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...
Date First Received: October 8, 2008
Last Updated: April 22, 2009
Verified by: North Shore Long Island Jewish Health System, April 2009
Clinical Trial Phase: Phase 2 | Start Date: July 2008
Overall Status: Recruiting
Estimated Enrollment: 33
Brief Summary
Official Title: “Phase II Study to Evaluate the Tolerability and Efficacy of Treatment of Previously Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients With Hydroxychloroquine.”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Study Primary Completion Date: January 2010
Intervention(s) in this Clinical Trial
- Drug: Hydroxychloroquine
- 400mg by mouth daily x 1 year
Outcome Measures for this Clinical Trial
Primary Measures
- Stabilization or decrease in measurable disease by CBC and/or physical exam
- Time Frame: 1 yr
Safety Issue?: No
- Time Frame: 1 yr
Secondary Measures
- Time to next treatment
- Time Frame: 1 yr
Safety Issue?: No
- Time Frame: 1 yr
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: North Shore Long Island Jewish Health System
Overall Clinical Trial Officials and Contacts
Matthew Kaufman, MD Principal Investigator NSLIJ
Overall Contact: Angelica Caramanica, PA 718-470-4050 acaraman@.nshs.edu
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00771056
Study ID Number: 08-088
ClinicalTrials.gov Identifier: NCT00771056
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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