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study suspended while data is reviewed for safety and efficacy.
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydroxychloroquine | Experimental | Hydroxychloroquine 400 mg po daily for up to one year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine | Drug | 400mg by mouth daily x 1 year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Response | Percentage of participants with a reduction of the absolute lymphocytic count- ALC | 1 yr |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Next Treatment | number of months to time from last HCQ dose to next CLL treatment | 1 yr |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kanti R Rai, MD | NSLIJ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long Island Jewish Medical Center CLL Research and Treatment Center | New Hyde Park | New York | 11040 | United States |
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.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hydroxychloroquine | Hydroxychloroquine 400 mg po daily for up to one year. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hydroxychloroquine | Hydroxychloroquine 400 mg po daily for up to one year. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Response | Percentage of participants with a reduction of the absolute lymphocytic count- ALC | Posted | Number | percentage of participants | 1 yr |
|
|
Adverse event reporting wil be reported if applicable as subjects are monitored on a monthly basis.
Subjects were monitored monthly by physician for adverse events from hydroxychloroquine.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hydroxychloroquine | Hydroxychloroquine 400 mg po daily for up to one year. Hydroxychloroquine: 400mg by mouth daily x 1 year |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kanti R Rai, MD | Northwell Health (formerly North Shore LIJ Health System) | (718)470-4050 | krai@nshs.edu |
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| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Time to Next Treatment | number of months to time from last HCQ dose to next CLL treatment | only analyzed for participants that were treated within one year post last dose of hydroxychloroquine dose | Posted | Mean | Full Range | months | 1 yr |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
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| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |