Non-Hodgkin T-cell LymphomaNCT02691351
Intercontinental Cooperative Non-Hodgkin T-cell Lymphoma Prospective Registry Study
An observational study of Non-Hodgkin T-cell Lymphoma, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The better understanding of non-Hodgkin T-cell lymphoma is essential for establishing effective treatment strategy for non-Hodgkin T-cell lymphoma. Therefore, the data about conical features and treatment outcomes of each subtype should be accumulated to establish treatment strategy. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Non-Hodgkin T-cell Lymphoma
- What is being tested?
- Prospective Registry
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2016to Sep 2020
- How long will I take part?
- 5 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: T-cell non-Hodgkin lymphoma
Who may be able to join
- Pathologically diagnosed Mature T-cell non-Hodgkin lymphoma based on the World Health Organization classification 2008
- Newly diagnosed patients without a previous treatment history for T-cell lymphoma or relapsed/refractory T-cell lymphoma patients
- Age ≥19 years
- Written informed consent
Who cannot join
- Hodgkin lymphoma
- non-Hodgkin B-cell lymphoma
- Immature non-Hodgkin T-cell lymphoma: Precursor T-lymphoblastic lymphoma/leukemia
- Not understanding informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The better understanding of non-Hodgkin T-cell lymphoma is essential for establishing effective treatment strategy for non-Hodgkin T-cell lymphoma. Therefore, the data about conical features and treatment outcomes of each subtype should be accumulated to establish treatment strategy. However, the majority of previous data for non-Hodgkin T-cell lymphoma was from small case series of single institute. Furthermore, as novel drugs were developed for the treatment of relapsed or refractory T-cell lymphoma, the date from patients who were treated with those novel drugs are especially required because their outcomes may reflect the outcomes of currently available treatments. Thus, a multinational, multicenter prospective registry study is needed to provide information useful for establishing treatment strategies for T-cell lymphoma.
- Conditions
- Non-Hodgkin T-cell Lymphoma
- Being tested
- Prospective Registry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective RegistryOther
Survival and disease status follow-up at 1st primary treatment, 1st salvage treatment and 2nd salvage treatment
- Regimen
- Response Evaluation
- SUSAR(Suspected, Unexpected, Serious, Adverse Reaction) collection
| Study group | Role | What they receive |
|---|---|---|
| non-Hodgkin T-cell Lymphoma | Not described Receives: Other: Prospective Registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 5 years
Secondary outcomes (2)
Overall response rate to primary treatment and salvage treatment
Measured: 5 years
Progression-free survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- 500 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Seog Kim, Samsung Medical Center
- Investigators
- Won seog Kim, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691351
- Sponsor's protocol ID
- 2015-11-070
- Status last verified
- Sep 2020
- First submitted
- 17 Feb 2016
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intercontinental Cooperative Non-Hodgkin T-cell Lymphoma Prospective Registry Study
- ClinicalTrials.gov ID
- NCT02691351
- Acronym / sponsor ID
- 2015-11-070
- Conditions
- Non-Hodgkin T-cell Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 25 Feb 2016 (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.
The better understanding of non-Hodgkin T-cell lymphoma is essential for establishing effective treatment strategy for non-Hodgkin T-cell lymphoma. Therefore, the data about conical features and treatment outcomes of each subtype should be accumulated to establish treatment strategy. However, the majority of previous data for non-Hodgkin T-cell lymphoma was from small case series of single institute. Furthermore, as novel drugs were developed for the treatment of relapsed or refractory T-cell lymphoma, the date from patients who were treated with those novel drugs are especially required because their outcomes may reflect the outcomes of currently available treatments. Thus, a multinational, multicenter prospective registry study is needed to provide information useful for establishing treatment strategies for T-cell lymphoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-Hodgkin T-cell Lymphoma | – | Other: Prospective Registry |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- T-cell non-Hodgkin lymphoma
Key inclusion criteria (4 listed)
- Pathologically diagnosed Mature T-cell non-Hodgkin lymphoma based on the World Health Organization classification 2008
- Newly diagnosed patients without a previous treatment history for T-cell lymphoma or relapsed/refractory T-cell lymphoma patients
- Age ≥19 years
- Written informed consent
Key exclusion criteria (4 listed)
- Hodgkin lymphoma
- non-Hodgkin B-cell lymphoma
- Immature non-Hodgkin T-cell lymphoma: Precursor T-lymphoblastic lymphoma/leukemia
- Not understanding 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective RegistrySurvival and disease status follow-up at 1st primary treatment, 1st salvage treatment and 2nd salvage treatment 1. Regimen 2. Response Evaluation 3. SUSAR(Suspected, Unexpected, Serious, Adverse Reaction) collection | Other | non-Hodgkin T-cell Lymphoma |
Primary outcome
Overall survival
Time frame: 5 years
2 secondary outcomes
Overall response rate to primary treatment and salvage treatment
Time frame: 5 years
Progression-free survival
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
Related trials for Non-Hodgkin T-cell Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
Active, not recruitingPhase 2
Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
Mycosis Fungoides, Lymphomatoid Papulosis
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
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, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Hodgkin T-cell Lymphoma, run by Samsung Medical Center at 1 site 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 years). 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 9 Sep 2020.