B-Cell Chronic Lymphocytic Leukemia
Conditions
Keywords
untreated
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.
Interventions
DRUGHydroxychloroquine
400mg by mouth daily x 1 year
Sponsors
Northwell Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Response | 1 yr | Percentage of participants with a reduction of the absolute lymphocytic count- ALC |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Next Treatment | 1 yr | number of months to time from last HCQ dose to next CLL treatment |
Countries
United States
Participant flow
Recruitment details
Recruitment was from April 2009 through termination December 2011. Patients were identified and enrolled in the CLL Research and Treatment Program where they already were being seen for care of their CLL.
Participants by arm
| Arm | Count |
|---|---|
| Hydroxychloroquine Hydroxychloroquine 400 mg po daily for up to one year. | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | Hydroxychloroquine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Age, Continuous | 59 years |
| Region of Enrollment United States | 23 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
Percentage of Participants With Response
Percentage of participants with a reduction of the absolute lymphocytic count- ALC
Time frame: 1 yr
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hydroxychloroquine | Percentage of Participants With Response | 54.4 percentage of participants |
Secondary
Time to Next Treatment
number of months to time from last HCQ dose to next CLL treatment
Time frame: 1 yr
Population: only analyzed for participants that were treated within one year post last dose of hydroxychloroquine dose
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Hydroxychloroquine | Time to Next Treatment | 4.3 months |