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| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Romidepsin | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Time between the date of treatment start and the date of death |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Number of participants with adverse events | from the date of informed consent signature to 30 days after last drug administration |
| Time to progression |
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Inclusion Criteria:
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
Over 20 years and under 80 years of age
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Goyang-si | Gyeonggi-do | 410-769 | South Korea | ||
| Korea Cancer Center Hospital |
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| ID | Term |
|---|---|
| C087123 | romidepsin |
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|
Performing Cervical, Chest, Abdomen and Pelvis CT scan for the assessment
| 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. | from the date of first drug administration until the date of death |
| Nowon-gu |
| Seoul |
| 139-709 |
| South Korea |
| Severance Hospital | Seodaemun-gu | Seoul | 120-752 | South Korea |
| Asan Medical Center | Songpa-gu | Seoul | 138-736 | South Korea |