Hydroxychloroquine in Untreated B-CLL Patients

NCT ID: NCT00771056

Last Updated: 2016-08-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2012-01-31

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.

Conditions

B-Cell Chronic Lymphocytic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hydroxychloroquine

Hydroxychloroquine 400 mg po daily for up to one year.

Group Type: EXPERIMENTAL

Hydroxychloroquine

Intervention Type: DRUG

400mg by mouth daily x 1 year

Interventions

Hydroxychloroquine

400mg by mouth daily x 1 year

Intervention Type: DRUG

Other Intervention Names

Plaquenil

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Kanti Rai, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kanti R Rai, MD

Role: PRINCIPAL_INVESTIGATOR

NSLIJ

Locations

Long Island Jewish Medical Center CLL Research and Treatment Center

New Hyde Park, New York, United States

Countries

United States

Other Identifiers

08-088

Identifier Type: -

Identifier Source: org_study_id