Continuous Infusion of Campath-1H Followed by Subcutaneous Injections in Previously Treated Patients With Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Response Rate (CR+PR) to CAMPATH-1H
研究概览
简要总结
The goal of this clinical research study is to learn if giving CAMPATH-1H first as an injection into a vein, then as an injection under the skin can shrink or slow the growth of the disease in patients with chronic lymphocytic leukemia (CLL) who have already received standard therapy. Another goal is to learn if the side effects related to CAMPATH-1H treatment are less severe by giving the drug first as an injection into a vein then as an injection under the skin.
详细描述
The purposes of this trial are:
- To evaluate the response rate (CR+PR) to CAMPATH-1H given as continuous infusion followed by subcutaneous injection in patients with previously treated CLL who have failed fludarabine therapy.
- To evaluate whether CAMPATH-1H, given as a continuous infusion followed by subcutaneous injections to patients with previously treated CLL will improve tolerability of the agent and permit higher doses to be delivered through that route.
- To evaluate the pharmacokinetics of CAMPATH-1H when given as a 24 hour continuous infusion followed by a subcutaneous injection.
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
- •Age >= 18 years (CLL does not occur in the pediatric population).
- •Signed informed consent.
- •World Health Organization (WHO) performance status of 0, 1, or
- •Patients with B-CLL who have received fludarabine and are either refractory to frontline therapy or have relapsed within six months from receiving fludarabine-based therapy. Patients previously treated with Campath-1H are eligible.
- •Serum creatinine <= 2mg/dL, total bilirubin <= 2mg/dL, and SGPT <= 3x upper limit of normal (ULN) unless due to direct infiltration of the liver or kidney with malignant cells.
排除标准
- •Past history of anaphylaxis, following exposure to rat or mouse derived CDR-grafted humanized monoclonal antibodies.
- •Prior chemotherapy, immunotherapy, or hormonal therapy within 2 weeks prior to study start. Hormonal replacement therapy is permitted. Prior therapy with monoclonal antibodies for at least 4 weeks prior to study start.
- •Pregnant or nursing women or any patient of childbearing age unwilling to practice an acceptable form of contraception.
- •Patients with history of HIV positivity.
- •Active secondary malignancy.
- •Active uncontrolled infection or any major systemic or other illness that would, in the opinion of the investigator, interfere with the patient's ability to comply with the protocol, compromise patient safety or interfere with the interpretation of study results.
研究组 & 干预措施
CAMPATH-1H
15 mg infused daily for continuous infusion x 7 days; starting day 10, CAMPATH-1H 30 mg subcutaneously three times weekly for 11 additional weeks.
干预措施: Campath-1H (Drug)
结局指标
主要结局
Response Rate (CR+PR) to CAMPATH-1H
时间窗: 3 months
Rate is number of patients with CR+PR response to CAMPATH-1H where CR is Complete Response and PR is Partial Response RECIST.
次要结局
未报告次要终点