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

Hematological Malignancies Clinical Trial

— LpDC  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02859623
• Other study ID #: LpDC
• Status: Completed
• Phase: N/A
• First received: July 21, 2016
• Last updated: August 4, 2016
• Start date: January 2014

Study information

• Verified date: July 2016
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Blastic Plasmacytoid Dendritic Cell Neoplasm
• Hematological Malignancies
• Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	description of the efficacy of treatments for BPDCN	Measurement of the overall survival for all patients from the date of diagnostic until death or end of data collection	from the diagnosis to death or until June 2013, date of end of data collection	No
Secondary	description of clinical profiles of patients	presence of cutaneous lesions	from the diagnosis to death or until June 2013, end of data collection	No
Secondary	description of biological profiles of patients	immunophenotyping profile	from the diagnosis to death or until June 2013, end of data collection	No
Secondary	complete remission rate		from the diagnosis to death or until June 2013, end of data collection	No
Secondary	mean duration of the first remission		from the diagnosis to death or until June 2013, end of data collection	No
Secondary	survival without events		from the diagnosis to death or until June 2013, end of data collection	No
Secondary	non-responders rate		from the diagnosis to death or until June 2013, end of data collection	No
Secondary	time interval between two treatments		from the diagnosis to death or until June 2013, end of data collection	No
Secondary	mortality without relapse		from the diagnosis to death or until June 2013, end of data collection	No