Lymphoma, T-Cell, PeripheralNCT02364466
Cohort of Peripheral T Cell Lymphoma
An observational study of Lymphoma, T-Cell, Peripheral and Febrile Neutropenia, run by Korea Cancer Center Hospital at 18 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lymphoma, T-Cell, Peripheral, Febrile Neutropenia
- How many people
- 200 participants
- Where
- 18 sitesSouth Korea
- Study dates
- Jan 2015to Dec 2019
- How long will I take part?
- 2019 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
South Korea18 sites, 18 recruiting
- Not yet recruiting
Dankook University Hospital
Cheonan
- Not yet recruiting
Keimyung University Dongsan Hospital
Daegu
Young Rok Do
- Not yet recruiting
Yeungnam University Hospital
Daegu
- Not yet recruiting
Hanyang University Guri Hospital
Guri-si
- Not yet recruiting
Inje University Ilsan Paik Hospital
Ilsan
- Not yet recruiting
National Health and Insurance Service Ilsan Hospital
Ilsan
- Not yet recruiting
Kosin Universithy Gospel Hospital
Pusan
- Not yet recruiting
Pusan National University Hospital
Pusan
- Recruiting
Korea Cancer Center Hospital
Seoul, 139-706
Dong-Yeop Shin, M.D., +82-2970-1246, baramg@hanmail.net
- Recruiting
Asan Medical Center
Seoul
Dok Hyun Yoon, M.D.,Ph.D.
- Not yet recruiting
Choong Ang University Hospital
Seoul
- Not yet recruiting
Hallym University Hospital
Seoul
- Not yet recruiting
Hanyang University Hospital
Seoul
- Recruiting
Samsung Medical Center
Seoul
Won Seog Kim, M.D., Ph.D.
- Not yet recruiting
Seoul National University Hospital
Seoul
- Not yet recruiting
Soonchunhyang University Hospital
Seoul
- Recruiting
Ajou University Hospital
Suwon
Seong Hyun Jeong, M.D.,Ph.D.
- Not yet recruiting
Ulsan University Hospital
Ulsan
About this study
Official title: 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.
Read the detailed description
Prospective evaluation of frequencies of febrile neutropenia or infectious complications in a homogeneous population of patients with peripheral T cell lymphoma
- Conditions
- Lymphoma, T-Cell, Peripheral, Febrile Neutropenia
- Medical subject headings
- Lymphoma, T-Cell, Peripheral, Febrile Neutropenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Febrile neutropenia
Incidence and severity of febrile neutropenia
Measured: 2 years after the last enrollment
Secondary outcomes (1)
Infectious complication
incidence, severity, microbiology of infection
Measured: 2 years after the last enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, T-Cell, PeripheralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2019 Years
Sponsor and investigators
- Lead sponsor
- Korea Cancer Center Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Medical Center, Asan Medical Center, Keimyung University Dongsan Medical Center, Kosin University Gospel Hospital, Dankook University, Soonchunhyang University Hospital, Ajou University School of Medicine, Yeungnam University Hospital, Ulsan University Hospital, Inje University, Chung-Ang University Hospital, Hallym University Medical Center, Hanyang University Seoul Hospital, Seoul National University Hospital, Pusan National University Hospital, National Health Insurance Service Ilsan Hospital, Hanyang University
- Responsible party
- Principal investigator, Sujin Kang, Korea Cancer Center Hospital
- Investigators
- Won Seog Kim, M.D., Ph.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364466
- Sponsor's protocol ID
- Giraffe-T
- Status last verified
- Feb 2015
- First submitted
- 2 Feb 2015
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Cohort Study of Peripheral T Cell Lymphoma
- ClinicalTrials.gov ID
- NCT02364466
- Acronym / sponsor ID
- Giraffe-T
- Conditions
- Lymphoma, T-Cell, Peripheral, Febrile Neutropenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Korea Cancer Center HospitalUniversity, hospital or other
- Collaborators
- Samsung Medical Center, Asan Medical Center, Keimyung University Dongsan Medical Center, Kosin University Gospel Hospital, Dankook University, Soonchunhyang University Hospital, Ajou University School of Medicine, Yeungnam University Hospital, Ulsan University Hospital, Inje University, Chung-Ang University Hospital, Hallym University Medical Center, Hanyang University Seoul Hospital, Seoul National University Hospital, Pusan National University Hospital, National Health Insurance Service Ilsan Hospital, Hanyang University
- Study start
- Jan 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 18 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2019 Years
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- Treatment naive peripheral T cell lymphoma
- 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
Key exclusion criteria (6 listed)
- Other histology than those described above
- Other combined malignancy
- Previous history of chemotherapy or radiation therapy
- No informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Febrile neutropenia
Time frame: 2 years after the last enrollment
Incidence and severity of febrile neutropenia
1 secondary outcome
Infectious complication
Time frame: 2 years after the last enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Won Seog Kim, M.D., Ph.D. principal investigator
Samsung Medical Center
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, T-Cell, Peripheral and Febrile Neutropenia, run by Korea Cancer Center Hospital at 18 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong-Yeop Shin, M.D. (+82-2-970-1246, baramg@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Febrile neutropenia (time frame: 2 years after the last enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2015.