Lenalidomide Plus Bendamustine and Rituximab for Untreated CLL/SLL
Lenalidomide in Combination With Bendamustine and Rituximab for Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma(CLL/SLL): a Phase I Study
Lenalidomide belongs to a group of drugs called immunomodulatory drugs (IMiD) that can modify or regulate the functioning of the immune system. It is an FDA approved drug for people with multiple myeloma. It is not currently approved for use in Chronic Lymphocytic Leukemia (CLL), but it does appear effective in CLL when used alone, and is being studied for use in combination with chemotherapy in this and other lymphomas and leukemias.
In this research study we are hoping to learn more about the effects of lenalidomide on CLL when given in combination with bendamustine and rituximab, which is a highly effective regimen for initial therapy of CLL/SLL. The investigators will be looking for the highest dose of lenalidomide that can be given safely, without causing any serious or unmanageable side effects.
研究概览
详细说明
Subjects will receive lenalidomide, bendamustine and rituximab in cycles of 28 days (4 weeks). Lenalidomide will be administered orally once daily on days 8-21 of cycle 1 and on days 1-21 of all subsequent cycles. Bendamustine will be administered through a vein (IV infusion) on days 1 and 2 of each cycle. Rituximab will be administered as an IV infusion on day 1 of each cycle.
Subjects will receive routine blood tests and physical exam during each cycle. Tumor assessments by CT scan will be performed during cycles 2, 4, and 6.
研究类型
注册 (预期的)
阶段
- 阶段1
联系人和位置
学习地点
-
-
Massachusetts
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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:
- Diagnosed with B-cell CLL or SLL (chronic lymphocytic leukemia or small lymphocytic leukemia)
- Life expectancy > 3 months
- Organ and marrow function with protocol parameters
- Able to take aspirin daily
Exclusion Criteria:
- Age >80 years
- Prior systemic therapy for CLL/SLL including chemotherapy or antibody therapy
- Pregnant or breast-feeding
- Serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing informed consent
- Known hypersensitivity to thalidomide or lenalidomide
- Prior use of lenalidomide
- Concurrent use of other anti-cancer agents or treatments
- HIV positive
- Prior history of another malignancy unless disease free for at least 2 years
- Uncontrolled intercurrent illness
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）
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Identify the maximum tolerated dose of lenalidomide when combined with bendamustine and rituximab in CLL/SLL
大体时间：2 years
|
2 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Define dose limiting toxicities of bendamustine, rituximab and lenalidomide in CLL
大体时间：2 year
|
2 year
|
|
|
Clinical efficacy
大体时间：2 years
|
response rate, progression-free and overall survival
|
2 years
|
合作者和调查者
调查人员
- 首席研究员：Jeremy Abramson, M.D.、Massachusetts General Hospital
研究记录日期
研究主要日期
学习开始
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
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.