Cohort of Peripheral T Cell Lymphoma

Sponsor

Korea Cancer Center Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02364466

Collaborator

Samsung Medical Center (Other), Asan Medical Center (Other), Keimyung University Dongsan Medical Center (Other), Kosin University Gospel Hospital (Other), Dankook University (Other), Soonchunhyang University Hospital (Other), Ajou University School of Medicine (Other), Yeungnam University Hospital (Other), Ulsan University Hospital (Other), Inje University (Other), Chung-Ang University Hosptial, Chung-Ang University College of Medicine (Other), Hallym University Medical Center (Other), Hanyang University Seoul Hospital (Other), Seoul National University Hospital (Other), Pusan National University Hospital (Other), National Health Insurance Service Ilsan Hospital (Other), Hanyang University (Other)

200

Enrollment

Locations

Duration (Months)

11.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prospective, observational cohort study of peripheral T cell lymphoma. Purpose is to investigate the complication including febrile neutropenia in the era of pegylated G-CSF prophylaxis.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, T-Cell, Peripheral Febrile Neutropenia

Detailed Description

Prospective evaluation of frequencies of febrile neutropenia or infectious complications in a homogeneous population of patients with peripheral T cell lymphoma

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Multicenter Prospective Cohort Study of Peripheral T Cell Lymphoma

Study Start Date :

Jan 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Outcome Measures

Primary Outcome Measures

Febrile neutropenia [2 years after the last enrollment]
Incidence and severity of febrile neutropenia

Secondary Outcome Measures

Infectious complication [2 years after the last enrollment]
incidence, severity, microbiology of infection

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Treatment naive peripheral T cell lymphoma

Subtypes are as followings:

Anaplastic large cell lymphoma angioimmunoblastic T cell lymphoma Peripheral T cell lymphoma-NOS Enteropathy-associated T cell lymphoma Hepatosplenic T-cell lymphoma Subcutaneous panniculitis-like T-cell lymphoma Primary cutaneous gamma-delta T-cell lymphoma Primary cutaneous CD8+ aggressive epidermotropic lymphoma

Scheduled to receive chemotherapy of curative intent
19 years old or over
Expected survival is more than 6 months
Informed consent

Exclusion Criteria:

Other histology than those described above

Extranodal NK/T cell lymphoma
Other than peripheral T cell lymphoma

Other combined malignancy
Previous history of chemotherapy or radiation therapy
No informed consent

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Dankook University Hospital	Cheonan	Korea, Republic of
2	Keimyung University Dongsan Hospital	Daegu	Korea, Republic of
3	Yeungnam University Hospital	Daegu	Korea, Republic of
4	Hanyang University Guri Hospital	Guri	Korea, Republic of
5	Inje University Ilsan Paik Hospital	Ilsan	Korea, Republic of
6	National Health and Insurance Service Ilsan Hospital	Ilsan	Korea, Republic of
7	Kosin Universithy Gospel Hospital	Pusan	Korea, Republic of
8	Pusan National University Hospital	Pusan	Korea, Republic of
9	Korea Cancer Center Hospital	Seoul	Korea, Republic of	139-706
10	Asan Medical Center	Seoul	Korea, Republic of
11	Choong Ang University Hospital	Seoul	Korea, Republic of
12	Hallym University Hospital	Seoul	Korea, Republic of
13	Hanyang University Hospital	Seoul	Korea, Republic of
14	Samsung Medical Center	Seoul	Korea, Republic of
15	Seoul National University Hospital	Seoul	Korea, Republic of
16	Soonchunhyang University Hospital	Seoul	Korea, Republic of
17	Ajou University Hospital	Suwon	Korea, Republic of
18	Ulsan University Hospital	Ulsan	Korea, Republic of