ClinicalTrials.gg
RecruitingNCT05430971Updated Jun 5, 2026

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) International Registry

An observational study in Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), sponsored by Immune Oncology Research Institute. Recruiting at 22 sites in 15 countries. Per ClinicalTrials.gov, last updated 2026-06-05.

Sponsored by Immune Oncology Research Institute · Observational

From the registry’s dates

  • Started Jul 2022; still recruiting 4 years 4 months later.
Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
200
Sex
All
01

Study summary

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) is a very rare hematologic malignancy. Despite recent advances, at present there is no consensus on the optimal treatment of BPDCN. The optimal therapy of disease remains to be determined, and due to the rarity of cases, there is a need for international collaboration to collect data on BPDCN clinical presentations, diagnostics, treatment regimens and outcomes. Therefore, the objectives of this study are: (1) to build a large database of patients with BPDCN, (2) to investigate the characteristics and outcome of the disease with different treatment regimens, (3) to evaluate prognostic factors, and (4) to generate data-based prospective treatment recommendations.

Read the detailed description

Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare hematologic malignancy. In 2008, it was recognized by the WHO as a distinct entity and separately listed in the group of acute myeloid leukemias and related precursor neoplasms.

The final diagnosis of BPDCN relies on a compatible immunophenotype. The triple positive CD4+CD56+CD123+ phenotype associated with negativity for lineage-specific markers is a minimum requirement for defining BPDCN. The highly specific marker BDCA2/CD303, as well as other plasmacytoid dendritic cell-associated antigens (e.g. TCL1 and CD2AP), might be of great support to exclude potential mimickers of BPDCN (acute myeloid and monocytic leukemias, precursor lymphoblastic T-cell leukemia/lymphomas and T- and NK/T cell lymphomas.

At present, there is no consensus on the optimal treatment of BPDCN. The majority of patients receive multi-agent chemotherapy with AML or ALL treatment regimens, while a few patients undergo allogeneic haematopoietic stem cell transplantation (HSCT). In recent years, different novel and innovative therapies are in development to target surface molecules in BPDCN. The patients are still in need of better treatments and the optimal therapy of disease remains to be determined.

This is a multicenter, international prospective and retrospective registry with the aim of collecting data of patients with a diagnosis of BPDCN globally.

Patients will be recruited directly by the national study groups / participating centers.

Participating centers will collect and verify informed consent of all prospective patients enrolled at their center.

The following data will be collected through questionnaires:

  1. Patient characteristics
  2. BPDCN characteristics
  3. Treatment details
  4. Outcomes
  5. Cause of death
  6. End of data collection

Quality control and data management will be conducted by the Immune Oncology Research Institute.

02

Conditions studied

  • Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
03

In context

Blastic Plasmacytoid Dendritic Cell Neoplasm

45 studies on the registry are indexed under Blastic Plasmacytoid Dendritic Cell Neoplasm; 15 are open to participants now.

Browse Blastic Plasmacytoid Dendritic Cell Neoplasm studies →

Lead sponsor

Immune Oncology Research Institute is the lead sponsor of 6 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients with BPDCN diagnosed since 01.01.2010

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of BPDCN
  • Signed form for prospective patients

Exclusion criteria

Exclusion Criteria:

-

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Other
Enrollment
200 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Overall survival

