A Non-interventional Study of Participants With BPDCN Treated With Chemotherapy
Retrospective Study of Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Treated With Chemotherapy Agents
1 other identifier
observational
140
11 countries
67
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2025
Typical duration for all trials
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 17, 2025
CompletedFirst Submitted
Initial submission to the registry
August 20, 2026
CompletedFirst Posted
Study publicly available on registry
August 25, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
August 25, 2026
August 1, 2026
1.5 years
August 20, 2026
August 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Objective Response Rate
Baseline through Month 18
Composite Compete Response
Baseline through Month 18
Number of Participants Bridged to Stem Cell Transplant
Baseline through Month 18
Duration of Response
Baseline through Month 18
Real-world Progression-free Survival
Baseline through Month 18
Overall Survival
Baseline through Month 18
Number of Participants with Treatment-emergent Adverse Events
Baseline through Month 18
Number of Participants Requiring Transfusions
Baseline through Month 18
Duration of Treatments Received and Hospitalization
Baseline through Month 18
Secondary Outcomes (2)
Time to Next Treatment
Baseline through Month 26
Number of Different First-line Treatment Regimens and Sequences Received
Baseline through Month 26
Study Arms (1)
Chemotherapy
Adult participants with BPDCN who have been treated with chemotherapy regimens (at a minimum) as first-line treatment from May 2016.
Interventions
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.
Eligibility Criteria
Adult participants with BPDCN who have been treated with chemotherapy regimens (at a minimum) as first-line treatment from May 2016 at sites in Europe.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (67)
Aarhus University Hospital
Aarhus, Denmark
Odense University Hospital
Odense, Denmark
Centre Hospitalier Universitaire Besancon
Besançon, France
Hôpital Avicenne
Bobigny, France
Centre Hospitalier Universitaire de Bordeaux - Hôpital Haut-Lévêque
Bordeaux, France
Henri Mondor University Hospital
Créteil, France
Centre Hospitalier Universitaire de Nice
Nice, France
Saint-Antoine Hospital
Paris, France
Saint-Louis Hospital
Paris, France
Centre Hospitalier Universitaire Poitiers
Poitiers, France
Centre Hospitalier Universitaire de Tours
Tours, France
Gustave Roussy
Villejuif, France
Klinikum Bremen-Mitte gGmbH
Bremen, Germany
Klinikum Chemnitz gGmbH
Chemnitz, Germany
Uniklinikum Leipzig
Leipzig, Germany
University Hospital Schleswig Holstein Campus Lübeck
Lübeck, Germany
Klinikum rechst der Isar, Technische Universität München
Munich, Germany
Klinikum Oldenburg AöR
Oldenburg, Germany
Uniklinikum Würzburg
Würzburg, Germany
Evaggelismos Hospital, Dept. Hematology-Lymphoma and BMT Unit
Athens, Greece
National and Kapodistrian University of Athens, General Hospital of Athens
Athens, Greece
University of Patras
Pátrai, Greece
A.O. SS Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico
Bari, Italy
IRCCS Azienda Ospedaliero Universitaria di Bologna
Bologna, Italy
ASST Spedali Civili
Brescia, Italy
A.O.U. Policlinico Rodolico San Marco
Catania, Italy
A.O.U. Careggi
Florence, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
IEO Istituto Europeo di Oncologia
Milan, Italy
Azienda Ospedaliera Universitaria Federico II
Naples, Italy
A.O.U. Maggiore della Carità
Novara, Italy
Azienda Ospedale-Università di Padova
Padova, Italy
A.O.O.R. Villa Sofia- Cervello
Palermo, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Presidio Ospedaliero Santo Spitiro
Pescara, Italy
Ospedale S. Maria delle Croci
Ravenna, Italy
A.O.U. Sant'Andrea
Roma, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy
Policlinico Tor Vergata
Roma, Italy
A.O.U. San Giovanni di Dio e Ruggi D'Aragona
Salerno, Italy
A.O.U. Città della Salute e della Scienza
Torino, Italy
AO Ordine Mauriziano di Torino
Torino, Italy
ASUFC P.O. Santa Maria della Misericordia
Udine, Italy
Amsterdam UMC
Amsterdam, Netherlands
UMC Groningen
Groningen, Netherlands
Radboud Universitair Medisch Centrum
Nijmegen, Netherlands
Institute of Hematology and Transfusion Medicine
Warsaw, Poland
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, Poland
Hospital de Santa Maria
Lisbon, Portugal
Hospital General de Albacete
Albacete, Spain
Hospital General Dr Balmis
Alicante, Spain
Hospital Germans Trias i Pujol
Badalona, Spain
Hospital Universitario De Burgos
Burgos, Spain
Hospital San Pedro de Alcántara
Cáceres, Spain
Hospital Universitario Reina Sofia
Córdoba, Spain
Fundacion Jimenez Diaz
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
MD Anderson Cancer Center
Madrid, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Hospital La Fe
Valencia, Spain
Sahlgrenska University Hospital - Section for hematologi and coagulation
Gothenburg, Sweden
King's College Hospital
London, United Kingdom
University College London Hospitals
London, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Stemline Therapeutics, Inc.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2026
First Posted
August 25, 2026
Study Start
October 17, 2025
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
August 25, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share
No plan to share data.