Hydroxychloroquine in Untreated B-CLL Patients
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|ClinicalTrials.gov Identifier: NCT00771056|
Recruitment Status : Terminated (study suspended while data is reviewed for safety and efficacy.)
First Posted : October 10, 2008
Results First Posted : July 26, 2016
Last Update Posted : August 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|B-Cell Chronic Lymphocytic Leukemia||Drug: Hydroxychloroquine||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||July 2008|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Hydroxychloroquine 400 mg po daily for up to one year.
400mg by mouth daily x 1 year
Other Name: Plaquenil
- Percentage of Participants With Response [ Time Frame: 1 yr ]Percentage of participants with a reduction of the absolute lymphocytic count- ALC
- Time to Next Treatment [ Time Frame: 1 yr ]number of months to time from last HCQ dose to next CLL treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00771056
|United States, New York|
|Long Island Jewish Medical Center CLL Research and Treatment Center|
|New Hyde Park, New York, United States, 11040|
|Principal Investigator:||Kanti R Rai, MD||NSLIJ|