A Phase I Study of Lenalidomide in Combination With Rituximab and Ibrutinib in Relapsed and Refractory CLL and SLL
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Recommended Phase II dose
研究概览
简要总结
This study is for subjects diagnosed with recurrent or relapsed CLL/SLL. The purpose of this study is to test the safety of the combination of the drugs lenalidomide and ibrutinib at different dose levels, in combination with the drug rituximab. We want to find out what effects, good and/or bad, they have on patients with CLL/SLL.
The hypothesis of the study is that it will be safe to give the three drugs in combination and the information learned from this trial will be used to study the 3 drug combination is a larger future trial.
详细描述
Treatment consists of dose escalations of lenalidomide and ibrutinib and fixed doses of rituximab. A small expansion cohort to include 10 patients will follow once the recommended phase II dose is found.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma that requires treatment
- •No prior systemic treatment within 4 weeks of enrollment
- •No corticosteroids within 2 weeks prior to study entry
- •Measurable disease must be present
- •No concomitant anti-cancer therapies
- •ECOG status </= 2
- •Patients with HIV infection are eligible
- •Patients with treated CLL or SLL in CNS are eligible
- •Non-pregnant and non-nursing
- •Life expectancy greater than 60 days
- •Adequate bone marrow, kidney and liver function
- •No major surgery within 28 days or minor surgery within 5 days of starting treatment
排除标准
- •History od Richter's transformation
- •History of prior allogeneic transplant
- •Radioimmunotherapy within 1 year of enrollment
- •Prior Bruton's tyrosine kinase inhibitor or lenalidomide
- •History of allergic reactions to compounds similar to ibrutinib, lenalidomide or rituximab or hypersensitivity
- •active or uncontrolled autoimmune hemolytic anemia or ITP
- •Transfusion-dependent thrombocytopenia or bleeding disorders
- •Active hepatitis B or C infections
- •History of known Human Anti-Chimeric Antibody positivity
- •History of erythema multiforme, toxic epidermal necrolysis, or Stevens-Johnson syndrome
- •History of uncontrolled seizures
- •Autoimmune disorder that requires active immunosuppression
- •Stroke or intracranial hemorrhage within last 6 months
- •History of congestive heart failure, myocardial infarction, unstable angina, uncontrolled arrhythmia or any Class 3 or 4 heart disease in the last 6 months
- •No prior malignancy except if treated with curative intent with no active disease for more than 3 years; adequately treated non-melanoma skin cancer or cervical cancer in situ
- •using warfarin or similar Vitamin K antagonists Unable to swallow capsules or disease significantly affecting gastrointestinal function or inhibiting small intestine absorption
研究组 & 干预措施
Lenalidomide, Ibrutinib, Rituximab
Rituximab on day 1, lenalidomide days 1-21 and ibrutinib continuously for 6 cycles or until disease progression or intolerance to the combination. Single agent ibrutinib will then be continued until disease progression or intolerance.
干预措施: Lenalidomide, Ibrutinib, Rituximab (Drug)
结局指标
主要结局
Recommended Phase II dose
时间窗: 1year
The dose at which less than 2 of 6 patients experience a dose limiting toxicity
次要结局
- Safety(2 years)
- Antitumor efficacy(2 years)