Hydroxychloroquine in Untreated B-CLL Patients

B-Cell Chronic Lymphocytic Leukemia Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00771056
• Other study ID #: 08-088
• Status: Terminated
• Phase: Phase 2
• First received: October 8, 2008
• Last updated: August 18, 2016
• Start date: July 2008
• Est. completion date: January 2012

Study information

• Verified date: August 2016
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• B-Cell Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• Hydroxychloroquine
400mg by mouth daily x 1 year

Locations

Country	Name	City	State
United States	Long Island Jewish Medical Center CLL Research and Treatment Center	New Hyde Park	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Response	Percentage of participants with a reduction of the absolute lymphocytic count- ALC	1 yr	No
Secondary	Time to Next Treatment	number of months to time from last HCQ dose to next CLL treatment	1 yr	No