Phase II Study of Dasatinib (BMS-354825) in Relapsed Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Overall Objective Response
研究概览
简要总结
The purpose of this research study is to see if Dasatinib is effective and safe to give to people with relapsed chronic lymphocytic leukemia (CLL) and to determine the effects of the drug on LYN kinase activity in blood and bone marrow. Recent research shows that a key enzyme in CLL cells is responsible for cell survival. This enzyme is called LYN kinase. Laboratory studies show that inhibition of LYN kinase in CLL cells results in the death to CLL cells. Dasatinib has the ability to inhibit LYN kinase and, therefore, should have some effect on CLL cells.
详细描述
- After the screening procedures confirm that the participant is eligible and willing to participate in the research study, they will have the following tests and procedures.
- Dasatinib is given orally once daily. Each participant will have a pill diary to record doses and any missed doses. All necessary drug refills will be given during clinic appointments, at which time the pill diary and any unused study drug will be returned.
- During the first month of study treatment the participant will come to the clinic at the following intervals: Day 1: An EKG will be performed two hours after the first dose of medication; Days 3-8: Blood samples will be drawn once between days 3-8; Weeks 2-4: A physical examination, EKG and blood samples will be drawn once a week.
- Beginning with the second month of study treatment, participants will come to the clinic monthly for up to two years. The following tests and procedures will be done; physical examination (monthly), blood work (monthly), pregnancy test (monthly), EKG (monthly for 6 months, then when medically indicated), CT of the neck, chest and abdomen (every 2 months for 6 months, then once every 6 months), at the end of month 2, additional blood will be drawn for research testing.
- Participants can continue to take the study drug for up to two years as long as their disease does not progress and they are not experiencing any serious side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •18 years of age or older
- •CLL/SLL with cells positive by flow cytometry (or immunostaining) for CD19, CD23 and CD. Patients may be CD23 negative as long as they are also cyclin D1 negative.
- •Must have failed at least 1 prior fludarabine containing regimen or have failed at least 2 non-fludarabine containing regimens or have a contraindication to fludarabine use
- •ECOG performance status of 2 or better
- •Adequate organ function to tolerate chemotherapy
- •Adequate method of contraception
排除标准
- •Pregnant or breast-feeding women
- •Uncontrolled angina within 3 months
- •Diagnosed or suspected congenital long QT syndrome
- •History of clinically significant ventricular arrhythmias
- •Prolonged QTc interval on pre-entry electrocardiogram
- •Uncontrolled hypertension
- •Drugs that are generally accepted to have a risk of causing Torsades de Pointes
- •Patient known to be HIV positive
- •Known significant bleeding disorder unrelated to CLL
- •Drugs that interfere with platelet function or coagulation must be stopped at least 7 days prior to entry
研究组 & 干预措施
Dasatinib treatment
All patients were treated with dasatinib pills by mouth as treatment.
干预措施: Dasatinib (Drug)
结局指标
主要结局
Overall Objective Response
时间窗: 2 years
Overall objective response rate in terms of complete response, nodular partial response, and partial response to treatment. Objective response is when a biopsy shows. In general response is defined as the following (not complete criteria): Complete response (CR) requires all of the following for a period of at least 2 months: * Absence of lymphadenopathy * No hepatomegaly or splenomegaly * Absence of constitutional symptoms * Normal complete blood count Nodular partial response (nPR): Met the criteria for CR, but had residual bone marrow biopsy nodules as the only evidence of disease Partial response (PR): requires at least the following: * 50% decrease in peripheral blood lymphocyte count * 50% reduction in lymphadenopathy * 50% reduction in the size of the liver and/or spleen
次要结局
- Median Overall Survival(3 years)
- Median Time to Disease Progression(1 year)
- Complete Response Rate(1 year)
研究者
Philip C. Amrein, M.D.
Assistant Professor of Medicine
Massachusetts General Hospital