Panobinostat With Rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma
Panobinostat in Combination With Rituximab For Relapsed/Refractory Diffuse Large B Cell Lymphoma
研究概览
详细说明
Study treatment will be given in 4 week periods called cycles. Panobinostat will be taken orally on Monday, Wednesday, and Friday of each week. Rituximab will be given as an intravenous infusion weekly during Cycle 1 and then once per month on day 1 of subsequent cycles. Subjects can receive up to 6 cycles of treatment. Blood draws and 2 EKGs (electrocardiograms) will be done weekly in Cycle 1 and then once in each cycle. PET/CT (Positron Emission Tomography/Computed Tomography) scans will be done every 2 months.
If disease has not progressed after 6 cycles on combination of panobinostat and rituximab, subjects may continue on panobinostat alone for up to 6 additional months.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02215
- Beth Israel Deaconess Medical Center
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Boston、Massachusetts、美国、02215
- Dana-Farber Cancer Institute
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Boston、Massachusetts、美国、02214
- Massachusetts General Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Relapsed or refractory DLBCL
- More than 1 line of prior chemotherapy
Exclusion Criteria:
- Currently receiving anticancer therapy or investigational agents
- Major surgery within last 4 weeks
- Known leptomeningeal or brain metastases
- Known HIV infection
- Uncontrolled fungal, bacterial, viral or other infection
- History of another malignancy (except for non-melanoma skin cancer or in situ cervical or breast cancer) unless disease free for at least 3 years
- Hepatitis B or C positive
- GI disease
- Pregnant or breastfeeding
- Prior treatment with an HDAC inhibitor including valproic acid
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Panobinostat/Rituximab
single-arm, open-label; Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.
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Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.
其他名称：
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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 |
|---|---|---|
|
Overall Response Rate
大体时间：1 year
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Overall response rate is defined by the Revised International Workshop Response Criteria (2007) (see reference in protocol section). Overall response (OR) = Complete response (CR) + Partial response (PR) |
1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Progression-free Survival Rate
大体时间：6 months
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Progression is defined by the Revised International Workshop Response Criteria (2007) (see reference in protocol section).
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6 months
|
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Toxicities
大体时间：1 year
|
Evaluate safety of this combination in relapsed/refractory DLBCL patients Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening
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1 year
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合作者和调查者
调查人员
- 首席研究员：Jeremy S Abramson, MD、Massachusetts General Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 10-441
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