Clinical trial NCT02364466: Cohort of Peripheral T Cell Lymphoma
Official title: Multicenter Prospective Cohort Study of Peripheral T Cell Lymphoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lymphoma, T-Cell, Peripheral
Febrile Neutropenia
Lead sponsor: Korea Cancer Center Hospital
Sponsor class: OTHER
Collaborators: name: Samsung Medical Center
name: Asan Medical Center
name: Keimyung University Dongsan Medical Center
name: Kosin University Gospel Hospital
name: Dankook University
name: Soonchunhyang University Hospital
name: Ajou University School of Medicine
name: Yeungnam University Hospital
name: Ulsan University Hospital
name: Inje University
name: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Hallym University Medical Center
name: Hanyang University Seoul Hospital
name: Seoul National University Hospital
name: Pusan National University Hospital
name: National Health Insurance Service Ilsan Hospital
name: Hanyang University
First posted: 2015-02-18
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Peripheral T-cell lymphoma 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

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Febrile neutropenia
timeFrame: 2 years after the last enrollment
Secondary outcomes:
measure: Infectious complication
timeFrame: 2 years after the last enrollment
Other outcomes:
Locations:
city: Cheonan
country: Korea, Republic of
facility: Dankook University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Guri
country: Korea, Republic of
facility: Hanyang University Guri Hospital
city: Ilsan
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Ilsan
country: Korea, Republic of
facility: National Health and Insurance Service Ilsan Hospital
city: Pusan
country: Korea, Republic of
facility: Kosin Universithy Gospel Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Choong Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Samsung Medical Center
name: Won Seog Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: