Cohort of Peripheral T Cell Lymphoma

Multicenter Prospective Cohort Study of Peripheral T Cell Lymphoma

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.

Study Overview

• Status: Unknown
• Conditions: Febrile Neutropenia; Lymphoma, T-Cell, Peripheral

Detailed Description

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

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Dong-Yeop Shin, M.D.; Phone Number: +82-2-970-1246; Email: baramg@hanmail.net

Study Locations

• Korea, Republic of
  • Cheonan, Korea, Republic of
    • Not yet recruiting
    • Dankook University Hospital
  • Daegu, Korea, Republic of
    • Not yet recruiting
    • Keimyung University Dongsan Hospital
    • Contact: Young Rok Do
  • Daegu, Korea, Republic of
    • Not yet recruiting
    • Yeungnam University Hospital
  • Guri, Korea, Republic of
    • Not yet recruiting
    • Hanyang University Guri Hospital
  • Ilsan, Korea, Republic of
    • Not yet recruiting
    • Inje University Ilsan Paik Hospital
  • Ilsan, Korea, Republic of
    • Not yet recruiting
    • National Health and Insurance Service Ilsan Hospital
  • Pusan, Korea, Republic of
    • Not yet recruiting
    • Pusan National University Hospital
  • Pusan, Korea, Republic of
    • Not yet recruiting
    • Kosin Universithy Gospel Hospital
  • Seoul, Korea, Republic of
    • Recruiting
    • Asan Medical Center
    • Contact: Dok Hyun Yoon, M.D.,Ph.D.
  • Seoul, Korea, Republic of, 139-706
    • Recruiting
    • Korea Cancer Center Hospital
    • Contact: Dong-Yeop Shin, M.D.; Phone Number: +82-2970-1246; Email: baramg@hanmail.net
  • Seoul, Korea, Republic of
    • Recruiting
    • Samsung Medical Center
    • Contact: Won Seog Kim, M.D., Ph.D.
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Soonchunhyang University Hospital
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Choong Ang University Hospital
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Hallym University Hospital
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Hanyang University Hospital
  • Suwon, Korea, Republic of
    • Recruiting
    • Ajou University Hospital
    • Contact: Seong Hyun Jeong, M.D.,Ph.D.
  • Ulsan, Korea, Republic of
    • Not yet recruiting
    • Ulsan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Febrile neutropenia	Incidence and severity of febrile neutropenia	2 years after the last enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infectious complication	incidence, severity, microbiology of infection	2 years after the last enrollment

Collaborators and Investigators

• Sponsor: Korea Cancer Center Hospital
• Collaborators: Samsung Medical Center; Pusan National University Hospital; Asan Medical Center; Seoul National University Hospital; Ulsan University Hospital; Ajou University School of Medicine; Chung-Ang University Hosptial, Chung-Ang University College of Medicine; Inje University; Hanyang University; Yeungnam University Hospital; Keimyung University Dongsan Medical Center; Soonchunhyang University Hospital; Hanyang University Seoul Hospital; Hallym University Medical Center; Dankook University; Kosin University Gospel Hospital; National Health Insurance Service Ilsan Hospital
• Investigators: Principal Investigator: Won Seog Kim, M.D., Ph.D., Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: February 2, 2015
• First Submitted That Met QC Criteria: February 10, 2015
• First Posted (Estimate): February 18, 2015

Study Record Updates

• Last Update Posted (Estimate): February 18, 2015
• Last Update Submitted That Met QC Criteria: February 10, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Lymphoma; Neutropenia; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Febrile Neutropenia
• Other Study ID Numbers: Giraffe-T