Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)NCT05430971
Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) International Registry
An observational study of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), run by Immune Oncology Research Institute at 22 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
- How many people
- 200 participants
- Where
- 22 sitesin 15 countries
- Study dates
- 1 Jul 2022to Jul 2032
- How long will I take part?
- 5 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with BPDCN diagnosed since 01.01.2010
Who may be able to join
- Diagnosis of BPDCN
- Signed informed consent form for prospective patients
Who cannot join
- -
Trial locations and contacts
22 sites in 15 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 15 countries
United States3 sites, 3 recruiting
- Recruiting
Sylvester Comprehensive Cancer Center, University of Miami
Miami, Florida, 33136
Dickran Kazandjian, MD, dkazandjian@miami.edu
Alvaro Alencar, MD, aalencar@med.miami.edu
- Recruiting
Seattle Children's Cancer and Blood Disorders Center
Seattle, Washington, 98145
Adam Lamble, MD, adam.lamble@seattlechildrens.org
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Rami Komrokji, MD, rami.komrokji@moffitt.org
Turkey (Türkiye)3 sites, 3 recruiting
- Recruiting
Turkish Pediatric Cancer Registry
Ankara, 06690
Tezer Kutluk, MD, PhD, tezerkutluk@gmail.com
- Recruiting
Istanbul University, Oncology Institute
Istanbul, 34093
Rejin Kebudi, MD, rejinkebudi@yahoo.com
- Recruiting
University of Health Sciences, Umraniye Research and Education Hospital, Pediatric Hematology and Oncology Department, Pediatric Bone Marrow Transplantation Unit
Istanbul, 34766
Funda Tekkesin, MD, tekkesinfunda@gmail.com
Canada2 sites, 2 recruiting
- Recruiting
University of Calgary
Calgary, Alberta, T2N 1N4
Carolyn Owen, MD, carolyn.owen@ahs.ca
- Recruiting
Children's Hospital of Eastern Ontario, University of Ottawa
Ottawa, Ontario, K1H 8L1
Consolato Sergi, MD, PhD, csergi@cheo.on.ca
Italy2 sites, 2 recruiting
- Recruiting
University of Perugia - Azienda Ospedaliera Perugia
Perugia, 06129
Maria Paola Martelli, MD, PhD, maria.martelli@unipg.it
- Recruiting
Department of Biomedicine and Prevention, University of Rome Tor Vergata
Roma, 00133
Maria Teresa Voso, MD, voso@med.uniroma2.it
United Kingdom2 sites, 2 recruiting
- Recruiting
Broomfield Hospital, Haematology Mid and South Essex University Hospitals Group
Chelmsford, Essex, CM1 7ET
Pavel P Kotoucek, PhD, FRCPath, pavel.kotoucek@nhs.net
- Recruiting
United Lincolnshire Teaching Hospital NHS Trust
Lincoln, Lincolnshire, LN2 5QY
Marios Tsoutsoukis, MD, marios.tsoutsoukis@nhs.net
Armenia1 site, 1 recruiting
- Recruiting
Hematology Center named after prof. R. Yeolyan
Yerevan, 0014
Astghik Voskanyan, MD, +374 10 283800, astghikvos@gmail.com
Gevorg Tamamyan, PhD, +374 10 283800, gevorgtamamyan@gmail.com
Cyprus1 site, 1 recruiting
- Recruiting
Cyprus Society of Haematology
Nicosia, 2019
Michalis Michael, MD, mixalis.maxail@gmail.com
Egypt1 site, 1 recruiting
- Recruiting
Oncology Center, Mansoura University Faculty of Medicine
Al Mansurah, 7650030
Shaimaa El-Ashwah, MD, shaimaasaber@mans.edu.eg
Georgia1 site, 1 recruiting
- Recruiting
M. Iashvili Children's Central Hospital
Tbilisi, 0159
Nino Totogashvili, MD, nino_totogashvili@yahoo.com
India1 site, 1 recruiting
- Recruiting
Department of Medical Oncology, Dr. B.R.A Institute Rotary Cancer Hospital, All India Institute of Medical Sciences
New Delhi, 110029
Sameer Bakhshi, MBBS, MD, DM
Iraq1 site, 1 recruiting
- Recruiting
Pediatric Hematology Oncology, Children's Welfare Teaching Hospital, Medical City, College of Medicine, University of Baghdad
Baghdad, 61023
Mazin Faisal Al-Jadiry, MD, mazinaljadiry@yahoo.com
Hasanein Habeeb Ghali, MD, hasaneinghali@gmail.com
Jordan1 site, 1 recruiting
- Recruiting
King Hussein Cancer Center (KHCC)
Amman, 11941
Zaid Abdel Rahman, MD, za.11040@khcc.jo
Kuwait1 site, 1 recruiting
- Recruiting
Department of hematology, Kuwait Cancer Control Center
Kuwait City, 42262
Ahmad Alhuraiji, MD, MRCP(UK), +965 24849100 ext. 24002
Romania1 site, 1 recruiting
- Recruiting
Fundeni Clinical Institute, Department of Acute Leukemia
Bucharest, 022328
Maria Camelia Stancioaica, MD, +40740959904
Daniel Coriu, MD, PhD
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Children's Hospital
Taichung, 40447
Min-Yu Su, MD, 035515@tool.caaumed.org.tw
Ching-Tien Peng, MD
About this study
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:
- Patient characteristics
- BPDCN characteristics
- Treatment details
- Outcomes
- Cause of death
- End of data collection
Quality control and data management will be conducted by the Immune Oncology Research Institute.
- Medical subject headings
- Blastic Plasmacytoid Dendritic Cell Neoplasm
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Time from diagnosis to death
Measured: 5 years
Secondary outcomes (3)
Complete remission rate
The proportion of patients with complete remission
Measured: 5 years
Mean duration of the first remission
Time from first remission to disease progression or death
Measured: 5 years
Event-free survival
Time from diagnosis to occurrence of a complication
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 Jul 2022
- Primary completionJul 2032 (estimated)
- Study completionJul 2032 (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.
- 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
- Case only
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Immune Oncology Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Astghik Voskanyan, MD, Principal investigator, Immune Oncology Research Institute, Yerevan, ArmeniaGevorg Tamamyan, MD, PhD, DSc, Study director, Immune Oncology Research Institute, Yerevan, Armenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430971
- Sponsor's protocol ID
- IMMONC0002
- Status last verified
- Feb 2026
- First submitted
- 21 Jun 2022
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) International Registry
- ClinicalTrials.gov ID
- NCT05430971
- Acronym / sponsor ID
- IMMONC0002
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Immune Oncology Research InstituteUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- Jul 2032 (estimated)
- Study completion
- Jul 2032 (estimated)
- First posted
- 24 Jun 2022 (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.
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.
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:
- Patient characteristics
- BPDCN characteristics
- Treatment details
- Outcomes
- Cause of death
- End of data collection
Quality control and data management will be conducted by the Immune Oncology Research Institute.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with BPDCN diagnosed since 01.01.2010
Key inclusion criteria (2 listed)
- Diagnosis of BPDCN
- Signed informed consent form for prospective patients
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 5 years
Time from diagnosis to death
3 secondary outcomes
Complete remission rate
Time frame: 5 years
Mean duration of the first remission
Time frame: 5 years
Event-free survival
Time frame: 5 years
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 5 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
RecruitingPhase 1/2
CARCIK CD123/33 for Refractory/Relapsed AML and BPDCN in Children and Adults
AML (Acute Myeloid Leukemia), BPDCN
RecruitingObservational study
A Non-interventional Study of Participants With BPDCN Treated With Chemotherapy
Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
RecruitingPhase 2
Venetoclax, SL-401, and Chemotherapy for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm
Blastic Plasmacytoid Dendritic Cell Neoplasm
Active, not recruitingEarly Phase 1
CART123 T Cells in Relapsed or Refractory CD123+ Hematologic Malignancies: A Dose Escalation Phase I Trial
Leukemia, Myeloid, Acute(AML), Precursor Cell Lymphoblastic Leukemia-Lymphoma
Active, not recruitingPhase 1/2
Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN
Blastic Plasmacytoid Dendritic Cell Neoplasm, Myeloproliferative Neoplasm
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.
Astghik Voskanyan, MD principal investigator
Immune Oncology Research Institute, Yerevan, Armenia
Gevorg Tamamyan, MD, PhD, DSc study director
Immune Oncology Research Institute, Yerevan, Armenia
22 sites in 15 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 Immune Oncology Research Institute at 22 sites in 15 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 2 inclusion and 1 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 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Turkey (Türkiye), Canada, Italy, United Kingdom and 10 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 Astghik Voskanyan, MD (+374 10 28 38 00, astghikvos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 years). 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 5 Jun 2026.