Hydroxychloroquine in Untreated B-CLL Patients

Verified by: North Shore Long Island Jewish Health System, May 2011
First Received: October 8, 2008 | Last Updated: May 26, 2011 | Phase: Phase 2 | Start Date: July 2008
Overall Status: Suspended | Estimated Enrollment: 33
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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...

Brief Summary

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.”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: January 2012

Intervention(s) in this Clinical Trial

  • Drug: Hydroxychloroquine
    • 400mg by mouth daily x 1 year

Outcome Measures for this Clinical Trial

Primary Measures

  • Stabilization or decrease in measurable disease by CBC and/or physical exam
    • Time Frame: 1 yr
      Safety Issue?: No

Secondary Measures

  • Time to next treatment
    • Time Frame: 1 yr
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: North Shore Long Island Jewish Health System Other

Overall Clinical Trial Officials and Contacts

Kanti R Rai, MD Principal Investigator NSLIJ  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00771056

Study ID Number: 08-088

ClinicalTrials.gov Identifier: NCT00771056

Health Authority: United States: Institutional Review Board

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