Hydroxychloroquine in Untreated B-CLL Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Study to Evaluate the Tolerability and Efficacy of Treatment of Previously Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients With Hydroxychloroquine.

Conditions
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B-Cell Chronic Lymphocytic Leukemia

Intervention / Treatment
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* Drug: Hydroxychloroquine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydroxychloroquine<br>Hydroxychloroquine 400 mg po daily for up to one year. | Drug: Hydroxychloroquine<br>* 400mg by mouth daily x 1 year<br>* Other names: Plaquenil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Response | Percentage of participants with a reduction of the absolute lymphocytic count- ALC | 1 yr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Next Treatment | number of months to time from last HCQ dose to next CLL treatment | 1 yr | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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untreated