Hydroxychloroquine in Untreated B-CLL Patients
This study has suspended participant recruitment.
(study suspended while data is reviewed for safety and efficacy.)
Sponsor:
North Shore Long Island Jewish Health System
Information provided by:
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00771056
First received: October 8, 2008
Last updated: May 26, 2011
Last verified: May 2011
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 8, 2008 | ||||
| Last Updated Date | May 26, 2011 | ||||
| Start Date ICMJE | July 2008 | ||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Stabilization or decrease in measurable disease by CBC and/or physical exam [ Time Frame: 1 yr ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00771056 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Time to next treatment [ Time Frame: 1 yr ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Hydroxychloroquine in Untreated B-CLL Patients | ||||
| Official Title ICMJE | Phase II Study to Evaluate the Tolerability and Efficacy of Treatment of Previously Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients With Hydroxychloroquine. | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | B-Cell Chronic Lymphocytic Leukemia | ||||
| Intervention ICMJE | Drug: Hydroxychloroquine
400mg by mouth daily x 1 year
Other Name: Plaquenil |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Suspended | ||||
| Estimated Enrollment ICMJE | 33 | ||||
| Estimated Completion Date | January 2012 | ||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00771056 | ||||
| Other Study ID Numbers ICMJE | 08-088 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Kanti Rai, MD, NSLIJ | ||||
| Study Sponsor ICMJE | North Shore Long Island Jewish Health System | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | North Shore Long Island Jewish Health System | ||||
| Verification Date | May 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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