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Hydroxychloroquine in Untreated B-CLL Patients

This study has suspended participant recruitment.
(study suspended while data is reviewed for safety and efficacy.)
Sponsor:
Information provided by:
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00771056
First received: October 8, 2008
Last updated: May 26, 2011
Last verified: May 2011
History of Changes
  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: Allocation: Non-Randomized
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:

U.S. FDA Resources

Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Stabilization or decrease in measurable disease by CBC and/or physical exam [ Time Frame: 1 yr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to next treatment [ Time Frame: 1 yr ] [ Designated as safety issue: No ]

Estimated Enrollment: 33
Study Start Date: July 2008
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Hydroxychloroquine
    400mg by mouth daily x 1 year
    Other Name: Plaquenil
  Eligibility

Ages Eligible for Study:   18 Years and older
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
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
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Kanti R Rai, MD NSLIJ
  More Information

No publications provided

Responsible Party: Kanti Rai, MD, NSLIJ
ClinicalTrials.gov Identifier: NCT00771056     History of Changes
Other Study ID Numbers: 08-088
Study First Received: October 8, 2008
Last Updated: May 26, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
untreated

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

ClinicalTrials.gov processed this record on May 23, 2013