Histologically Proven Extranodal NKTcell Lymphoma Clinical Trial
— Ro-ENKTLOfficial title:
A Pilot Study of Romidepsin in Relapsed or Refractory Extranodal NK/T-cell
| Verified date | July 2013 |
| Source | Samsung Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | South Korea: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 16 |
| Est. completion date | July 2013 |
| Est. primary completion date | July 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 79 Years |
| Eligibility |
Inclusion Criteria: 1. Patient should belong to any one of following clinical situations 1. Relapsed after salvage chemotherapy 2. Relapsed after autologous stem cell transplantation 3. Refractory to salvage chemotherapy or autologous stem cell transplantation 2. Adequate organ function as defined by the following criteria: 1. 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 2. Total serum bilirubin = 1.5 x ULN 3. Absolute neutrophil count (ANC) =1500/µL 4. Platelets = 75,000/µL 5. Hemoglobin = 9.0 g/dL (may be transfused or erythropoietin treated) 6. Serum calcium = 12.0 mg/dL 7. Serum creatinine = 1.5 x ULN 3. At least one measurable lesion 4. ECOG PS 0-2 5. Written informed consent 6. Over 20 years and under 80 years of age Exclusion Criteria: 1. Previously received allogeneic stem cell transplantation 2. History of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease or secondary CNS involvement on CT or MRI scan. 3. Ongoing cardiac dysrhythmias of NCI CTCAE grade =2. 4. Pregnancy or breastfeeding. 5. Any Known cardiac abnormalities 6. HBV carrier 7. Positive for HIV |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | National Cancer Center | Goyang-si | Gyeonggi-do |
| Korea, Republic of | Korea Cancer Center Hospital | Nowon-gu | Seoul |
| Korea, Republic of | Severance Hospital | Seodaemun-gu | Seoul |
| Korea, Republic of | Asan Medical Center | Songpa-gu | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Samsung Medical Center | Celgene Corporation |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Secondary | 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 | Yes |
| Secondary | Time to progression | 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 | Yes |
| Secondary | 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 | Yes |