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

Completed

• Conditions: Hematological Malignancies; Blastic Plasmacytoid Dendritic Cell Neoplasm

• Registration Number: NCT02859623
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-05
• Status Verified: 2016-07
• Study First Submitted: 2016-07-21
• Study First Submitted QC: 2016-08-04
• Last Update Submitted: 2016-08-04
• Study First Posted: 2016-08-09
• Last Update Posted: 2016-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
description of the efficacy of treatments for BPDCN	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 Outcome Measures

Name	Time	Method
description of clinical profiles of patients	from the diagnosis to death or until June 2013, end of data collection	presence of cutaneous lesions
mean duration of the first remission	from the diagnosis to death or until June 2013, end of data collection
complete remission rate	from the diagnosis to death or until June 2013, end of data collection
non-responders rate	from the diagnosis to death or until June 2013, end of data collection
description of biological profiles of patients	from the diagnosis to death or until June 2013, end of data collection	immunophenotyping profile
survival without events	from the diagnosis to death or until June 2013, end of data collection
time interval between two treatments	from the diagnosis to death or until June 2013, end of data collection
mortality without relapse	from the diagnosis to death or until June 2013, end of data collection