Lenalidomide in Combination With Rituximab as Treatment for Patients With Relapsed Chronic Lymphocytic Leukemia - RV-CLL-PI-0292
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall Participant Response Rate: Percentage of Participants With Complete + Partial Response According to Revised National Cancer Institute-sponsored Working Group Guidelines
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 Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) in patients who have already received therapy. The safety of this drug combination will also be studied.
详细描述
The Study Drugs:
Lenalidomide is designed to change the body's immune system and may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may decrease the growth of cancer cells.
Rituximab is designed to bind to a protein, called cluster of differentiation antigen 20 (CD20), that is on the surface of the leukemia cells, allowing the leukemia cells to be destroyed by the immune system.
Drug Administration:
If you are found to be eligible to take part in this study, you will receive rituximab through a needle into your vein 1 time a week in Cycle 1. You will not receive rituximab during Cycle 2, but you will continue to take lenalidomide.You will receive a dose of rituximab by vein on Day 1 of Cycles 3-12. Your first dose of rituximab will be given over 6-8 hours. If the first dose is well tolerated, 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.
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
- •Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with active disease.
- •Patients must be age 18 or over at the signing of consent and must understand and voluntarily sign an informed consent.
- •Prior treatment with purine analog based chemotherapy or chemoimmunotherapy.
- •Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 0-
- •Adequate renal function indicated by serum creatinine less or equal to 2 mg/dl. Adequate hepatic function indicated as total bilirubin less or equal to 2 mg/dl and ALT less or equal to two times the upper limit of normal.
- •Disease free of prior malignancies for 3 years with exception of currently treated 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 the study as long as they have a reasonable expectation to have been cured with the treatment modality received.
- •Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test (sensitivity of at least 50 milli-International unit (mIU/mL) 10-14 days prior to starting lenalidomide. A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- •Continued from Criteria #
- •FCBP 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 talking lenalidomide. FCBP must also agree to ongoing pregnancy testing.
- •Continued from Criteria #8: Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
- •Men must agree not to father a child. They must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a vasectomy. They will be warned that sharing study drug is prohibited and will be counseled about pregnancy precautions and potential risks of fetal exposure. They must agree to abstain from donating blood, semen, or sperm during study participation and for at least 28 days after discontinuation from the study.
- •Continued from Criteria #10: Counseling about the requirement for latex condom use during sexual contact with females of childbearing potential and the potential risks of fetal exposure must be conducted at a minimum of every 28 days. During counseling, subjects must be reminded not to share study drug and to not donate blood, sperm, or semen (during study participation and for 28 days following discontinuation from the study).
排除标准
- •Known sensitivity to lenalidomide or other thalidomide derivatives or rituximab.
- •Documented prolymphocytic leukemia (prolymphocytes more than 55% in the 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 this study.
研究组 & 干预措施
Lenalidomide + Rituximab
Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
干预措施: Lenalidomide (Drug)
Lenalidomide + Rituximab
Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
干预措施: Rituximab (Drug)
结局指标
主要结局
Overall Participant Response Rate: Percentage of Participants With Complete + Partial Response According to Revised National Cancer Institute-sponsored Working Group Guidelines
时间窗: Responses assessed after 12 cycles, up to 48 weeks with interim assessments performed after 3, 6 and 12 cycles.
Complete response: Absence lymphadenopathy, hepatomegaly or splenomegaly \& constitutional symptoms; Normal complete blood count (CBC) exhibited by polymorphonuclear leukocytes\>1500/µL, platelets\>100,000/µL, hemoglobin\>11.0 g/dL (untransfused); lymphocyte count \<5,000/µL; Bone marrow aspirate \& biopsy normocellular for age with \<30% nucleated cells lymphocytes; Absence Lymphoid nodules. Fulfillment CR criteria after induction with exception of treatment related persistent cytopenia \& bone marrow lymphoid nodules both considered partial response; Partial response: Requires 50% decrease in peripheral lymphocytes from pre-treatment, 50% reduction in lymphadenopathy, \&/or 50% reduction in splenomegaly/hepatomegaly for 2+ months from therapy completion. Additionally one following from pre-treatment: Polymorphonuclear leukocytes 1,500/µL or 50% improvement; Platelets\>100,000/µL or 50% improvement; Hemoglobin\>11.0 g/dL (untransfused) or 50% improvement.
次要结局
未报告次要终点