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Hydroxychloroquine in Untreated B-CLL Patients

This study has been terminated.
(study suspended while data is reviewed for safety and efficacy.)
Sponsor:
Information provided by (Responsible Party):
Kanti Rai, MD, Northwell Health
ClinicalTrials.gov Identifier:
NCT00771056
First received: October 8, 2008
Last updated: August 18, 2016
Last verified: August 2016
  Purpose
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 Intervention Phase
B-Cell Chronic Lymphocytic Leukemia
Drug: Hydroxychloroquine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Northwell Health:

Primary Outcome Measures:
  • Percentage of Participants With Response [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
    Percentage of participants with a reduction of the absolute lymphocytic count- ALC


Secondary Outcome Measures:
  • Time to Next Treatment [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
    number of months to time from last HCQ dose to next CLL treatment


Enrollment: 23
Study Start Date: July 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hydroxychloroquine
Hydroxychloroquine 400 mg po daily for up to one year.
Drug: Hydroxychloroquine
400mg by mouth daily x 1 year
Other Name: Plaquenil

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771056

Locations
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
Investigators
Principal Investigator: Kanti R Rai, MD NSLIJ
  More Information

Responsible Party: Kanti Rai, MD, Principal Investigator, Northwell Health
ClinicalTrials.gov Identifier: NCT00771056     History of Changes
Other Study ID Numbers: 08-088 
Study First Received: October 8, 2008
Results First Received: December 17, 2015
Last Updated: August 18, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
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 Northwell Health:
untreated

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 30, 2016