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Hydroxychloroquine in Untreated B-CLL Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Kanti Rai, MD, Northwell Health

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.

Condition or disease Intervention/treatment Phase
B-Cell Chronic Lymphocytic Leukemia Drug: Hydroxychloroquine Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Hydroxychloroquine
Hydroxychloroquine 400 mg po daily for up to one year.
Drug: Hydroxychloroquine
400mg by mouth daily x 1 year
Other Name: Plaquenil

Primary Outcome Measures :
  1. Percentage of Participants With Response [ Time Frame: 1 yr ]
    Percentage of participants with a reduction of the absolute lymphocytic count- ALC

Secondary Outcome Measures :
  1. Time to Next Treatment [ Time Frame: 1 yr ]
    number of months to time from last HCQ dose to next CLL treatment

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00771056

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United States, New York
Long Island Jewish Medical Center CLL Research and Treatment Center
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
Northwell Health
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Principal Investigator: Kanti R Rai, MD NSLIJ
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Responsible Party: Kanti Rai, MD, Principal Investigator, Northwell Health Identifier: NCT00771056    
Other Study ID Numbers: 08-088
First Posted: October 10, 2008    Key Record Dates
Results First Posted: July 26, 2016
Last Update Posted: August 22, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.
Keywords provided by Kanti Rai, MD, Northwell Health:
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents