Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) International Registry

February 12, 2026 updated by: Immune Oncology Research Institute
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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Armenia
      • Yerevan, Armenia, 0014
        • Recruiting
        • Hematology Center named after prof. R. Yeolyan
        • Contact:
        • Sub-Investigator:
          • Shushan Hovsepyan, MD
        • Sub-Investigator:
          • Nerses Ghahramanyan, MD
        • Contact:
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L1
        • Recruiting
        • Children's Hospital of Eastern Ontario, University of Ottawa
        • Contact:
  • Cyprus
      • Nicosia, Cyprus, 2019
  • Egypt
      • Al Mansurah, Egypt, 7650030
        • Recruiting
        • Oncology Center, Mansoura University Faculty of Medicine
        • Contact:
  • Georgia
      • Tbilisi, Georgia, 0159
  • India
      • New Delhi, India, 110029
        • Recruiting
        • Department of Medical Oncology, Dr. B.R.A Institute Rotary Cancer Hospital, All India Institute of Medical Sciences
        • Contact:
          • Sameer Bakhshi, MBBS, MD, DM
  • Iraq
      • Baghdad, Iraq, 61023
        • Recruiting
        • Pediatric Hematology Oncology, Children's Welfare Teaching Hospital, Medical City, College of Medicine, University of Baghdad
        • Contact:
        • Contact:
  • Italy
      • Perugia, Italy, 06129
        • Recruiting
        • University of Perugia - Azienda Ospedaliera Perugia
        • Contact:
      • Roma, Italy, 00133
        • Recruiting
        • Department of Biomedicine and Prevention, University of Rome Tor Vergata
        • Contact:
  • Kuwait
      • Kuwait City, Kuwait, 42262
        • Recruiting
        • Department of hematology, Kuwait Cancer Control Center
        • Contact:
          • Ahmad Alhuraiji, MD, MRCP(UK)
          • Phone Number: 24002 +965 24849100
  • Romania
      • Bucharest, Romania, 022328
        • Recruiting
        • Fundeni Clinical Institute, Department of Acute Leukemia
        • Contact:
          • Maria Camelia Stancioaica, MD
          • Phone Number: +40740959904
        • Contact:
          • Daniel Coriu, MD, PhD
  • Taiwan
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University Children's Hospital
        • Contact:
        • Contact:
          • Ching-Tien Peng, MD
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06690
        • Recruiting
        • Turkish Pediatric Cancer Registry
        • Contact:
      • Istanbul, Turkey (Türkiye), 34093
        • Recruiting
        • Istanbul University, Oncology Institute
        • Contact:
      • Istanbul, Turkey (Türkiye), 34766
        • Recruiting
        • University of Health Sciences, Umraniye Research and Education Hospital, Pediatric Hematology and Oncology Department, Pediatric Bone Marrow Transplantation Unit
        • Contact:
  • United Kingdom
    • Essex
      • Chelmsford, Essex, United Kingdom, CM1 7ET
        • Recruiting
        • Broomfield Hospital, Haematology Mid and South Essex University Hospitals Group
        • Contact:
  • United States
    • Florida
      • Miami, Florida, United States, 33136
      • Tampa, Florida, United States, 33612
    • Washington
      • Seattle, Washington, United States, 98145

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients with BPDCN diagnosed since 01.01.2010

Description

Inclusion Criteria:

  • Diagnosis of BPDCN
  • Signed informed consent form for prospective patients

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
Time from diagnosis to death
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete remission rate
Time Frame: 5 years
The proportion of patients with complete remission
5 years
Mean duration of the first remission
Time Frame: 5 years
Time from first remission to disease progression or death
5 years
Event-free survival
Time Frame: 5 years
Time from diagnosis to occurrence of a complication
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immune Oncology Research Institute

Investigators

  • Principal Investigator: Astghik Voskanyan, MD, Immune Oncology Research Institute, Yerevan, Armenia
  • Study Director: Gevorg Tamamyan, MD, PhD, DSc, Immune Oncology Research Institute, Yerevan, Armenia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Estimated)

July 1, 2032

Study Completion (Estimated)

July 1, 2032

Study Registration Dates

First Submitted

June 21, 2022

First Submitted That Met QC Criteria

June 21, 2022

First Posted (Actual)

June 24, 2022

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMMONC0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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