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A Pilot Study of Romidepsin in Relapsed or Refractory Extranodal NK/T-cell Lymphoma (Ro-ENKTL)

2013年7月29日更新者：Won Seog Kim、Samsung Medical Center

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.

研究概览

地位

完全的

条件

Histologically Proven Extranodal NKTcell Lymphoma

干预/治疗

药品：Romidepsin

研究类型

介入性

注册 (实际的)

阶段

第一阶段早期

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

大韩民国
- Gyeonggi-do
  - Goyang-si、Gyeonggi-do、大韩民国、410-769
    - National Cancer Center
- Seoul
  - Nowon-gu、Seoul、大韩民国、139-709
    - Korea Cancer Center Hospital
  - Seodaemun-gu、Seoul、大韩民国、120-752
    - Severance Hospital
  - Songpa-gu、Seoul、大韩民国、138-736
    - Asan Medical Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年至 79年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

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
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
At least one measurable lesion
ECOG PS 0-2
Written informed consent
Over 20 years and under 80 years of age

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：非随机化
介入模型：单组作业
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：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	药品：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 其他名称：螺柱

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Rate of overall disease control including CR, PR, and SD 大体时间：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	Time between the date of treatment start and the date of death

次要结果测量

结果测量	措施说明	大体时间
Number of participants with adverse events 大体时间：from the date of informed consent signature to 30 days after last drug administration	Number of participants with adverse events	from the date of informed consent signature to 30 days after last drug administration
Time to progression 大体时间：from the date of first drug administration until the date of first documented 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
overall survival 大体时间：from the date of first drug administration until the date of death	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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Samsung Medical Center

合作者

Celgene Corporation

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年7月1日

初级完成 (实际的)

2013年7月1日

研究完成 (实际的)

2013年7月1日

研究注册日期

首次提交

2013年7月19日

首先提交符合 QC 标准的

2013年7月29日

首次发布 (估计)

2013年7月31日

研究记录更新

最后更新发布 (估计)

2013年7月31日

上次提交的符合 QC 标准的更新

2013年7月29日

最后验证

2013年7月1日

A Pilot Study of Romidepsin in Relapsed or Refractory Extranodal NK/T-cell Lymphoma (Ro-ENKTL)