Blastic Plasmacytoid Dendritic Cell Neoplasm in Korean Population.
NCT ID: NCT03974971
Last Updated: 2020-09-03
Study Results
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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COMPLETED
36 participants
OBSERVATIONAL
2019-04-30
2020-02-29
Brief Summary
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Detailed Description
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Skin in¬volvement is a predominant clinical feature of BPDCN ranging in appearance from small bruise-like areas to patches, nodules, and ulcerated masses, but lymphadenopathy, splenomegaly, hepatomegaly are also commonly observed. There is no definite treatment guideline for BPDCN. Retrospective studies including acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL)/lymphoma-like chemotherapy for management of BPDCN reported 53-89% of high complete remission rates but an eventual very poor overall survival of 12-23 months, with a preponderance of ALL/lymphoma- over AML-like treatment5. Recently, targeted therapy with SL401, an IL-3 fusion protein which binds to CD123, is promising and the results of the clinical trial will be unveiled in the near future6.
Although several retrospective and small case series has been published so far7,8, there is still no multicenter study on BPDCN classified after 2008 WHO classification in Asian population. This study aims to retrospectively collect data of BPDCN patients from centers participating the Consortium for improving survival of lymphoma (CISL) and analyze the clinical features and treatment outcomes in this rare type of hematologic malignancy.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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BPDCN diagnosis group
By review medical records Enroll patients diagnosed with BPDCN from January 1, 2000 to October 31, 2018
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Pathologically confirmed diagnosis by tissue or bone marrow at each center with
* Blastic plasmacytoid dendritic cell neoplasm
* Blastic NK-cell lymphoma
* Agranular CD4+ natural killer cell leukaemia
* Blastic natural killer leukaemia/lymphoma
* Agranular CD4+CD56+ haematodermic neoplasm/tumour
3. Antigen expression of CD4 and/or CD56 coupled with at least one plasmacytoid dendritic cell-associated antigen among CD123, TCL1, CD2AP and BDCA2/CD303
Exclusion Criteria
2. Acute lymphoblastic leukemia
3. Mixed phenotype acute leukemia
4. Any type of B- or T-/NK/T-cell lymphomas
5. Expression of lineage-specific markers for B cells (CD20, CD79a) T cells (CD3) Myeloid cells (myeloperoxidase) Monocytes (CD11c, CD163, lysozyme). CD34
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Kim, Seok Jin
Principal Investigator
Principal Investigators
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Seokjin Kim, M.D., PhD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Samsung medical center
Seoul, Gang Nam, South Korea
Countries
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Other Identifiers
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2019-02-035
Identifier Type: -
Identifier Source: org_study_id
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