Combination of Lenalidomide and Rituximab in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL-SLL) as Initial Treatment or Subsequent Therapy
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Overall Response Rate
研究概览
简要总结
The goal of this clinical research study is to learn if the combination of lenalidomide and rituximab can help to control CLL. The safety of this drug combination will also be studied.
Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may decrease the growth of cancer cells.
Rituximab is designed to attach to cancer cells and damage them, which may cause the cells to die.
详细描述
Study Drug Administration:
If you are found to be eligible to take part in this study, you will begin taking the study drugs in 28-day cycles. One time a week during Cycle 1, you will receive rituximab by vein. During Cycle 2, you will not receive rituximab. During Cycles 3-12, you will receive rituximab on Day 1 of Cycles 3-12. Your first dose of rituximab will be given over 6-8 hours. If you tolerate your first dose well, you may receive the next doses over 2-4 hours. If the doctor thinks it is needed, the next doses may given over a longer time.
Starting on Day 9 of Cycle 1, you will begin taking lenalidomide by mouth 1 time a day.
The dose and schedule of lenalidomide may change depending on the side effects you may have. You should swallow lenalidomide capsules whole with a glass (8 ounces) water at the same time each day. Do not break, chew, or open the capsules. If you miss a dose of lenalidomide, take it as soon as you remember on the same day. If you miss a dose, it should NOT be made up on another day.
During Cycle 1 only, you will take allopurinol by mouth 1 time a day on Days 1-14 to lower the risk of side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Age >/-18 at the time of signing of informed consent.Understand and voluntarily sign informed consent.
- •Patients with chronic lymphocytic leukemia and untreated disease with indication for treatment that are not candidates or unwilling to receive chemoimmunotherapy, or patients of any age with previously treated CLL/SLL or recurrent disease. Patients with recurrent disease are eligible if they have received prior treatment with purine analog based chemotherapy or chemoimmunotherapy or bendamustine.
- •ECOG/WHO performance status of 0-
- •Adequate renal function indicated by serum creatinine less or equal to 2mg/dL
- •Adequate hepatic function indicated as total bilirubin less or equal to 2mg/dL and ALT less or equal to 2 times the upper limit of normal.
- •Disease free of prior malignancies for 3 years with exception of current basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. Patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in this study as long as they have a reasonable expectation to have been cured with the treatment modality received.
- •All study participants must be registered into the mandatory RevAssist program and be willing and able to comply with the program requirements.
- •Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mlU/mL within 10-14 days and again within 24 hours prior to prescribing lenalidomide for Cycle
- •Prescriptions must be filled within 7 days and must either commit to continued abstinence from heterosexual intercourse or use 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. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.
排除标准
- •Known sensitivity to lenalidomide or other thalidomide derivatives or rituximab.
- •Documented prolymphocytic leukemia (prolymphocytes more than 55% in the peripheral blood).
- •Known positivity for HIV or active hepatitis B or C.
- •Pregnant or breast feeding females.
- •History of tuberculosis treated within the last five years or recent exposure to tuberculosis.
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that places the subject at unacceptable risk if he/she were to participate in the study.
- •Patients with a recent history of deep vein thrombosis (DVT) or pulmonary embolus (PE) in the six months prior to enrollment are not eligible for the study.
研究组 & 干预措施
Prior Treatment Any Age
Patients of any age with previously treated CLL/SLL and recurrent disease.
Rituximab (375 mg/m2) will be given intravenously on Day 1, Day 8, Day 15 and Day 22 and then continued once every 4 weeks during cycles 3-12 (+ 7 days). Rituximab will not be given in Cycle 2. Lenalidomide will be started on Day 9 of cycle 1 at the dose of 10 mg/day and will be continued daily. Treatment duration will be 12 cycles and it will be possible to continue beyond 12 cycles if there is a significant benefit such as an ongoing Partial Response or Complete Response.
干预措施: Lenalidomide (Drug)
Untreated 65 +
Patients with untreated SLL/CLL with indications for treatment that are age 65 or older.
Rituximab (375 mg/m2) will be given intravenously on Day 1, Day 8, Day 15 and Day 22 and then continued once every 4 weeks during cycles 3-12 (+ 7 days). Rituximab will not be given in Cycle 2. Lenalidomide will be started on Day 9 of cycle 1 at the dose of 10 mg/day and will be continued daily. Treatment duration will be 12 cycles and it will be possible to continue beyond 12 cycles if there is a significant benefit such as an ongoing Partial Response or Complete Response.
干预措施: Rituximab (Drug)
Untreated 65 +
Patients with untreated SLL/CLL with indications for treatment that are age 65 or older.
Rituximab (375 mg/m2) will be given intravenously on Day 1, Day 8, Day 15 and Day 22 and then continued once every 4 weeks during cycles 3-12 (+ 7 days). Rituximab will not be given in Cycle 2. Lenalidomide will be started on Day 9 of cycle 1 at the dose of 10 mg/day and will be continued daily. Treatment duration will be 12 cycles and it will be possible to continue beyond 12 cycles if there is a significant benefit such as an ongoing Partial Response or Complete Response.
干预措施: Lenalidomide (Drug)
Prior Treatment Any Age
Patients of any age with previously treated CLL/SLL and recurrent disease.
Rituximab (375 mg/m2) will be given intravenously on Day 1, Day 8, Day 15 and Day 22 and then continued once every 4 weeks during cycles 3-12 (+ 7 days). Rituximab will not be given in Cycle 2. Lenalidomide will be started on Day 9 of cycle 1 at the dose of 10 mg/day and will be continued daily. Treatment duration will be 12 cycles and it will be possible to continue beyond 12 cycles if there is a significant benefit such as an ongoing Partial Response or Complete Response.
干预措施: Rituximab (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: 6 months
Participants evaluated for response by 2008 International Workshop on Chronic Lymphocytic Leukemia \[IWCLL\] overall response criteria by 6 months of treatment. Bone marrow biopsy and aspiration to check the status of the disease. Responses assessed after 3, 6 and 12 cycles.
次要结局
未报告次要终点