NCT00097929已完成2 期
A Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Objective response rate based on FDG-PET and CT scan findings.
研究概览
简要总结
A study to determine the safety, tolerability, and anti-tumor effectiveness of an oral investigational drug in the treatment of relapsed diffuse large B-cell lymphoma.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be 18 years or older with relapsed Diffuse Large B-cell Lymphoma (DLBCL).
- •Stable disease or better for at least 3 months on most recent treatment
- •Have not received any chemotherapy, radiation therapy, major surgery, or any other investigational therapy for at least 4 weeks prior to entry in this study
- •Adequate blood testing, liver, and kidney function as required by the study.
- •Eligible subjects will allow tissue samples to be examined and stored.
排除标准
- •Patient has been treated with other investigational agents with a similar anti-tumor mechanism.
- •Patient should not have failed more than 3 prior treatment regimens.
结局指标
主要结局
Objective response rate based on FDG-PET and CT scan findings.
次要结局
- Response duration, Progression-free survival, Time to progression, Time to response, 3-Month and 6-month progression free survival.
研究者
相似试验
进行中（未招募）
1 期
A Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (L-001079038) in Patients with Relapsed Diffuse Large B-Cell Lymphoma (DLBCL) - L-001079038 in Relapsed DLBCEUCTR2004-001907-36-GBMerck Sharp & Dohme Limited50
终止
1 期
An Investigational Study of a Histone Deacetylase (HDAC) Inhibitor Plus Targretin in Cutaneous T-Cell Lymphoma Patients (0683-016)(TERMINATED)LymphomaNCT00127101Merck Sharp & Dohme LLC23
已完成
1 期
Suberoylanilide Hydroxamic Acid in Advanced Solid TumorsAdvanced CancerNCT00106626Merck Sharp & Dohme LLC52
终止
2 期
A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Relapsed or Refractory Breast, Colorectal and Non-Small Cell Lung Cancer (0683-011)(TERMINATED)Non-small-cell Lung CarcinomaBreast CancerColorectal CancerNCT00126451Merck Sharp & Dohme LLC16
终止
1 期
Study of Oral Vorinostat in Combination With Topotecan in Patients With Chemosensitive Recurrent SCLCSmall Cell Lung CancerNCT00697476Armando Santoro, MD2