Month 18

Secondary outcomes

  1. Time to Next Treatment

    Time frame: Baseline through Month 26

  2. Number of Different First-line Treatment Regimens and Sequences Received

    Time frame: Baseline through Month 26

Study contacts

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

Stemline Trials

CONTACT

[email protected]

1-877-332-796

Sponsors and collaborators

Lead sponsor

Stemline Therapeutics, Inc.

Industry

Registry information

Official study title

Retrospective Study of Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Treated With Chemotherapy Agents

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
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.

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