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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.
 
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
Sponsor:
Information provided by (Responsible Party):
Kanti Rai, MD, Northwell Health

Tracking Information
First Submitted Date  ICMJE October 8, 2008
First Posted Date  ICMJE October 10, 2008
Results First Submitted Date  ICMJE December 17, 2015
Results First Posted Date  ICMJE July 26, 2016
Last Update Posted Date August 22, 2016
Study Start Date  ICMJE July 2008
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2016)
Percentage of Participants With Response [ Time Frame: 1 yr ]
Percentage of participants with a reduction of the absolute lymphocytic count- ALC
Original Primary Outcome Measures  ICMJE
 (submitted: October 9, 2008)
Stabilization or decrease in measurable disease by CBC and/or physical exam [ Time Frame: 1 yr ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2016)
Time to Next Treatment [ Time Frame: 1 yr ]
number of months to time from last HCQ dose to next CLL treatment
Original Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2008)
Time to Next Treatment [ Time Frame: 1 yr ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE B-Cell Chronic Lymphocytic Leukemia
Intervention  ICMJE Drug: Hydroxychloroquine
400mg by mouth daily x 1 year
Other Name: Plaquenil
Study Arms  ICMJE Experimental: Hydroxychloroquine
Hydroxychloroquine 400 mg po daily for up to one year.
Intervention: Drug: Hydroxychloroquine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 18, 2016)
23
Original Estimated Enrollment  ICMJE
 (submitted: October 9, 2008)
33
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00771056
Other Study ID Numbers  ICMJE 08-088
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Responsible Party Kanti Rai, MD, Northwell Health
Study Sponsor  ICMJE Northwell Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kanti R Rai, MD NSLIJ
PRS Account Northwell Health
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP