Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)NCT07785180
A Non-interventional Study of Participants With BPDCN Treated With Chemotherapy
An observational study of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), run by Stemline Therapeutics, Inc. at 67 sites in 11 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
- What is being tested?
- Chemotherapy
- How many people
- 140 participants
- Where
- 67 sitesin 11 countries
- Study dates
- 17 Oct 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
67 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
67 sites in 11 countries
Italy23 sites, 23 recruiting
- Recruiting
A.O. SS Antonio e Biagio e Cesare Arrigo
Alessandria
- Recruiting
Azienda Ospedaliero Universitaria Consorziale Policlinico
Bari
- Recruiting
IRCCS Azienda Ospedaliero Universitaria di Bologna
Bologna
- Recruiting
ASST Spedali Civili
Brescia
- Recruiting
A.O.U. Policlinico Rodolico San Marco
Catania
- Recruiting
A.O.U. Careggi
Florence
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan
- Recruiting
IEO Istituto Europeo di Oncologia
Milan
- Recruiting
Azienda Ospedaliera Universitaria Federico II
Naples
- Recruiting
A.O.U. Maggiore della Carità
Novara
- Recruiting
Azienda Ospedale-Università di Padova
Padova
- Recruiting
A.O.O.R. Villa Sofia- Cervello
Palermo
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia
- Recruiting
Presidio Ospedaliero Santo Spitiro
Pescara
- Recruiting
Ospedale S. Maria delle Croci
Ravenna
- Recruiting
A.O.U. Sant'Andrea
Roma
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma
- Recruiting
Policlinico Tor Vergata
Roma
- Recruiting
A.O.U. San Giovanni di Dio e Ruggi D'Aragona
Salerno
- Recruiting
A.O.U. Città della Salute e della Scienza
Torino
- Recruiting
AO Ordine Mauriziano di Torino
Torino
- Recruiting
ASUFC P.O. Santa Maria della Misericordia
Udine
Spain12 sites, 12 recruiting
- Recruiting
Hospital General de Albacete
Albacete
- Recruiting
Hospital General Dr Balmis
Alicante
- Recruiting
Hospital Germans Trias i Pujol
Badalona
- Recruiting
Hospital Universitario De Burgos
Burgos
- Recruiting
Hospital San Pedro de Alcántara
Cáceres
- Recruiting
Hospital Universitario Reina Sofia
Córdoba
- Recruiting
Fundacion Jimenez Diaz
Madrid
- Recruiting
Hospital Universitario 12 de Octubre
Madrid
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid
- Recruiting
MD Anderson Cancer Center
Madrid
- Recruiting
Hospital Universitario Central de Asturias
Oviedo
- Recruiting
Hospital La Fe
Valencia
France10 sites, 10 recruiting
- Recruiting
Centre Hospitalier Universitaire Besancon
Besançon
- Recruiting
Hôpital Avicenne
Bobigny
- Recruiting
Centre Hospitalier Universitaire de Bordeaux - Hôpital Haut-Lévêque
Bordeaux
- Recruiting
Henri Mondor University Hospital
Créteil
- Recruiting
Centre Hospitalier Universitaire de Nice
Nice
- Recruiting
Saint-Antoine Hospital
Paris
- Recruiting
Saint-Louis Hospital
Paris
- Recruiting
Centre Hospitalier Universitaire Poitiers
Poitiers
- Recruiting
Centre Hospitalier Universitaire de Tours
Tours
- Recruiting
Gustave Roussy
Villejuif
Germany7 sites, 7 recruiting
- Recruiting
Klinikum Bremen-Mitte gGmbH
Bremen
- Recruiting
Klinikum Chemnitz gGmbH
Chemnitz
- Recruiting
Uniklinikum Leipzig
Leipzig
- Recruiting
University Hospital Schleswig Holstein Campus Lübeck
Lübeck
- Recruiting
Klinikum rechst der Isar, Technische Universität München
Munich
- Recruiting
Klinikum Oldenburg AöR
Oldenburg
- Recruiting
Uniklinikum Würzburg
Würzburg
Greece3 sites, 3 recruiting
- Recruiting
Evaggelismos Hospital, Dept. Hematology-Lymphoma and BMT Unit
Athens
- Recruiting
National and Kapodistrian University of Athens, General Hospital of Athens
Athens
- Recruiting
University of Patras
Pátrai
Netherlands3 sites, 3 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
- Recruiting
UMC Groningen
Groningen
- Recruiting
Radboud Universitair Medisch Centrum
Nijmegen
United Kingdom3 sites, 3 recruiting
- Recruiting
King's College Hospital
London
- Recruiting
University College London Hospitals
London
- Recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford
Denmark2 sites, 2 recruiting
- Recruiting
Aarhus University Hospital
Aarhus
- Recruiting
Odense University Hospital
Odense
Poland2 sites, 2 recruiting
- Recruiting
Institute of Hematology and Transfusion Medicine
Warsaw
- Recruiting
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital - Section for hematologi and coagulation
Gothenburg
About this study
Official title: Retrospective Study of Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Treated With Chemotherapy Agents
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).
- Being tested
- Chemotherapy
- Keywords
- BPDCN, Retrospective, STML-401-0521, ELZONRIS, Chemotherapy
- Medical subject headings
- Blastic Plasmacytoid Dendritic Cell Neoplasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Adult participants with BPDCN who have been treated with chemotherapy regimens (at a minimum) as first-line treatment from May 2016. Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Measured: Baseline through Month 18
Composite Complete Response
Measured: Baseline through Month 18
Number of Participants Bridged to Stem Cell Transplant
Measured: Baseline through Month 18
Duration of Response
Measured: Baseline through Month 18
Real-world Progression-free Survival
Measured: Baseline through Month 18
Overall Survival
Measured: Baseline through Month 18
Number of Participants with Treatment-emergent Adverse Events
Measured: Baseline through Month 18
Number of Participants Requiring Transfusions
Measured: Baseline through Month 18
Duration of Treatments Received and Hospitalization
Measured: Baseline through Month 18
Secondary outcomes (2)
Time to Next Treatment
Measured: Baseline through Month 26
Number of Different First-line Treatment Regimens and Sequences Received
Measured: Baseline through Month 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start17 Oct 2025
- Primary completionMay 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)Studies of the same condition, open and under way.
- More trials run by Stemline Therapeutics, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stemline Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Stemline Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785180
- Sponsor's protocol ID
- STML-401-0623
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Individual data sharing
- No: No plan to share data.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Treated With Chemotherapy Agents
- ClinicalTrials.gov ID
- NCT07785180
- Acronym / sponsor ID
- STML-401-0623
- Keywords
- BPDCN, Retrospective, STML-401-0521, ELZONRIS, Chemotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Stemline Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Oct 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | – | Drug: ChemotherapyAdult participants with BPDCN who have been treated with chemotherapy regimens (at a minimum) as first-line treatment from May 2016. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemotherapySeveral 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. | Drug | Chemotherapy |
Primary outcome
Objective Response Rate
Time frame: Baseline through Month 18
Composite Complete Response
Time frame: Baseline through Month 18
Number of Participants Bridged to Stem Cell Transplant
Time frame: Baseline through Month 18
Duration of Response
Time frame: Baseline through Month 18
Real-world Progression-free Survival
Time frame: Baseline through Month 18
Overall Survival
Time frame: Baseline through Month 18
Number of Participants with Treatment-emergent Adverse Events
Time frame: Baseline through Month 18
Number of Participants Requiring Transfusions
Time frame: Baseline through Month 18
Duration of Treatments Received and Hospitalization
Time frame: Baseline through Month 18
2 secondary outcomes
Time to Next Treatment
Time frame: Baseline through Month 26
Number of Different First-line Treatment Regimens and Sequences Received
Time frame: Baseline through Month 26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No. No plan to share data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director study director
Stemline Therapeutics, Inc.
67 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), run by Stemline Therapeutics, Inc. at 67 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in Italy, Spain, France, Germany, Greece and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stemline Trials (1-877-332-796, clinicaltrials@menarinistemline.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Baseline through Month 18). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.