Maintenance Alemtuzumab in Refractory Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Time to Progression (Months)
研究概览
简要总结
This is a study designed to test whether giving campath (also known as alemtuzumab) on a maintenance schedule will prolong the time until the patient requires chemotherapy.
详细描述
This is an open-label, single arm, proof-of-principle study of Campath (also known as alemtuzumab) maintenance therapy administered subcutaneously at varying intervals for up to 1 year. Ongoing prophylactic anti-infectives will be provided. Patients will be assessed for response every 2 months and for quality of life every 3 months while on treatment. Patients achieving a presumptive complete response will receive no further treatment but will be followed for response. Non-responding patients, with confirmed progressing disease following a minimum of 8 doses will be discontinued from treatment and followed for survival. Responding patients or patients with stable disease will undergo confirmatory assessment 2 months following their end-of-treatment assessment. If remission has occurred, patients will be followed off treatment until documented disease progression.
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
- •Enrollment in this study is open to patients 18 years of age with confirmed chronic lymphocytic leukemia, a clinical response of stable disease or better to previous treatment, and an Eastern Cooperative Oncology Group performance status of 0-2
排除标准
- •Treatment failure in more than 3 prior regimens
- •Active secondary malignancy
- •Central nervous system involvement with CLL
- •History of significant allergic reaction to antibody therapies that required discontinuation of the antibody therapy
- •History of HIV positivity
- •Hepatitis C virus (HCV) positivity based upon core antigen testing
- •Active infection, requiring treatment with antibiotic, antiviral, or antifungal agents
- •Pregnancy or lactation
- •Other severe, concurrent diseases or mental disorders
研究组 & 干预措施
Campath maintenance treatment
Single arm, open label trial of Campath on a maintenance schedule for patients who have had a response to prior conventional chemotherapy. Treatments consist of dose escalation (3, 10 and 30mg) during week 1 followed by weekly dosing of Campath at 30 mg once weekly for 7 weeks followed by Campath 30 mg every 2 weeks for 16 weeks followed by Campath 30 mg once every 3 weeks for 24 weeks. Total duration of treatment up to 48 weeks.
干预措施: Campath (Drug)
结局指标
主要结局
Time to Progression (Months)
时间窗: Every 8 weeks
Time to progression calculated as the period, in months, between the date of the first dose of alemtuzumab and the first date of documented disease progression (NCI 1996 criteria) or death. Duration of response of all other participants who did not progress nor expire, had their event times calculated at the last date of follow-up.
次要结局
- Rate of Infections(Weekly then every 2 weeks then every 3 weeks)
研究者
Kanti Rai, MD
Principal Investigator
Northwell Health