Hydroxychloroquine in Untreated B-CLL Patients
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- Percentage of Participants With Response [ Time Frame: 1 yr ] [ Designated as safety issue: No ]Percentage of participants with a reduction of the absolute lymphocytic count- ALC
- Time to Next Treatment [ Time Frame: 1 yr ] [ Designated as safety issue: No ]number of months to time from last HCQ dose to next CLL treatment
|Study Start Date:||July 2008|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Hydroxychloroquine 400 mg po daily for up to one year.
400mg by mouth daily x 1 year
Other Name: Plaquenil
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00771056
|United States, New York|
|Long Island Jewish Medical Center CLL Research and Treatment Center|
|New Hyde Park, New York, United States, 11040|
|Principal Investigator:||Kanti R Rai, MD||NSLIJ|