Phase II Study to Evaluate the Tolerability and Efficacy of Treatment of Previously Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients With Hydroxychloroquine.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Response
研究概览
简要总结
Eligible CLL patients who sign an informed consent will be started on hydroxychloroquine 400mg po daily for up to one year. They will be monitored for disease status as well as adverse reactions after two weeks and then every 4 weeks. Ophthalmologic exams is required at baseline and every 6 months or sooner if the patient develops any visual disturbances.
详细描述
This is a single-center, open-label, single arm Phase 2 study evaluating the feasibility, and efficacy of treating CLL subjects with hydroxychloroquine. The study schema and schedule of events are as follows:
Prior to beginning hydroxychloroquine:
- Blood samples to be taken.
- Baseline tests confirming diagnosis of CLL as defined above (if not already obtained in records)
- Physical exam performed
- Either six months prior or 4 weeks within starting HCQ ophthalmologic exam documented
- Days 1-365 subject takes hydroxychloroquine 400mg/day
- At 2 weeks: CBC and chemistry
- Every 4 weeks: CBC, chemistry, history (including the inquiry about the presence or absence of visual symptoms) and physical exam.
- Starting at 4 weeks: blood samples taken for laboratory companion studies taken at office visit every 8 weeks.
- At 6 months (+ or - 30 days): subject will have follow up ophthalmologic exam). This will also be done in the presence of any visual/ocular symptoms.
All subjects must meet the selection criteria for registration in this study. All subjects must have a peripheral blood sample submitted. It is estimated that approximately 70 subjects will be screened. The anticipated accrual period is 12 months.
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
- •Flow cytometry confirmed B-CLL
- •No prior chemotherapy or immunotherapy
- •Performance status 0-2
- •Age > 18 years old
- •If childbearing age, woman you must be willing to use birth control for length of hydroxychloroquine use
- •Must have capacity to consent for study and sign consent form
- •Asymptomatic CLL not requiring treatment at time of study entry
排除标准
- •Pregnancy
- •Significant optic nerve pathology as documented by an opthalmologic exam
- •Hypersensitivity to 4-aminoquinoline compound
- •Patients taking cardiac glycosides and cyclosporine
研究组 & 干预措施
Hydroxychloroquine
Hydroxychloroquine 400 mg po daily for up to one year.
干预措施: Hydroxychloroquine (Drug)
结局指标
主要结局
Percentage of Participants With Response
时间窗: 1 yr
Percentage of participants with a reduction of the absolute lymphocytic count- ALC
次要结局
- Time to Next Treatment(1 yr)
研究者
Kanti Rai, MD
Principal Investigator
Northwell Health
