Phase II Study to Evaluate the Tolerability and Efficacy of Treatment of Previously Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients With Hydroxychloroquine.
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
B-Cell Chronic Lymphocytic Leukemia
Both
B-Cell Chronic Lymphocytic Leukemia
Trial Information
Phase II Study to Evaluate the Tolerability and Efficacy of Treatment of Previously Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients With Hydroxychloroquine.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Stabilization or decrease in measurable disease by CBC and/or physical exam
Outcome Time Frame:
1 yr
Safety Issue:
No
Principal Investigator
Kanti R Rai, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
NSLIJ
Authority:
United States: Institutional Review Board
Study ID:
08-088
NCT ID:
NCT00771056
Start Date:
July 2008
Completion Date:
January 2012
Related Keywords:
- B-cell Chronic Lymphocytic Leukemia
- untreated
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
Name | Location |
|---|---|
| Long Island Jewish Medical Center CLL Research and Treatment Center | New Hyde Park, New York 11040 |
