Clinical trial NCT00771056: Hydroxychloroquine in Untreated B-CLL Patients
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: B-Cell Chronic Lymphocytic Leukemia
Keywords: untreated
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2008-10-10
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Participants With Response
timeFrame: 1 yr
Secondary outcomes:
measure: Time to Next Treatment
timeFrame: 1 yr
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center CLL Research and Treatment Center
state: New York
Study officials:
affiliation: NSLIJ
name: Kanti R Rai, MD
role: PRINCIPAL_INVESTIGATOR
References: