Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) International Registry

NCT ID: NCT05430971

Last Updated: 2024-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2032-07-31

Brief Summary

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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

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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.

Conditions

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Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Immune Oncology Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Astghik Voskanyan, MD

Role: PRINCIPAL_INVESTIGATOR

Immune Oncology Research Institute, Yerevan, Armenia

Gevorg Tamamyan, MD, PhD, DSc

Role: STUDY_DIRECTOR

Immune Oncology Research Institute, Yerevan, Armenia

Locations

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Sylvester Comprehensive Cancer Center, University of Miami

Miami, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

Seattle Children's Cancer and Blood Disorders Center

Seattle, Washington, United States

Site Status RECRUITING

Hematology Center named after prof. R. Yeolyan

Yerevan, Yerevan, Armenia

Site Status RECRUITING

University of Calgary

Calgary, Alberta, Canada

Site Status RECRUITING

Children's Hospital of Eastern Ontario, University of Ottawa

Ottawa, Ontario, Canada

Site Status RECRUITING

Cyprus Society of Haematology

Nicosia, , Cyprus

Site Status RECRUITING

Oncology Center, Mansoura University Faculty of Medicine

Al Mansurah, , Egypt

Site Status RECRUITING

M. Iashvili Children's Central Hospital

Tbilisi, , Georgia

Site Status RECRUITING

Department of Medical Oncology, Dr. B.R.A Institute Rotary Cancer Hospital, All India Institute of Medical Sciences

New Delhi, , India

Site Status RECRUITING

Pediatric Hematology Oncology, Children's Welfare Teaching Hospital, Medical City, College of Medicine, University of Baghdad

Baghdad, , Iraq

Site Status RECRUITING

University of Perugia - Azienda Ospedaliera Perugia

Perugia, , Italy

Site Status RECRUITING

Department of Biomedicine and Prevention, University of Rome Tor Vergata

Roma, , Italy

Site Status RECRUITING

Department of hematology, Kuwait Cancer Control Center

Kuwait City, , Kuwait

Site Status RECRUITING

Fundeni Clinical Institute, Department of Acute Leukemia

Bucharest, , Romania

Site Status RECRUITING

China Medical University Children's Hospital

Taichung, , Taiwan

Site Status RECRUITING

Turkish Pediatric Cancer Registry

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Istanbul University, Oncology Institute

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

University of Health Sciences, Umraniye Research and Education Hospital, Pediatric Hematology and Oncology Department, Pediatric Bone Marrow Transplantation Unit

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Broomfield Hospital, Haematology Mid and South Essex University Hospitals Group

Chelmsford, Essex, United Kingdom

Site Status RECRUITING

Countries

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United States Armenia Canada Cyprus Egypt Georgia India Iraq Italy Kuwait Romania Taiwan Turkey (Türkiye) United Kingdom

Central Contacts

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Astghik Voskanyan, MD

Role: CONTACT

+374 10 28 38 00

Karen Bedirian, MPH

Role: CONTACT

+374 10 28 38 00

Facility Contacts

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Dickran Kazandjian, MD

Role: primary

Alvaro Alencar, MD

Role: backup

Rami Komrokji, MD

Role: primary

Adam Lamble, MD

Role: primary

Astghik Voskanyan, MD

Role: primary

+374 10 283800

Gevorg Tamamyan, PhD

Role: backup

+374 10 283800

Shushan Hovsepyan, MD

Role: backup

Nerses Ghahramanyan, MD

Role: backup

Carolyn Owen, MD

Role: primary

Consolato Sergi, MD, PhD

Role: primary

Michalis Michael, MD

Role: primary

Shaimaa El-Ashwah, MD

Role: primary

Nino Totogashvili, MD

Role: primary

Sameer Bakhshi, MBBS, MD, DM

Role: primary

Mazin Faisal Al-Jadiry, MD

Role: primary

Hasanein Habeeb Ghali, MD

Role: backup

Maria Paola Martelli, MD, PhD

Role: primary

Maria Teresa Voso, MD

Role: primary

Ahmad Alhuraiji, MD, MRCP(UK)

Role: primary

+965 24849100 ext. 24002

Maria Camelia Stancioaica, MD

Role: primary

+40740959904

Daniel Coriu, MD, PhD

Role: backup

Min-Yu Su, MD

Role: primary

Ching-Tien Peng, MD

Role: backup

Tezer Kutluk, MD, PhD

Role: primary

Rejin Kebudi, MD

Role: primary

Funda Tekkesin, MD

Role: primary

Pavel P Kotoucek, PhD, FRCPath

Role: primary

Other Identifiers

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IMMONC0002

Identifier Type: -

Identifier Source: org_study_id

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