NK/T Cell LymphomaNCT01660568
Gemcitabine in NK/T Cell Lymphoma
An observational study of NK/T Cell Lymphoma, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
We retrospectively review patients with refractory or relapsed ENKL who received a gemcitabine-containing regimen Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- NK/T Cell Lymphoma
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2012to Jan 2013
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: relapsed or refractory NK/T cell lymphoma treated with gemcitabine conatining treatment
Who may be able to join
- NK/T cell lymphoma
- relapse or refractory disease
- gemcitabine containing treatment
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gemcitabine in Pretreated/Refractory NK/T Cell Lymphoma
We retrospectively review patients with refractory or relapsed ENKL who received a gemcitabine-containing regimen
- Conditions
- NK/T Cell Lymphoma
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| relapsed or refractory NK/T cell lymphoma with gemcitabine | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: 2012-May
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NK/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
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01660568
- Sponsor's protocol ID
- 2012-07-043
- Status last verified
- Aug 2012
- First submitted
- 6 Aug 2012
- Last updated
- 13 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gemcitabine in Pretreated/Refractory NK/T Cell Lymphoma
- ClinicalTrials.gov ID
- NCT01660568
- Acronym / sponsor ID
- 2012-07-043
- Conditions
- NK/T Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 8 Aug 2012 (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.
We retrospectively review patients with refractory or relapsed ENKL who received a gemcitabine-containing regimen
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| relapsed or refractory NK/T cell lymphoma with gemcitabine | – | – |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- relapsed or refractory NK/T cell lymphoma treated with gemcitabine conatining treatment
Key inclusion criteria (3 listed)
- NK/T cell lymphoma
- relapse or refractory disease
- gemcitabine containing treatment
Key exclusion criteria (0 listed)
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
Overall response rate
Time frame: 2012-May
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 13 Feb 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 NK/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 3 inclusion and 0 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 13 Feb 2013. 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 response rate (time frame: 2012-May). 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 13 Feb 2013.