A Phase I-II Trial of Gleevec (Imatinib Mesylate) in Combination With Chlorambucil in Previously Treated Chronic Lymphocytic Leukemia (CLL) Patients
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Measure number of patients at maximum tolerated dose of Gleevec in combination with chlorambucil
研究概览
简要总结
The purpose of this study is to determine maximum tolerated dose of Gleevec in combination with Chlorambucil in previously treated CLL patients.
详细描述
A recent study by Aloyz et al demonstrated a synergistic effect of imatinib on chlorambucil-mediated cytotoxicity in CLL cells in vitro. Imatinib inhibits c-abl and sensitizes cells to chlorambucil. The Phase I component of the study will determine the maximum tolerated dose and recommended Phase II dose of Gleevec when used in combination with chlorambucil. Once the maximum tolerated dose has been determined, a total of 16 patients will be enrolled in the Phase II component of the study. This study will determine the dose limiting toxicities, pharmacokinetics and pharmacodynamics of Gleevec in combination with chlorambucil.
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
- •B-cell chronic lymphocytic leukemia (a) Rai stage 0-II with indication for treatment by NCI Working Group Criteria: or (b) Rai stage III or IV.
- •Received a minimum of one prior chemotherapy regimen. Prior treatment with corticosteroids, immunotherapies, monoclonal antibodies or radiation therapy is permitted.
- •White blood cell count > 25 x 10^9/L
- •ECOG 0, 1,or
- •Adequate renal and hepatic function
- •Platelets > 75 x 10^9/L, transfusion independent.
- •Neutrophils > 1.0 x 10^9/L, transfusion independent
排除标准
- •Documented prolymphocytic leukemia (PLL; prolymphocytes, 55% in blood)
- •Active cardiovascular disease as defined by NYHA class III-IV categorization.
- •Intercurrent illness or medical condition precluding safe administration of ribavirin.
- •Concurrent use of chronic steroids, except as replacement therapy for adrenal insufficiency
- •Known infection with HIV, Hepatitis B or C.
- •Concurrent malignancy (other than resected basal or squamous cell skin cancers or in-situ carcinoma).
- •Received any previous therapy for CLL within 28 days prior to study entry.
研究组 & 干预措施
I
Gleevec Chlorambucil
干预措施: Gleevec and Chlorambucil (Drug)
结局指标
主要结局
Measure number of patients at maximum tolerated dose of Gleevec in combination with chlorambucil
时间窗: 1 month
次要结局
- Report level of gleevec concentration at different doses as a measure of pharmacokinetics(1 month)
- Report response to treatment as a measure of efficacy(6 months)
- Report adverse events as a measure of safety(6 months)
研究者
Sarit Assouline
Associate Professor, Department of Oncology, McGill University
Jewish General Hospital