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NCT Number: NCT02859623

Descriptive Study of the Efficacy of Treatments for Blastic Dendritic Cell Neoplasm (BPDCN)

Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare disease characterized by an aggressive clinical behavior and a poor prognosis. It predominantly affects elderly males with an average age of 67 years at diagnosis and the affected organs are usually the skin, bone marrow, lymph nodes and the central nervous system. Patients with BPDCN have poor outcomes with median overall survival (OS) ranging in the largest series of patients from 8 to 12 months.

Patient care must be defined in this pathology. Despite 40%-90% complete remission (CR) rates after initial chemotherapy, relapses are almost inevitable.

The investigators have developed a national network to collect clinical and biological data of French patients diagnosed with BPDCN.

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Key information

Conditions

Blastic Plasmacytoid Dendritic Cell Neoplasm Hematologic Diseases Hematologic Neoplasms Hematological Malignancies Hemic and Lymphatic Diseases Histiocytic Disorders, Malignant Leukemia Lymphoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with blastic plasmacytoid dendritic cell neoplasm (BPDCN) from January 2000 to June 2013 in France.
  • Diagnosis should be established by hematology laboratory of French blood Agency of Bourgogne Franche-Comté and/or by anatomopathological analysis (realized in local centres or by Tony Petrella at Dijon University Hospital) according to phenotypic and anatomopathological criteria published in the literature.

Exclusion criteria

  • No exclusion criteria

Treatment and study plan

Primary outcomes

  1. description of the efficacy of treatments for BPDCN

    Time frame: from the diagnosis to death or until June 2013, date of end of data collection

    Measurement of the overall survival for all patients from the date of diagnostic until death or end of data collection

Secondary outcomes

  1. description of clinical profiles of patients

    Time frame: from the diagnosis to death or until June 2013, end of data collection

    presence of cutaneous lesions

  2. description of biological profiles of patients

    Time frame: from the diagnosis to death or until June 2013, end of data collection

    immunophenotyping profile

  3. complete remission rate

    Time frame: from the diagnosis to death or until June 2013, end of data collection

  4. mean duration of the first remission

    Time frame: from the diagnosis to death or until June 2013, end of data collection

  5. survival without events

    Time frame: from the diagnosis to death or until June 2013, end of data collection

  6. non-responders rate

    Time frame: from the diagnosis to death or until June 2013, end of data collection

  7. time interval between two treatments

    Time frame: from the diagnosis to death or until June 2013, end of data collection

  8. mortality without relapse

    Time frame: from the diagnosis to death or until June 2013, end of data collection

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

Descriptive Study of the Efficacy of Treatments for Blastic Dendritic Cell Neoplasm (BPDCN): a Retrospective Study of Patients Diagnosed in France From 2000 to 2013

Acronym: LpDC

Important dates

Study start
2014
Primary completion
2015
First posted
Aug 9, 2016
Registry last updated
Aug 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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