Hydroxychloroquine in Untreated B-CLL Patients

Phase 2

Terminated

• Conditions: B-Cell Chronic Lymphocytic Leukemia
• Interventions: Drug: Hydroxychloroquine

• Registration Number: NCT00771056
• Lead Sponsor: Northwell Health

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 Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-10-08
• Study First Submitted QC: 2008-10-09
• Study First Posted: 2008-10-10
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Results First Submitted: 2015-12-17
• Results First Submitted QC: 2016-06-15
• Results First Posted: 2016-07-26
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-18
• Last Update Posted: 2016-08-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hydroxychloroquine	Hydroxychloroquine	Hydroxychloroquine 400 mg po daily for up to one year.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Response	1 yr	Percentage of participants with a reduction of the absolute lymphocytic count- ALC

Secondary Outcome Measures

Name	Time	Method
Time to Next Treatment	1 yr	number of months to time from last HCQ dose to next CLL treatment

Trial Locations

Locations (1)

Long Island Jewish Medical Center CLL Research and Treatment Center; 🇺🇸 New Hyde Park, New York, United States