A Pilot Study of Romidepsin in Relapsed or Refractory Extranodal NK/T-cell
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Rate of overall disease control including CR, PR, and SD
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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 ≥
- •Pregnancy or breastfeeding.
- •Any Known cardiac abnormalities
- •HBV carrier
- •Positive for HIV
研究组 & 干预措施
Romidepsin
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
干预措施: Romidepsin (Drug)
结局指标
主要结局
Rate of overall disease control including CR, PR, and SD
时间窗: 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
次要结局
- Number of participants with adverse events(from the date of informed consent signature to 30 days after last drug administration)
- Time to progression(from the date of first drug administration until the date of first documented progression)
- overall survival(from the date of first drug administration until the date of death)
研究者
Won Seog Kim
professor
Samsung Medical Center