Hydroxychloroquine in Untreated B-CLL Patients

• Status: Terminated
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwell Health
• Treatments: Hydroxychloroquine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Pregnancy

• Significant optic nerve pathology as documented by an opthalmologic exam

• Hypersensitivity to 4-aminoquinoline compound

• Patients taking cardiac glycosides and cyclosporine