Hydroxychloroquine in Untreated B-CLL Patients
Primary Purpose
B-Cell Chronic Lymphocytic Leukemia
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hydroxychloroquine
Sponsored by
About this trial
This is an interventional treatment trial for B-Cell Chronic Lymphocytic Leukemia focused on measuring untreated
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
Sites / Locations
- Long Island Jewish Medical Center CLL Research and Treatment Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hydroxychloroquine
Arm Description
Hydroxychloroquine 400 mg po daily for up to one year.
Outcomes
Primary Outcome Measures
Percentage of Participants With Response
Percentage of participants with a reduction of the absolute lymphocytic count- ALC
Secondary Outcome Measures
Time to Next Treatment
number of months to time from last HCQ dose to next CLL treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00771056
Brief Title
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
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
study suspended while data is reviewed for safety and efficacy.
Study Start Date
July 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-Cell Chronic Lymphocytic Leukemia
Keywords
untreated
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydroxychloroquine
Arm Type
Experimental
Arm Description
Hydroxychloroquine 400 mg po daily for up to one year.
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Other Intervention Name(s)
Plaquenil
Intervention Description
400mg by mouth daily x 1 year
Primary Outcome Measure Information:
Title
Percentage of Participants With Response
Description
Percentage of participants with a reduction of the absolute lymphocytic count- ALC
Time Frame
1 yr
Secondary Outcome Measure Information:
Title
Time to Next Treatment
Description
number of months to time from last HCQ dose to next CLL treatment
Time Frame
1 yr
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kanti R Rai, MD
Organizational Affiliation
NSLIJ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Long Island Jewish Medical Center CLL Research and Treatment Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to contact each individual patient (participant in the trial) and inform hem/her of results of this trial as it affects each one of them.
Learn more about this trial
Hydroxychloroquine in Untreated B-CLL Patients
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