    Time from diagnosis to death

    Time frame: 5 years

Secondary outcomes

  1. Complete remission rate

    The proportion of patients with complete remission

    Time frame: 5 years

  2. Mean duration of the first remission

    Time from first remission to disease progression or death

    Time frame: 5 years

  3. Event-free survival

    Time from diagnosis to occurrence of a complication

    Time frame: 5 years

07

Study locations

22 of 22 sites recruiting
  • Sylvester Comprehensive Cancer Center, University of Miami
    Miami, Florida 33136, United States
    Recruiting
  • Moffitt Cancer Center
    Tampa, Florida 33612, United States
    Recruiting
  • Seattle Children's Cancer and Blood Disorders Center
    Seattle, Washington 98145, United States
    Recruiting
  • Hematology Center named after prof. R. Yeolyan
    Yerevan, 0014, Armenia
    Recruiting
    • Astghik Voskanyan, MD · Contactastghikvos@gmail.com · +374 10 283800
    • Gevorg Tamamyan, PhD · Contactgevorgtamamyan@gmail.com · +374 10 283800
    • Shushan Hovsepyan, MD · Sub investigator
    • Nerses Ghahramanyan, MD · Sub investigator
  • University of Calgary
    Calgary, Alberta T2N 1N4, Canada
    Recruiting
  • Children's Hospital of Eastern Ontario, University of Ottawa
    Ottawa, Ontario K1H 8L1, Canada
    Recruiting
  • Cyprus Society of Haematology
    Nicosia, 2019, Cyprus
    Recruiting
  • Oncology Center, Mansoura University Faculty of Medicine
    Al Mansurah, 7650030, Egypt
    Recruiting
  • M. Iashvili Children's Central Hospital
    Tbilisi, 0159, Georgia
    Recruiting
  • Department of Medical Oncology, Dr. B.R.A Institute Rotary Cancer Hospital, All India Institute of Medical Sciences
    New Delhi, 110029, India
    Recruiting
    • Sameer Bakhshi, MBBS, MD, DM · Contact
  • Pediatric Hematology Oncology, Children's Welfare Teaching Hospital, Medical City, College of Medicine, University of Baghdad
    Baghdad, 61023, Iraq
    Recruiting
  • University of Perugia - Azienda Ospedaliera Perugia
    Perugia, 06129, Italy
    Recruiting
  • Department of Biomedicine and Prevention, University of Rome Tor Vergata
    Roma, 00133, Italy
    Recruiting
  • King Hussein Cancer Center (KHCC)
    Amman, 11941, Jordan
    Recruiting
  • Department of hematology, Kuwait Cancer Control Center
    Kuwait City, 42262, Kuwait
    Recruiting
    • Ahmad Alhuraiji, MD, MRCP(UK) · Contact+965 24849100
  • Fundeni Clinical Institute, Department of Acute Leukemia
    Bucharest, 022328, Romania
    Recruiting
    • Maria Camelia Stancioaica, MD · Contact+40740959904
    • Daniel Coriu, MD, PhD · Contact
  • China Medical University Children's Hospital
    Taichung, 40447, Taiwan
    Recruiting
  • Turkish Pediatric Cancer Registry
    Ankara, 06690, Turkey (Türkiye)
    Recruiting
  • Istanbul University, Oncology Institute
    Istanbul, 34093, Turkey (Türkiye)
    Recruiting
  • University of Health Sciences, Umraniye Research and Education Hospital, Pediatric Hematology and Oncology Department, Pediatric Bone Marrow Transplantation Unit
    Istanbul, 34766, Turkey (Türkiye)
    Recruiting
  • Broomfield Hospital, Haematology Mid and South Essex University Hospitals Group
    Chelmsford, Essex CM1 7ET, United Kingdom
    Recruiting
  • United Lincolnshire Teaching Hospital NHS Trust
    Lincoln, Lincolnshire LN2 5QY, United Kingdom
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05430971
Lead sponsor
Immune Oncology Research Institute
Responsible party
Sponsor
First posted
Jun 24, 2022
Start date
Jul 1, 2022
Primary completion
Jul 2032 (estimated)
Completion
Jul 2032 (estimated)
Last update
Jun 5, 2026

Study contacts

Astghik Voskanyan, MD
Contact
astghikvos@gmail.com
+374 10 28 38 00
Davit Melkonyan
Contact
davit.melkonyan@immonc.org
+374 10 28 38 00
Astghik Voskanyan, MD
principal investigator · Immune Oncology Research Institute, Yerevan, Armenia
Gevorg Tamamyan, MD, PhD, DSc
study director · Immune Oncology Research Institute, Yerevan, Armenia

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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