Hydroxychloroquine in Untreated B-CLL Patients

August 18, 2016 updated by: Kanti Rai, MD, Northwell Health

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center CLL Research and Treatment Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Plaquenil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Response
Time Frame: 1 yr
Percentage of participants with a reduction of the absolute lymphocytic count- ALC
1 yr

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Next Treatment
Time Frame: 1 yr
number of months to time from last HCQ dose to next CLL treatment
1 yr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Investigators

  • Principal Investigator: Kanti R Rai, MD, NSLIJ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

October 8, 2008

First Submitted That Met QC Criteria

October 9, 2008

First Posted (ESTIMATE)

October 10, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 22, 2016

Last Update Submitted That Met QC Criteria

August 18, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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