Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT00771056
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 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:
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.
Study:
NCT00771056
Study Brief:
Protocol Section:
NCT00771056