Status:
TERMINATED
Hydroxychloroquine in Untreated B-CLL Patients
Lead Sponsor:
Northwell Health
Conditions:
B-Cell Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- Pregnancy
- Significant optic nerve pathology as documented by an opthalmologic exam
- Hypersensitivity to 4-aminoquinoline compound
- Patients taking cardiac glycosides and cyclosporine
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00771056
Start Date
July 1 2008
End Date
January 1 2012
Last Update
August 22 2016
Active Locations (1)
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1
Long Island Jewish Medical Center CLL Research and Treatment Center
New Hyde Park, New York, United States, 11040