Histologically Proven Extranodal NKTcell LymphomaEarly Phase 1Ro-ENKTLNCT01913119
A Pilot Study of Romidepsin in Relapsed or Refractory Extranodal NK/T-cell Lymphoma
A Early Phase 1 study testing Romidepsin in people with Histologically Proven Extranodal NKTcell Lymphoma, run by Samsung Medical Center at 4 sites in South Korea.
Trial summary
Extranodal NK/T-cell lymphoma is a rare disease entity with aggressive clinical course and poor prognosis. Currently, there is no treatment option for relapsed or refractory extranodal NK/T-cell lymphoma. Romidepsin is a histone deacetylase inhibitor which was approved for cutaneous T-cell lymphoma. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Histologically Proven Extranodal NKTcell Lymphoma
- What is being tested?
- Romidepsin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Jul 2013to Jul 2013
- Phase
- Early Phase 1
- 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient should belong to any one of following clinical situations
- Relapsed after salvage chemotherapy
- Relapsed after autologous stem cell transplantation
- Refractory to salvage chemotherapy or autologous stem cell transplantation
- Adequate organ function as defined by the following criteria:
- Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase (SGOT)) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase (SGPT)) ≤2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy
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- Total serum bilirubin ≤ 1.5 x ULN
- Absolute neutrophil count (ANC) ≥1500/µL
- Platelets ≥ 75,000/µL
- Hemoglobin ≥ 9.0 g/dL (may be transfused or erythropoietin treated)
- Serum calcium ≤ 12.0 mg/dL
- Serum creatinine ≤ 1.5 x ULN
- At least one measurable lesion
- ECOG PS 0-2
- Written informed consent
- Over 20 years and under 80 years of age
Who cannot join
- Previously received allogeneic stem cell transplantation
- History of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease or secondary CNS involvement on CT or MRI scan.
- Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2.
- Pregnancy or breastfeeding.
- Any Known cardiac abnormalities
- HBV carrier
- Positive for HIV
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
National Cancer Center
Goyang-si, Gyeonggi-do, 410-769
Korea Cancer Center Hospital
Nowon-gu, Seoul, 139-709
Severance Hospital
Seodaemun-gu, Seoul, 120-752
Asan Medical Center
Songpa-gu, Seoul, 138-736
About this study
Official title: A Pilot Study of Romidepsin in Relapsed or Refractory Extranodal NK/T-cell
Extranodal NK/T-cell lymphoma is a rare disease entity with aggressive clinical course and poor prognosis. Currently, there is no treatment option for relapsed or refractory extranodal NK/T-cell lymphoma. Romidepsin is a histone deacetylase inhibitor which was approved for cutaneous T-cell lymphoma. A recent phase II study of romidepsin for relapsed/refractory peripheral T-cell lymphoma reported an overall response rate of 38% (95% confidence interval 24%-53%). The median duration of overall response was 8.9 months. Considering the median number of previous treatments in these patients was three (range 1-11), romidepsin has single agent activity against relapsed/refractory T-cell lymphoma. Thus, if the single agent activity of romidepsin is demonstrated, it could be a therapeutic agent for combination with salvage treatment.
- Being tested
- Romidepsin
- Keywords
- extranodal NKTcell lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RomidepsinDrug
Also called Istodax
Day 1, 8, and 15 of a 28-day cycle Romidepsin Treatment is repeated until documented disease progression or unacceptable toxicity.
Dose and administration: 4-hour infusion of 14 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Romidepsin | Experimental | Day 1, 8, and 15 of a 28-day cycle Romidepsin Treatment is repeated until documented disease progression or unacceptable toxicity.
Dose and administration: 4-hour infusion of 14 mg/m2 Receives: Drug: Romidepsin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of overall disease control including CR, PR, and SD
Overall rate of disease control including CR, PR and SD Overall survival: Time between the date of treatment start and the date of death due to any cause
Measured: Time between the date of treatment start and the date of death
Secondary outcomes (3)
Number of participants with adverse events
Number of participants with adverse events
Measured: from the date of informed consent signature to 30 days after last drug administration
Time to progression
Performing Cervical, Chest, Abdomen and Pelvis CT scan for the assessment
Measured: from the date of first drug administration until the date of first documented progression
overall survival
Overall Survival will be measured from the date of first drug administration to the date of death from any cause.
Measured: from the date of first drug administration until the date of death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Histologically Proven Extranodal NKTcell 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Principal investigator, Won Seog Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913119
- Sponsor's protocol ID
- 2012-10-059
- Acronym
- Ro-ENKTL
- Status last verified
- Jul 2013
- First submitted
- 19 Jul 2013
- Last updated
- 31 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Romidepsin in Relapsed or Refractory Extranodal NK/T-cell
- ClinicalTrials.gov ID
- NCT01913119
- Acronym / sponsor ID
- Ro-ENKTL / 2012-10-059
- Keywords
- extranodal NKTcell lymphoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Jul 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 31 Jul 2013 (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.
Extranodal NK/T-cell lymphoma is a rare disease entity with aggressive clinical course and poor prognosis. Currently, there is no treatment option for relapsed or refractory extranodal NK/T-cell lymphoma. Romidepsin is a histone deacetylase inhibitor which was approved for cutaneous T-cell lymphoma. A recent phase II study of romidepsin for relapsed/refractory peripheral T-cell lymphoma reported an overall response rate of 38% (95% confidence interval 24%-53%). The median duration of overall response was 8.9 months. Considering the median number of previous treatments in these patients was three (range 1-11), romidepsin has single agent activity against relapsed/refractory T-cell lymphoma. Thus, if the single agent activity of romidepsin is demonstrated, it could be a therapeutic agent for combination with salvage treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Romidepsin | Experimental | Drug: RomidepsinDay 1, 8, and 15 of a 28-day cycle Romidepsin Treatment is repeated until documented disease progression or unacceptable toxicity. Dose and administration: 4-hour infusion of 14 mg/m2 |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patient should belong to any one of following clinical situations
- Adequate organ function as defined by the following criteria:
- At least one measurable lesion
- ECOG PS 0-2
- Written informed consent
Key exclusion criteria (7 listed)
- Previously received allogeneic stem cell transplantation
- History of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease or secondary CNS involvement on CT or MRI scan.
- Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2.
- Pregnancy or breastfeeding.
- Any Known cardiac abnormalities
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 |
|---|---|---|
| RomidepsinAlso: IstodaxDay 1, 8, and 15 of a 28-day cycle Romidepsin Treatment is repeated until documented disease progression or unacceptable toxicity. Dose and administration: 4-hour infusion of 14 mg/m2 | Drug | Romidepsin |
Primary outcome
Rate of overall disease control including CR, PR, and SD
Time frame: Time between the date of treatment start and the date of death
Overall rate of disease control including CR, PR and SD Overall survival: Time between the date of treatment start and the date of death due to any cause
3 secondary outcomes
Number of participants with adverse events
Time frame: from the date of informed consent signature to 30 days after last drug administration
Time to progression
Time frame: from the date of first drug administration until the date of first documented progression
overall survival
Time frame: from the date of first drug administration until the date of death
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 31 Jul 2013.
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Romidepsin in people with Histologically Proven Extranodal NKTcell Lymphoma, run by Samsung Medical Center at 4 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 16 inclusion and 7 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 31 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Rate of overall disease control including CR, PR, and SD (time frame: Time between the date of treatment start and the date of death). 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 31 Jul 2013; AzTrials last refreshed its copy on 6 Nov 2026.