NCT02364466

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

18 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 18, 2015

Status Verified

February 1, 2015

Enrollment Period

4.9 years

First QC Date

February 2, 2015

Last Update Submit

February 10, 2015

Conditions

Lymphoma, T-Cell, PeripheralFebrile Neutropenia

Outcome Measures

Primary Outcomes (1)

  • Febrile neutropenia

    Incidence and severity of febrile neutropenia

    2 years after the last enrollment

Secondary Outcomes (1)

  • Infectious complication

    2 years after the last enrollment

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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
  • years old or over
  • Expected survival is more than 6 months
  • Informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Dankook University Hospital

Cheonan, South Korea

NOT YET RECRUITING

Keimyung University Dongsan Hospital

Daegu, South Korea

NOT YET RECRUITING

Yeungnam University Hospital

Daegu, South Korea

NOT YET RECRUITING

Hanyang University Guri Hospital

Guri-si, South Korea

NOT YET RECRUITING

Inje University Ilsan Paik Hospital

Ilsan, South Korea

NOT YET RECRUITING

National Health and Insurance Service Ilsan Hospital

Ilsan, South Korea

NOT YET RECRUITING

Kosin Universithy Gospel Hospital

Pusan, South Korea

NOT YET RECRUITING

Pusan National University Hospital

Pusan, South Korea

NOT YET RECRUITING

Korea Cancer Center Hospital

Seoul, 139-706, South Korea

RECRUITING

Asan Medical Center

Seoul, South Korea

RECRUITING

Choong Ang University Hospital

Seoul, South Korea

NOT YET RECRUITING

Hallym University Hospital

Seoul, South Korea

NOT YET RECRUITING

Hanyang University Hospital

Seoul, South Korea

NOT YET RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

NOT YET RECRUITING

Soonchunhyang University Hospital

Seoul, South Korea

NOT YET RECRUITING

Ajou University Hospital

Suwon, South Korea

RECRUITING

Ulsan University Hospital

Ulsan, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, PeripheralFebrile Neutropenia

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeutropeniaAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesLeukocyte Disorders

Study Officials

  • Won Seog Kim, M.D., Ph.D.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong-Yeop Shin, M.D.

CONTACT

+82-2-970-1246baramg@hanmail.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2019 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CRA

Study Record Dates

First Submitted

February 2, 2015

First Posted

February 18, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

February 18, 2015

Record last verified: 2015-02

Locations

KR(18)