Cohort of Peripheral T Cell Lymphoma

Febrile Neutropenia Clinical Trial

Official title:

Multicenter Prospective Cohort Study of Peripheral T Cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02364466
• Other study ID #: Giraffe-T
• Status: Recruiting
• Phase: N/A
• First received: February 2, 2015
• Last updated: February 10, 2015
• Start date: January 2015
• Est. completion date: December 2019

Study information

• Verified date: February 2015
• Source: Korea Cancer Center Hospital
• Contact: Dong-Yeop Shin, M.D.
• Phone: +82-2-970-1246
• Email: baramg[@]hanmail.net
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. 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

2. Scheduled to receive chemotherapy of curative intent

3. 19 years old or over

4. Expected survival is more than 6 months

5. Informed consent

Exclusion Criteria:

1. Other histology than those described above

• Extranodal NK/T cell lymphoma

• Other than peripheral T cell lymphoma

2. Other combined malignancy

3. Previous history of chemotherapy or radiation therapy

4. No informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Febrile Neutropenia
• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Neutropenia

Locations

Country	Name	City	State
Korea, Republic of	Dankook University Hospital	Cheonan
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu
Korea, Republic of	Yeungnam University Hospital	Daegu
Korea, Republic of	Hanyang University Guri Hospital	Guri
Korea, Republic of	Inje University Ilsan Paik Hospital	Ilsan
Korea, Republic of	National Health and Insurance Service Ilsan Hospital	Ilsan
Korea, Republic of	Kosin Universithy Gospel Hospital	Pusan
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Choong Ang University Hospital	Seoul
Korea, Republic of	Hallym University Hospital	Seoul
Korea, Republic of	Hanyang University Hospital	Seoul
Korea, Republic of	Korea Cancer Center Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Soonchunhyang University Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (18)

Lead Sponsor

Collaborator

Korea Cancer Center Hospital

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

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Febrile neutropenia	Incidence and severity of febrile neutropenia	2 years after the last enrollment	No
Secondary	Infectious complication	incidence, severity, microbiology of infection	2 years after the last enrollment	No