Lenalidomide and Decitabine in High Grade Myelodysplastic Syndromes
A Phase I Study of Lenalidomide in Combination With Decitabine for Patients With High Grade Myelodysplastic Syndromes
研究概览
详细说明
Myelodysplastic syndrome (MDS) is a group of different kinds of stem cell abnormalities. It is characterized by low blood counts and abnormal blood cell formation. These abnormal blood cells can cause fatigue, shortness of breath, infection, and bleeding. There is significant risk of developing acute leukemia in this disorder.
The only known curative therapy is an allogeneic bone marrow transplant of which the vast majority of patients with this disorder are not candidates. Currently three drugs have been approved for the treatment of MDS: azacytidine, decitabine and lenalidomide for low grade patients with a chromosome 5q abnormality. Azacytidine and decitabine have been demonstrated to improve blood counts, improve the quality of life, and decrease the risk of progression to AML or death in a sizable minority of MDS patients. A recent study of MDS patients who had responded clinically to decitabine revealed that their bone marrow biopsies still showed stromal abnormalities such as increased angiogenesis. Lenalidomide acts at the level of the stromal - marrow cell interaction. It is hypothesized that the combination of decitabine with lenalidomide may show synergistic results.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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North Carolina
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Durham、North Carolina、美国、27710
- Duke University Medical Center
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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:
- Understand and voluntarily sign an informed consent form.
- Age >/=18 years at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- Myelodysplastic syndrome (documented by bone marrow biopsy) with IPSS score of Int-2 or High risk.
- All previous MDS therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 28 days prior to treatment in this study.
- ECOG performance status of </= 2 at study entry.
- Laboratory test results within these ranges: Serum creatinine </= 2.5 mg/dL x ULN, Total bilirubin </= 2.5 mg/dL x ULN, AST (SGOT) and ALT (SGPT) </= 3 x ULN.
- All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
- Females of childbearing potential must have a negative serum pregnancy test within 10-14 days prior to and again within 24 hours of prescribing lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. Must also agree to ongoing pregnancy testing.
- Men must agree to use a latex condom during sexual contact even if they have had a successful vasectomy.
- Disease free of prior malignancies for >/= 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, localized prostate cancer, or carcinoma "insitu" of the cervix or breast.
Exclusion Criteria:
- Any serious medical condition, laboratory abnormality, or psychiatric
- Pregnant or breast feeding females.
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Known hypersensitivity or reaction to thalidomide, lenalidomide or decitabine.
- Any prior use of lenalidomide.
- Concurrent use of other anti-cancer agents or anti-cancer treatments.
- Known positive for HIV or active infectious hepatitis, type A, B or C.
- History of thromboembolic event within past 6 months prior to enrollment.
学习计划
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）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Cohort 1
Lenalidomide (5mg) and Decitabine
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Decitabine 20mg/m2 over one hour IV for 5 days, with cycles repeated every 28 days.
Lenalidomide given orally on Days 1-21 followed by 7 days of rest at various dose escalated cohorts (5 mg, 10mg, 15mg, 20 mg, 25 mg)
其他名称：
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实验性的：Cohort 2
Lenalidomide (10 mg) and Decitabine
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Decitabine 20mg/m2 over one hour IV for 5 days, with cycles repeated every 28 days.
Lenalidomide given orally on Days 1-21 followed by 7 days of rest at various dose escalated cohorts (5 mg, 10mg, 15mg, 20 mg, 25 mg)
其他名称：
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实验性的：Cohort 3
Lenalidomide (15 mg) and Decitabine
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Decitabine 20mg/m2 over one hour IV for 5 days, with cycles repeated every 28 days.
Lenalidomide given orally on Days 1-21 followed by 7 days of rest at various dose escalated cohorts (5 mg, 10mg, 15mg, 20 mg, 25 mg)
其他名称：
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实验性的：Cohort 4
Lenalidomide (20 mg) and Decitabine
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Decitabine 20mg/m2 over one hour IV for 5 days, with cycles repeated every 28 days.
Lenalidomide given orally on Days 1-21 followed by 7 days of rest at various dose escalated cohorts (5 mg, 10mg, 15mg, 20 mg, 25 mg)
其他名称：
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实验性的：Cohort 5
Lenalidomide (25 mg) and Decitabine
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Decitabine 20mg/m2 over one hour IV for 5 days, with cycles repeated every 28 days.
Lenalidomide given orally on Days 1-21 followed by 7 days of rest at various dose escalated cohorts (5 mg, 10mg, 15mg, 20 mg, 25 mg)
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 |
大体时间 |
|---|---|
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Maximally tolerated dose (MTD)as defined by the protocol
大体时间：Cycle 1
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Cycle 1
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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反应持续时间
大体时间：2年
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2年
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effect on cytogenetic abnormalities
大体时间：6 months
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6 months
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合作者和调查者
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 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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